CELEX: 
Language: en
Date: 2017-02-22
Title: Position of the Council at first reading with a view to the adoption of a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

Council of the
                 European Union
                                                           Brussels, 22 February 2017
                                                           (OR. en)
                                                           10728/16
       Interinstitutional File:
          2012/0266 (COD)
                                                           PHARM 43
                                                           SAN 284
                                                           MI 478
                                                           COMPET 402
                                                           CODEC 977
LEGISLATIVE ACTS AND OTHER INSTRUMENTS
Subject:            Position of the Council at first reading with a view to the adoption of a
                    REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE
                    COUNCIL on medical devices, amending Directive 2001/83/EC, Regulation
                    (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing
                    Council Directives 90/385/EEC and 93/42/EEC
10728/16                                                                AV/jk
                                             DGB 2C                                           EN
 ---pagebreak---                                     REGULATION (EU) 2017/…
                OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
                                                  of …
                       on medical devices, amending Directive 2001/83/EC,
                Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009
                  and repealing Council Directives 90/385/EEC and 93/42/EEC
                                      (Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114
and Article 168(4)(c) thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Having regard to the opinion of the European Economic and Social Committee 1,
After consulting the Committee of the Regions,
Acting in accordance with the ordinary legislative procedure 2,
1
        Opinion of 14 February 2013 (OJ C 133, 9.5.2013, p. 52).
2
        Position of the European Parliament of 2 April 2014 (not yet published in the Official
        Journal) and position of the Council at first reading of … (not yet published in the Official
        Journal).
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                                                 DGB 2C                                           EN
 ---pagebreak--- Whereas:
(1)     Council Directive 90/385/EEC 1 and Council Directive 93/42/EEC 2 constitute the Union
        regulatory framework for medical devices, other than in vitro diagnostic medical devices.
        However, a fundamental revision of those Directives is needed to establish a robust,
        transparent, predictable and sustainable regulatory framework for medical devices which
        ensures a high level of safety and health whilst supporting innovation.
1
      Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the
      Member States relating to active implantable medical devices (OJ L 189, 20.7.1990, p. 17).
2
      Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169,
      12.7.1993, p. 1).
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                                              DGB 2C                                          EN
 ---pagebreak--- (2)     This Regulation aims to ensure the smooth functioning of the internal market as regards
        medical devices, taking as a base a high level of protection of health for patients and users,
        and taking into account the small- and medium-sized enterprises that are active in this
        sector. At the same time, this Regulation sets high standards of quality and safety for
        medical devices in order to meet common safety concerns as regards such products. Both
        objectives are being pursued simultaneously and are inseparably linked whilst one not
        being secondary to the other. As regards Article 114 of the Treaty on the Functioning of
        the European Union (TFEU), this Regulation harmonises the rules for the placing on the
        market and putting into service of medical devices and their accessories on the Union
        market thus allowing them to benefit from the principle of free movement of goods. As
        regards Article 168(4)(c) TFEU, this Regulation sets high standards of quality and safety
        for medical devices by ensuring, among other things, that data generated in clinical
        investigations are reliable and robust and that the safety of the subjects participating in a
        clinical investigation is protected.
(3)     This Regulation does not seek to harmonise rules relating to the further making available
        on the market of medical devices after they have already been put into service such as in
        the context of second-hand sales.
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                                               DGB 2C                                              EN
 ---pagebreak--- (4)     Key elements of the existing regulatory approach, such as the supervision of notified
        bodies, conformity assessment procedures, clinical investigations and clinical evaluation,
        vigilance and market surveillance should be significantly reinforced, whilst provisions
        ensuring transparency and traceability regarding medical devices should be introduced, to
        improve health and safety.
(5)     To the extent possible, guidance developed for medical devices at international level, in
        particular in the context of the Global Harmonization Task Force (GHTF) and its
        follow-up initiative, the International Medical Devices Regulators Forum (IMDRF), should
        be taken into account to promote the global convergence of regulations which contributes
        to a high level of safety protection worldwide, and to facilitate trade, in particular in the
        provisions on Unique Device Identification, general safety and performance requirements,
        technical documentation, classification rules, conformity assessment procedures and
        clinical investigations.
(6)     For historical reasons active implantable medical devices, covered by
        Directive 90/385/EEC, and other medical devices, covered by Directive 93/42/EEC, were
        regulated in two separate legal instruments. In the interest of simplification, both
        directives, which have been amended several times, should be replaced by a single
        legislative act applicable to all medical devices other than in vitro diagnostic medical
        devices.
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                                               DGB 2C                                               EN
 ---pagebreak--- (7)     The scope of application of this Regulation should be clearly delimited from other Union
        harmonisation legislation concerning products, such as in vitro diagnostic medical devices,
        medicinal products, cosmetics and food. Therefore, Regulation (EC) No 178/2002 of the
        European Parliament and of the Council 1 should be amended to exclude medical devices
        from its scope.
(8)     It should be the responsibility of the Member States to decide on a case-by-case basis
        whether or not a product falls within the scope of this Regulation. In order to ensure
        consistent qualification decisions in that regard across all Member States, particularly with
        regard to borderline cases, the Commission should be allowed to, on its own initiative or at
        the duly substantiated request of a Member State, having consulted the Medical Device
        Coordination Group ('MDCG'), decide on a case-by-case basis whether or not a specific
        product, category or group of products falls within the scope of this Regulation. When
        deliberating on the regulatory status of products in borderline cases involving medicinal
        products, human tissues and cells, biocidal products or food products, the Commission
        should ensure an appropriate level of consultation of the European Medicines
        Agency (EMA), the European Chemicals Agency and the European Food Safety
        Authority, as relevant.
1
      Regulation (EC) No 178/2002 of the European Parliament and of the Council of
      28 January 2002 laying down the general principles and requirements of food law,
      establishing the European Food Safety Authority and laying down procedures in matters of
      food safety (OJ L 31, 1.2.2002, p. 1).
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                                               DGB 2C                                            EN
 ---pagebreak--- (9)     Since in some cases it is difficult to distinguish between medical devices and cosmetic
        products, the possibility of taking a Union-wide decision regarding the regulatory status of
        a product should also be introduced in Regulation (EC) No 1223/2009 of the European
        Parliament and of the Council 1.
(10)    Products which combine a medicinal product or substance and a medical device are
        regulated either under this Regulation or under Directive 2001/83/EC of the European
        Parliament and of the Council. 2 The two legislative acts should ensure appropriate
        interaction in terms of consultations during pre-market assessment, and of exchange of
        information in the context of vigilance activities involving such combination products. For
        medicinal products that integrate a medical device part, compliance with the general safety
        and performance requirements laid down in this Regulation for the device part should be
        adequately assessed in the context of the marketing authorisation for such medicinal
        products. Directive 2001/83/EC should therefore be amended.
1
      Regulation (EC) No 1223/2009 of the European Parliament and of the Council of
      30 November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59).
2
      Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001
      on the Community code relating to medicinal products for human use (OJ L 311,
      28.11.2001, p. 67).
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                                                DGB 2C                                          EN
 ---pagebreak--- (11)    Union legislation, in particular Regulation (EC) No 1394/2007 of the European Parliament
        and of the Council 1 and Directive 2004/23/EC of the European Parliament and of the
        Council 2, is incomplete in respect of certain products manufactured utilising derivatives of
        tissues or cells of human origin that are non-viable or are rendered non-viable. Such
        products should come under the scope of this Regulation, provided they comply with the
        definition of a medical device or are covered by this Regulation.
(12)    Certain groups of products for which a manufacturer claims only an aesthetic or another
        non-medical purpose but which are similar to medical devices in terms of functioning and
        risks profile should be covered by this Regulation. In order for manufacturers to be able to
        demonstrate the conformity of such products, the Commission should adopt common
        specifications at least with regard to application of risk management and, where necessary,
        clinical evaluation regarding safety. Such common specifications should be developed
        specifically for a group of products without an intended medical purpose and should not be
        used for conformity assessment of the analogous devices with a medical purpose. Devices
        with both a medical and a non-medical intended purpose should fulfil both the
        requirements applicable to devices with, and to devices without, an intended medical
        purpose.
1
      Regulation (EC) No 1394/2007 of the European Parliament and of the Council of
      13 November 2007 on advanced therapy medicinal products and amending
      Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121).
2
      Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on
      setting standards of quality and safety for the donation, procurement, testing, processing,
      preservation, storage and distribution of human tissues and cells (OJ L 102, 7.4.2004, p. 48).
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                                                DGB 2C                                          EN
 ---pagebreak--- (13)    As is the case for products that contain viable tissues or cells of human or animal origin,
        that are explicitly excluded from Directives 90/385/EEC and 93/42/EEC and hence from
        this Regulation, it should be clarified that products that contain or consist of viable
        biological materials or viable organisms of another origin in order to achieve or support the
        intended purpose of those products are not covered by this Regulation either.
(14)    The requirements laid down in Directive 2002/98/EC of the European Parliament and of
        the Council 1 should continue to apply.
(15)    There is scientific uncertainty about the risks and benefits of nanomaterials used for
        devices. In order to ensure a high level of health protection, free movement of goods and
        legal certainty for manufacturers, it is necessary to introduce a uniform definition for
        nanomaterials based on Commission Recommendation 2011/696/EU 2, with the necessary
        flexibility to adapt that definition to scientific and technical progress and subsequent
        regulatory development at Union and international level. In the design and manufacture of
        devices, manufacturers should take special care when using nanoparticles for which there
        is a high or medium potential for internal exposure. Such devices should be subject to the
        most stringent conformity assessment procedures. In preparation of implementing acts
        regulating the practical and uniform application of the corresponding requirements laid
        down in this Regulation, the relevant scientific opinions of the relevant scientific
        committees should be taken into account.
1
      Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003
      setting standards of quality and safety for the collection, testing, processing, storage and
      distribution of human blood and blood components (OJ L 33, 8.2.2003, p. 30).
2
      Commission Recommendation 2011/696/EU of 18 October 2011 on the definition of
      nanomaterial (OJ L 275, 20.10.2011, p. 38).
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                                                 DGB 2C                                           EN
 ---pagebreak--- (16)    Safety aspects addressed by Directive 2014/30/EU of the European Parliament and of the
        Council 1 are an integral part of the general safety and performance requirements laid down
        in this Regulation for devices. Consequently, this Regulation should be considered a
        lex specialis in relation to that Directive.
(17)    This Regulation should include requirements regarding the design and manufacture of
        devices emitting ionizing radiation without affecting the application of Council
        Directive 2013/59/Euratom 2 which pursues other objectives.
(18)    This Regulation should include requirements for devices' design, safety and performance
        characteristics which are developed in such a way as to prevent occupational injuries,
        including protection from radiation.
(19)    It is necessary to clarify that software in its own right, when specifically intended by the
        manufacturer to be used for one or more of the medical purposes set out in the definition of
        a medical device, is qualified as a medical device, while software for general purposes,
        even when used in a healthcare setting, or software intended for life-style and well-being
        purposes are not a medical device. The qualification of software, either as a device or an
        accessory, is independent of the software's location or the type of interconnection between
        the software and a device.
1
      Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014
      on the harmonisation of the laws of the Member States relating to electromagnetic
      compatibility (OJ L 96, 29.3.2014. p. 79).
2
      Council Directive 2013/59/Euratom of 5 December 2013 laying down basic safety standards
      for protection against the dangers arising from exposure to ionising radiation, and repealing
      Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and
      2003/122/Euratom (OJ L 13, 17.1.2014, p. 1).
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                                                 DGB 2C                                           EN
 ---pagebreak--- (20)    The definitions in this Regulation, regarding devices themselves, the making available of
        devices, economic operators, users and specific processes, the conformity assessment,
        clinical investigations and clinical evaluations, post-market surveillance, vigilance and
        market surveillance, standards and other technical specifications, should be aligned with
        well-established practice in the field at Union and international level in order to enhance
        legal certainty.
(21)    It should be made clear that it is essential that devices offered to persons in the Union by
        means of information society services within the meaning of Directive (EU) 2015/1535 of
        the European Parliament and of the Council 1 and devices used in the context of a
        commercial activity to provide a diagnostic or therapeutic service to persons within the
        Union comply with the requirements of this Regulation, where the product in question is
        placed on the market or the service is provided in the Union.
1
      Directive (EU) 2015/1535 of the European Parliament and of the Council of
      9 September 2015 laying down a procedure for the provision of information in the field of
      technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015,
      p. 1).
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                                               DGB 2C                                             EN
 ---pagebreak--- (22)    To recognise the important role of standardisation in the field of medical devices,
        compliance with harmonised standards as defined in Regulation (EU) No 1025/2012 of the
        European Parliament and of the Council 1 should be a means for manufacturers to
        demonstrate conformity with the general safety and performance requirements and other
        legal requirements, such as relating to quality and risk management, laid down in this
        Regulation.
(23)    Directive 98/79/EC of the European Parliament and of the Council 2 allows the
        Commission to adopt common technical specifications for specific categories of in vitro
        diagnostic medical devices. In areas where no harmonised standards exist or where they
        are insufficient, the Commission should be empowered to lay down common specifications
        which provide a means of complying with the general safety and performance
        requirements, and the requirements for clinical investigations and clinical evaluation
        and/or post-market clinical follow-up, laid down in this Regulation.
1
      Regulation (EU) No 1025/2012 of the European Parliament and of the Council of
      25 October 2012 on European standardisation, amending Council Directives 89/686/EEC
      and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC,
      2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of
      the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of
      the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).
2
      Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on
      in vitro diagnostic medical devices (OJ L 331, 7.12.1998, p. 1).
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                                               DGB 2C                                          EN
 ---pagebreak--- (24)    Common specifications ('CS') should be developed after consulting the relevant
        stakeholders and taking account of European and international standards.
(25)    The rules applicable to devices should be aligned, where appropriate, with the New
        Legislative Framework for the Marketing of Products, which consists of
        Regulation (EC) No 765/2008 of the European Parliament and of the Council 1 and
        Decision No 768/2008/EC of the European Parliament and of the Council 2.
(26)    The rules on Union market surveillance and control of products entering the Union market
        laid down in Regulation (EC) No 765/2008 apply to devices covered by this Regulation
        which does not prevent Member States from choosing the competent authorities to carry
        out those tasks.
(27)    It is appropriate to set out clearly the general obligations of the different economic
        operators, including importers and distributors, building on the New Legislative
        Framework for the Marketing of Products, without prejudice to the specific obligations laid
        down in the various parts of this Regulation, to enhance understanding of the requirements
        laid down in this Regulation and thus to improve regulatory compliance by the relevant
        operators.
1
      Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008
      setting out the requirements for accreditation and market surveillance relating to the
      marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008,
      p. 30).
2
      Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on
      a common framework for the marketing of products, and repealing Council
      Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82).
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                                                 DGB 2C                                        EN
 ---pagebreak--- (28)    For the purpose of this Regulation, the activities of distributors should be deemed to
        include acquisition, holding and supplying of devices.
(29)    Several of the obligations on manufacturers, such as clinical evaluation or vigilance
        reporting, that were set out only in the Annexes to Directives 90/385/EEC and 93/42/EEC,
        should be incorporated into the enacting provisions of this Regulation to facilitate its
        application.
(30)    Health institutions should have the possibility of manufacturing, modifying and using
        devices in-house and thereby address, on a non-industrial scale, the specific needs of target
        patient groups which cannot be met at the appropriate level of performance by an
        equivalent device available on the market. In that context, it is appropriate to provide that
        certain rules of this Regulation, as regards medical devices manufactured and used only
        within health institutions, including hospitals as well as institutions, such as laboratories
        and public health institutes that support the healthcare system and/or address patient needs,
        but which do not treat or care for patients directly, should not apply, since the aims of this
        Regulation would still be met in a proportionate manner. It should be noted that the
        concept of 'health institution' does not cover establishments primarily claiming to pursue
        health interests or healthy lifestyles, such as gyms, spas, wellness and fitness centres. As a
        result, the exemption applicable to health institutions does not apply to such
        establishments.
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                                                 DGB 2C                                            EN
 ---pagebreak--- (31)    In view of the fact that natural or legal persons can claim compensation for damage caused
        by a defective device in accordance with applicable Union and national law, it is
        appropriate to require manufacturers to have measures in place to provide sufficient
        financial coverage in respect of their potential liability under Council
        Directive 85/374/EEC 1. Such measures should be proportionate to the risk class, type of
        device and the size of the enterprise. In this context, it is also appropriate to lay down rules
        concerning the facilitation, by a competent authority, of the provision of information to
        persons who may have been injured by a defective device.
(32)    To ensure that devices manufactured in series production continue to be in conformity with
        the requirements of this Regulation and that experience from the use of the devices they
        manufacture is taken into account for the production process, all manufacturers should
        have a quality management system and a post-market surveillance system in place which
        should be proportionate to the risk class and the type of the device in question. In addition,
        in order to minimize risks or prevent incidents related to devices, manufacturers should
        establish a system for risk management and a system for reporting of incidents and field
        safety corrective actions.
(33)    The risk management system should be carefully aligned with and reflected in the clinical
        evaluation for the device, including the clinical risks to be addressed as part of clinical
        investigations, clinical evaluation and post-market clinical follow up. The risk management
        and clinical evaluation processes should be inter-dependent and should be regularly
        updated.
1
      Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws,
      regulations and administrative provisions of the Member States concerning liability for
      defective products (OJ L 210, 7.8.1985, p. 29).
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                                                DGB 2C                                             EN
 ---pagebreak--- (34)    It should be ensured that supervision and control of the manufacture of devices, and the
        post-market surveillance and vigilance activities concerning them, are carried out within
        the manufacturer's organisation by a person responsible for regulatory compliance who
        fulfils minimum conditions of qualification.
(35)    For manufacturers who are not established in the Union, the authorised representative
        plays a pivotal role in ensuring the compliance of the devices produced by those
        manufacturers and in serving as their contact person established in the Union. Given that
        pivotal role, for the purposes of enforcement it is appropriate to make the authorised
        representative legally liable for defective devices in the event that a manufacturer
        established outside the Union has not complied with its general obligations. The liability of
        the authorised representative provided for in this Regulation is without prejudice to the
        provisions of Directive 85/374/EEC, and accordingly the authorised representative should
        be jointly and severally liable with the importer and the manufacturer. The tasks of an
        authorised representative should be defined in a written mandate. Considering the role of
        authorised representatives, the minimum requirements they should meet should be clearly
        defined, including the requirement of having available a person who fulfils minimum
        conditions of qualification which should be similar to those for a manufacturer's person
        responsible for regulatory compliance.
(36)    To ensure legal certainty in respect of the obligations incumbent on economic operators, it
        is necessary to clarify when a distributor, importer or other person is to be considered the
        manufacturer of a device.
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                                               DGB 2C                                            EN
 ---pagebreak--- (37)    Parallel trade in products already placed on the market is a lawful form of trade within the
        internal market on the basis of Article 34 TFEU subject to the limitations arising from the
        need for protection of health and safety and from the need for protection of intellectual
        property rights provided for under Article 36 TFEU. Application of the principle of parallel
        trade is, however, subject to different interpretations in the Member States. The conditions,
        in particular the requirements for relabelling and repackaging, should therefore be
        specified in this Regulation, taking into account the case-law of the Court of Justice 1 in
        other relevant sectors and existing good practice in the field of medical devices.
(38)    The reprocessing and further use of single-use devices should only take place where
        permitted by national law, and while complying with the requirements laid down in this
        Regulation. The Reprocessor of a single-use device should be considered to be the
        manufacturer of the reprocessed device and should assume the obligations incumbent on
        manufacturers under this Regulation. Nevertheless, Member States should have the
        possibility of deciding that the obligations relating to reprocessing and re-use of single-use
        devices within a health institution or by an external reprocessor acting on its behalf may
        differ from the obligations for a manufacturer described in this Regulation. In principle,
        such divergence should only be permitted where reprocessing and reuse of single-use
        devices within a health institution or by an external reprocessor are compliant with CS that
        have been adopted, or, in the absence of such CS, with relevant harmonised standards and
        national provisions. The reprocessing of such devices should ensure an equivalent level of
        safety and performance to that of the corresponding initial single-use device.
1
      Judgment of 28 July 2011 in Orifarm and Paranova, joined cases C-400/09 and C-207/10,
      ECLI:EU:C:2011:519.
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                                               DGB 2C                                             EN
 ---pagebreak--- (39)    Patients who are implanted with a device should be given clear and easily accessible
        essential information allowing the implanted device to be identified and other relevant
        information about the device, including any necessary health risk warnings or precautions
        to be taken, for example indications as to whether or not it is compatible with certain
        diagnostic devices or with scanners used for security controls.
(40)    Devices should, as a general rule, bear the CE marking to indicate their conformity with
        this Regulation so that they can move freely within the Union and be put into service in
        accordance with their intended purpose. Member States should not create obstacles to the
        placing on the market or putting into service of devices that comply with the requirements
        laid down in this Regulation. However, Member States should be allowed to decide
        whether to restrict the use of any specific type of device in relation to aspects that are not
        covered by this Regulation.
(41)    The traceability of devices by means of a Unique Device Identification
        system (UDI system) based on international guidance should significantly enhance the
        effectiveness of the post-market safety-related activities for devices, which is owing to
        improved incident reporting, targeted field safety corrective actions and better monitoring
        by competent authorities. It should also help to reduce medical errors and to fight against
        falsified devices. Use of the UDI system should also improve purchasing and waste
        disposal policies and stock-management by health institutions and other economic
        operators and, where possible, be compatible with other authentication systems already in
        place in those settings.
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                                               DGB 2C                                              EN
 ---pagebreak--- (42)    The UDI system should apply to all devices placed on the market except custom-made
        devices, and be based on internationally recognised principles including definitions that are
        compatible with those used by major trade partners. In order for the UDI system to become
        functional in time for the application of this Regulation detailed rules should be laid down
        in this Regulation.
(43)    Transparency and adequate access to information, appropriately presented for the intended
        user, are essential in the public interest, to protect public health, to empower patients and
        healthcare professionals and to enable them to make informed decisions, to provide a
        sound basis for regulatory decision-making and to build confidence in the regulatory
        system.
(44)    One key aspect in fulfilling the objectives of this Regulation is the creation of a European
        database on medical devices (Eudamed) that should integrate different electronic systems
        to collate and process information regarding devices on the market and the relevant
        economic operators, certain aspects of conformity assessment, notified bodies, certificates,
        clinical investigations, vigilance and market surveillance. The objectives of the database
        are to enhance overall transparency, including through better access to information for the
        public and healthcare professionals, to avoid multiple reporting requirements, to enhance
        coordination between Member States and to streamline and facilitate the flow of
        information between economic operators, notified bodies or sponsors and Member States
        as well as between Member States among themselves and with the Commission. Within
        the internal market, this can be ensured effectively only at Union level and the
        Commission should therefore further develop and manage the European databank on
        medical devices set up by Commission Decision 2010/227/EU 1.
1
      Commission Decision 2010/227/EU of 19 April 2010 on the European Databank for
      Medical Devices (OJ L 102, 23.4.2010, p. 45).
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                                                DGB 2C                                             EN
 ---pagebreak--- (45)    To facilitate the functioning of Eudamed, an internationally recognised medical device
        nomenclature should be available free of charge to manufacturers and other natural or legal
        persons required by this Regulation to use that nomenclature. Furthermore that
        nomenclature should be available, where reasonably practicable, free of charge also to
        other stakeholders.
(46)    Eudamed's electronic systems regarding devices on the market, the relevant economic
        operators and certificates should enable the public to be adequately informed about devices
        on the Union market. The electronic system on clinical investigations should serve as a
        tool for the cooperation between Member States and for enabling sponsors to submit, on a
        voluntary basis, a single application for several Member States and to report serious
        adverse events, device deficiencies and related updates. The electronic system on vigilance
        should enable manufacturers to report serious incidents and other reportable events and to
        support the coordination of the evaluation of such incidents and events by competent
        authorities. The electronic system regarding market surveillance should be a tool for the
        exchange of information between competent authorities.
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                                               DGB 2C                                           EN
 ---pagebreak--- (47)    In respect of data collated and processed through the electronic systems of Eudamed,
        Directive 95/46/EC of the European Parliament and of the Council 1 applies to the
        processing of personal data carried out in the Member States, under the supervision of the
        Member States' competent authorities, in particular the public independent authorities
        designated by the Member States. Regulation (EC) No 45/2001 of the European Parliament
        and of the Council 2 applies to the processing of personal data carried out by the
        Commission within the framework of this Regulation, under the supervision of the
        European Data Protection Supervisor. In accordance with Regulation (EC) No 45/2001, the
        Commission should be designated as the controller of Eudamed and its electronic systems.
(48)    For implantable devices and for class III devices, manufacturers should summarise the
        main safety and performance aspects of the device and the outcome of the clinical
        evaluation in a document that should be publicly available.
(49)    The summary of safety and clinical performance for a device should include in particular
        the place of the device in the context of diagnostic or therapeutic options taking into
        account the clinical evaluation of that device when compared to the diagnostic or
        therapeutic alternatives and the specific conditions under which that device and its
        alternatives can be considered.
1
      Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on
      the protection of individuals with regard to the processing of personal data and on the free
      movement of such data (OJ L 281, 23.11.1995, p. 31).
2
      Regulation (EC) No 45/2001 of the European Parliament and of the Council of
      18 December 2000 on the protection of individuals with regard to the processing of personal
      data by the Community institutions and bodies and on the free movement of such data
      (OJ L 8, 12.1.2001, p. 1).
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                                               DGB 2C                                           EN
 ---pagebreak--- (50)    The proper functioning of notified bodies is crucial for ensuring a high level of health and
        safety protection and citizens' confidence in the system. Designation and monitoring of
        notified bodies by the Member States, in accordance with detailed and strict criteria,
        should therefore be subject to controls at Union level.
(51)    Notified bodies' assessments of manufacturers' technical documentation, in particular
        documentation on clinical evaluation, should be critically evaluated by the authority
        responsible for notified bodies. That evaluation should be part of the risk-based approach
        to the oversight and monitoring activities of notified bodies and should be based on
        sampling of the relevant documentation.
(52)    The position of notified bodies vis-à-vis manufacturers should be strengthened, including
        with regard to their right and duty to carry out unannounced on-site audits and to conduct
        physical or laboratory tests on devices to ensure continuous compliance by manufacturers
        after receipt of the original certification.
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                                                 DGB 2C                                          EN
 ---pagebreak--- (53)    To increase transparency with regard to the oversight of notified bodies by national
        authorities, the authorities responsible for notified bodies should publish information on
        the national measures governing the assessment, designation and monitoring of notified
        bodies. In accordance with good administrative practice, this information should be kept up
        to date by those authorities in particular to reflect relevant, significant or substantive
        changes to the procedures in question.
(54)    The Member State in which a notified body is established should be responsible for
        enforcing the requirements of this Regulation with regard to that notified body.
(55)    In view, in particular, of the responsibility of Member States for the organisation and
        delivery of health services and medical care, they should be allowed to lay down additional
        requirements on notified bodies designated for the conformity assessment of devices and
        established on their territory as far as issues that are not regulated in this Regulation are
        concerned. Any such additional requirements laid down should not affect more specific
        horizontal Union legislation on notified bodies and equal treatment of notified bodies.
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                                                DGB 2C                                              EN
 ---pagebreak--- (56)    For class III implantable devices and class IIb active devices intended to administer and/or
        remove a medicinal product, notified bodies should, except in certain cases, be obliged to
        request expert panels to scrutinise their clinical evaluation assessment report. Competent
        authorities should be informed about devices which have been granted a certificate
        following a conformity assessment procedure involving an expert panel. The consultation
        of expert panels in relation to the clinical evaluation should lead to a harmonised
        evaluation of high risk medical devices by sharing expertise on clinical aspects and
        developing CS on categories of devices that have undergone that consultation process.
(57)    For class III devices and for certain class IIb devices, a manufacturer should be able to
        consult voluntarily an expert panel, prior to that manufacturer's clinical evaluation and/or
        investigation, on its clinical development strategy and on proposals for clinical
        investigations.
(58)    It is necessary, in particular for the purpose of the conformity assessment procedures, to
        maintain the division of devices into four product classes in line with international practice.
        The classification rules, which are based on the vulnerability of the human body, should
        take into account the potential risks associated with the technical design and manufacture
        of the devices. To maintain the same level of safety as provided by Directive 90/385/EEC,
        active implantable devices should be in the highest risk class.
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                                                 DGB 2C                                          EN
 ---pagebreak--- (59)    Rules under the old regime applied to invasive devices do not sufficiently take account of
        the level of invasiveness and potential toxicity of certain devices which are introduced into
        the human body. In order to obtain a suitable risk-based classification of devices that are
        composed of substances or of combinations of substances that are absorbed by or locally
        dispersed in the human body, it is necessary to introduce specific classification rules for
        such devices. The classification rules should take into account the place where the device
        performs its action in or on the human body, where it is introduced or applied, and whether
        a systemic absorption of the substances of which the device is composed, or of the
        products of metabolism in the human body of those substances occurs.
(60)    The conformity assessment procedure for class I devices should be carried out, as a general
        rule, under the sole responsibility of manufacturers in view of the low level of vulnerability
        associated with such devices. For class IIa, class IIb and class III devices, an appropriate
        level of involvement of a notified body should be compulsory.
(61)    The conformity assessment procedures for devices should be further strengthened and
        streamlined whilst the requirements for notified bodies as regards the performance of their
        assessments should be clearly specified to ensure a level playing field.
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                                               DGB 2C                                             EN
 ---pagebreak--- (62)    It is appropriate that certificates of free sale contain information that makes it possible to
        use Eudamed in order to obtain information on the device, in particular with regard to
        whether it is on the market, withdrawn from the market or recalled, and on any certificate
        on its conformity.
(63)    To ensure a high level of safety and performance, demonstration of compliance with the
        general safety and performance requirements laid down in this Regulation should be based
        on clinical data that, for class III devices and implantable devices should, as a general rule,
        be sourced from clinical investigations that have been carried out under the responsibility
        of a sponsor. It should be possible both for the manufacturer and for another natural or
        legal person to be the sponsor taking responsibility for the clinical investigation.
(64)    The rules on clinical investigations should be in line with well-established international
        guidance in this field, such as the international standard ISO 14155:2011 on good clinical
        practice for clinical investigations of medical devices for human subjects, so as to make it
        easier for the results of clinical investigations conducted in the Union to be accepted as
        documentation outside the Union and to make it easier for the results of clinical
        investigations conducted outside the Union in accordance with international guidelines to
        be accepted within the Union. In addition, the rules should be in line with the most recent
        version of the World Medical Association Declaration of Helsinki on Ethical Principles for
        Medical Research Involving Human Subjects.
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                                                  DGB 2C                                           EN
 ---pagebreak--- (65)    It should be left to the Member State where a clinical investigation is to be conducted to
        determine the appropriate authority to be involved in the assessment of the application to
        conduct a clinical investigation and to organise the involvement of ethics committees
        within the timelines for the authorisation of that clinical investigation as set out in this
        Regulation. Such decisions are a matter of internal organisation for each Member State. In
        that context, Member States should ensure the involvement of laypersons, in particular
        patients or patients' organisations. They should also ensure that the necessary expertise is
        available.
(66)    Where, in the course of a clinical investigation, harm caused to a subject leads to the civil
        or criminal liability of the investigator or the sponsor being invoked, the conditions for
        liability in such cases, including issues of causality and the level of damages and sanctions,
        should remain governed by national law.
(67)    An electronic system should be set up at Union level to ensure that every clinical
        investigation is recorded and reported in a publicly accessible database. To protect the right
        to the protection of personal data, recognised by Article 8 of the Charter of Fundamental
        Rights of the European Union, no personal data of subjects participating in a clinical
        investigation should be recorded in the electronic system. To ensure synergies with the
        area of clinical trials on medicinal products, the electronic system on clinical investigations
        should be interoperable with the EU database to be set up for clinical trials on medicinal
        products for human use.
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                                                DGB 2C                                               EN
 ---pagebreak--- (68)    Where a clinical investigation is to be conducted in more than one Member State, the
        sponsor should have the possibility of submitting a single application in order to reduce
        administrative burden. In order to allow for resource-sharing and to ensure consistency
        regarding the assessment of the health and safety-related aspects of the investigational
        device and of the scientific design of that clinical investigation, the procedure for the
        assessment of such single application should be coordinated between the Member States
        under the direction of a coordinating Member State. Such coordinated assessment should
        not include the assessment of intrinsically national, local and ethical aspects of a clinical
        investigation, including informed consent. For an initial period of seven years from the
        date of application of this Regulation, Member States should be able to participate on a
        voluntary basis in the coordinated assessment. After that period, all Member States should
        be obliged to participate in the coordinated assessment. The Commission, based on the
        experience gained from the voluntary coordination between Member States, should draw
        up a report on the application of the relevant provisions regarding the coordinated
        assessment procedure. In the event that the findings of the report are negative, the
        Commission should submit a proposal to extend the time period of participation on a
        voluntary basis in the coordinated assessment procedure.
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                                               DGB 2C                                              EN
 ---pagebreak--- (69)    Sponsors should report certain adverse events and device deficiencies that occur during
        clinical investigations to the Member States in which those clinical investigations are being
        conducted. Member States should have the possibility of terminating or suspending the
        investigations or revoking the authorisation for those investigations, if considered
        necessary to ensure a high level of protection of the subjects participating in a clinical
        investigation. Such information should be communicated to the other Member States.
(70)    The sponsor of a clinical investigation should submit a summary of results of the clinical
        investigation that is easily understandable for the intended user together with the clinical
        investigation report, where applicable, within the timelines laid down in this Regulation.
        Where it is not possible to submit the summary of the results within the defined timelines
        for scientific reasons, the sponsor should justify this and specify when the results will be
        submitted.
(71)    This Regulation should cover clinical investigations intended to gather clinical evidence
        for the purpose of demonstrating conformity of devices and should also lay down basic
        requirements regarding ethical and scientific assessments for other types of clinical
        investigations of medical devices.
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                                               DGB 2C                                              EN
 ---pagebreak--- (72)    Incapacitated subjects, minors, pregnant women and breastfeeding women require specific
        protection measures. However, it should be left to Member States to determine the legally
        designated representatives of incapacitated subjects and minors.
(73)    The principles of replacement, reduction and refinement in the area of animal
        experimentation laid down in the Directive 2010/63/EU of the European Parliament and of
        the Council 1 should be observed. In particular, the unnecessary duplication of tests and
        studies should be avoided.
(74)    Manufacturers should play an active role during the post-market phase by systematically
        and actively gathering information from post-market experience with their devices in order
        to update their technical documentation and cooperate with the national competent
        authorities in charge of vigilance and market surveillance activities. To this end
        manufacturers should establish a comprehensive post-market surveillance system, set up
        under their quality management system and based on a post-market surveillance plan.
        Relevant data and information gathered through post-market surveillance, as well as
        lessons learned from any implemented preventive and/or corrective actions, should be used
        to update any relevant part of technical documentation, such as those relating to risk
        assessment and clinical evaluation, and should also serve the purpose of transparency.
1
      Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010
      on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).
10728/16                                                                 AV/jk                    29
                                              DGB 2C                                            EN
 ---pagebreak--- (75)    In order to better protect health and safety regarding devices on the market, the electronic
        system on vigilance for devices should be made more effective by creating a central portal
        at Union level for reporting serious incidents and field safety corrective actions.
(76)    Member States should take appropriate measures to raise awareness among healthcare
        professionals, users and patients about the importance of reporting incidents. Healthcare
        professionals, users and patients should be encouraged and enabled to report suspected
        serious incidents at national level using harmonised formats. The national competent
        authorities should inform manufacturers of any suspected serious incidents and where a
        manufacturer confirms that such an incident has occurred, the authorities concerned should
        ensure that appropriate follow-up action is taken in order to minimise recurrence of such
        incidents.
(77)    The evaluation of reported serious incidents and field safety corrective actions should be
        conducted at national level but coordination should be ensured where similar incidents
        have occurred or field safety corrective actions have to be carried out in more than one
        Member State, with the objective of sharing resources and ensuring consistency regarding
        the corrective action.
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                                               DGB 2C                                            EN
 ---pagebreak--- (78)    In the context of the investigation of incidents, the competent authorities should take into
        account, where appropriate, the information provided by and views of relevant
        stakeholders, including patient and healthcare professionals' organisations and
        manufacturers' associations.
(79)    The reporting of serious adverse events or device deficiencies during clinical investigations
        and the reporting of serious incidents occurring after a device has been placed on the
        market should be clearly distinguished to avoid double reporting.
(80)    Rules on market surveillance should be included in this Regulation to reinforce the rights
        and obligations of the national competent authorities, to ensure effective coordination of
        their market surveillance activities and to clarify the applicable procedures.
(81)    Any statistically significant increase in the number or severity of incidents that are not
        serious or in expected side-effects that could have a significant impact on the benefit-risk
        analysis and which could lead to unacceptable risks should be reported to the competent
        authorities in order to permit their assessment and the adoption of appropriate measures.
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                                                DGB 2C                                             EN
 ---pagebreak--- (82)    An expert committee, the Medical Device Coordination Group (MDCG), composed of
        persons designated by the Member States based on their role and expertise in the field of
        medical devices including in vitro diagnostic medical devices, should be established to
        fulfil the tasks conferred on it by this Regulation and by Regulation (EU) 2017/… of the
        European Parliament and of the Council 1+, to provide advice to the Commission and to
        assist the Commission and the Member States in ensuring a harmonised implementation of
        this Regulation. The MDCG should be able to establish subgroups in order to have access
        to necessary in-depth technical expertise in the field of medical devices including in vitro
        diagnostic medical devices. When establishing subgroups, appropriate consideration
        should be given to the possibility to involve existing groups at Union level in the field of
        medical devices.
(83)    Expert panels and expert laboratories should be designated by the Commission on the basis
        of their up-to-date clinical, scientific or technical expertise, with the aim of providing
        scientific, technical and clinical assistance to the Commission, the MDCG, manufacturers
        and notified bodies in relation to the implementation of this Regulation. Moreover, expert
        panels should fulfil the tasks of providing an opinion on clinical evaluation assessment
        reports of notified bodies in the case of certain high risk devices.
1
      Regulation (EU) 2017/… of the European Parliament and of the Council of … on in vitro
      diagnostic medical devices and repealing Directive 98/79/EC and Commission
      Decision 2010/227/EU (OJ L …, …, p. …).
+
      OJ: Please insert the serial number of the Regulation in st10729/16 and the publication
      details in the footnote.
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                                                 DGB 2C                                            EN
 ---pagebreak--- (84)    Closer coordination between national competent authorities through information exchange
        and coordinated assessments under the direction of a coordinating authority is essential for
        ensuring a consistently high level of health and safety protection within the internal
        market, in particular in the areas of clinical investigations and vigilance. The principle of
        coordinated exchange and assessment should also apply across other authority activities
        described in this Regulation, such as the designation of notified bodies and should be
        encouraged in the area of market surveillance of devices. Joint working, coordination and
        communication of activities should also lead to more efficient use of resources and
        expertise at national level.
(85)    The Commission should provide scientific, technical and corresponding logistical support
        to coordinating national authorities and ensure that the regulatory system for devices is
        effectively and uniformly implemented at Union level based on sound scientific evidence.
(86)    The Union and, where appropriate, the Member States should actively participate in
        international regulatory cooperation in the field of medical devices to facilitate the
        exchange of safety-related information regarding medical devices and to foster the further
        development of international regulatory guidelines that promote the adoption in other
        jurisdictions of regulations that lead to a level of health and safety protection equivalent to
        that set by this Regulation.
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                                                DGB 2C                                            EN
 ---pagebreak--- (87)    Member States should take all necessary measures to ensure that the provisions of this
        Regulation are implemented, including by laying down effective, proportionate and
        dissuasive penalties for their infringement.
(88)    Whilst this Regulation should not affect the right of Member States to levy fees for
        activities at national level, Member States should, in order to ensure transparency, inform
        the Commission and the other Member States before they decide on the level and structure
        of such fees. In order to further ensure transparency, the structure and level of the fees
        should be publicly available on request.
(89)    This Regulation respects the fundamental rights and observes the principles recognised in
        particular by the Charter of Fundamental Rights of the European Union and in particular
        human dignity, the integrity of the person, the protection of personal data, the freedom of
        art and science, the freedom to conduct business and the right to property. This Regulation
        should be applied by the Member States in accordance with those rights and principles.
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                                               DGB 2C                                              EN
 ---pagebreak--- (90)    The power to adopt delegated acts in accordance with Article 290 TFEU should be
        delegated to the Commission in order to amend certain non-essential provisions of this
        Regulation. It is of particular importance that the Commission carry out appropriate
        consultations during its preparatory work, including at expert level, and that those
        consultations be conducted in accordance with the principles laid down in the
        Interinstitutional Agreement of 13 April 2016 on Better Law-Making 1. In particular, to
        ensure equal participation in the preparation of delegated acts, the European Parliament
        and the Council receive all documents at the same time as Member States' experts, and
        their experts systematically have access to meetings of Commission expert groups dealing
        with preparation of delegated acts.
(91)    In order to ensure uniform conditions for the implementation of this Regulation,
        implementing powers should be conferred on the Commission. Those powers should be
        exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament
        and of the Council 2.
1
      OJ L 123, 12.5.2016, p. 1.
2
      Regulation (EU) No 182/2011 of the European Parliament and of the Council of
      16 February 2011 laying down the rules and general principles concerning mechanisms for
      control by Member States of the Commission's exercise of implementing powers (OJ L 55,
      28.2.2011, p. 13).
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                                               DGB 2C                                          EN
 ---pagebreak--- (92)    The advisory procedure should be used for implementing acts that set out the form and
        presentation of the data elements of manufacturers' summaries of safety and clinical
        performance, and that establish the model for certificates of free sale, given that such
        implementing acts are of a procedural nature and do not directly have an impact on health
        and safety at Union level.
(93)    The Commission should adopt immediately applicable implementing acts where, in duly
        justified cases relating to the extension to the territory of the Union of a national
        derogation from the applicable conformity assessment procedures, imperative grounds of
        urgency so require.
(94)    In order to enable it to designate issuing entities, expert panels and expert laboratories,
        implementing powers should be conferred on the Commission.
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                                                DGB 2C                                             EN
 ---pagebreak--- (95)    To allow economic operators, especially SMEs, notified bodies, Member States and the
        Commission to adapt to the changes introduced by this Regulation and to ensure its proper
        application, it is appropriate to provide for a sufficient transitional period for that
        adaptation and for the organisational arrangements that are to be made. However, certain
        parts of the Regulation that directly affect Member States and the Commission should be
        implemented as soon as possible. It is also particularly important that by the date of
        application of this Regulation, a sufficient number of notified bodies are designated in
        accordance with the new requirements so as to avoid any shortage of medical devices on
        the market. Nonetheless, it is necessary that any designation of a notified body in
        accordance with the requirements of this Regulation prior to the date of its application be
        without prejudice to the validity of the designation of those notified bodies under
        Directives 90/385/EEC and 93/42/EEC and to their capacity to continue issuing valid
        certificates under those two Directives until the date of application of this Regulation.
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                                                DGB 2C                                            EN
 ---pagebreak--- (96)    In order to ensure a smooth transition to the new rules for registration of devices and of
        certificates, the obligation to submit the relevant information to the electronic systems set
        up at Union level pursuant to this Regulation should, in the event that the corresponding
        IT systems are developed according to plan, only become fully effective from 18 months
        after the date of application of this Regulation. During this transitional period, certain
        provisions of Directives 90/385/EEC and 93/42/EEC should remain in force. However, in
        order to avoid multiple registrations, economic operators and notified bodies who register
        in the relevant electronic systems set up at Union level pursuant to this Regulation should
        be considered to be in compliance with the registration requirements adopted by the
        Member States pursuant to those provisions.
(97)    In order to provide for a smooth introduction of the UDI system, the moment of application
        of the obligation to place the UDI carrier on the label of the device should vary from one to
        five years after the date of application of this Regulation depending upon the class of the
        device concerned.
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                                                DGB 2C                                             EN
 ---pagebreak--- (98)    Directives 90/385/EEC and 93/42/EEC should be repealed to ensure that only one set of
        rules applies to the placing of medical devices on the market and the related aspects
        covered by this Regulation. Manufacturers' obligations as regards the making available of
        documentation regarding devices they placed on the market and manufacturers' and
        Member States' obligations as regards vigilance activities for devices placed on the market
        pursuant to those Directives should however continue to apply. While it should be left to
        Member States to decide how to organise vigilance activities, it is desirable for them to
        have the possibility of reporting incidents related to devices placed on the market pursuant
        to the Directives using the same tools as those for reporting on devices placed on the
        market pursuant to this Regulation. It is furthermore appropriate, in order to ensure a
        smooth transition from the old regime to the new regime, to provide that Commission
        Regulation (EU) No 207/2012 1 and Commission Regulation (EU) No 722/2012 2 should
        remain in force and continue to apply unless and until repealed by implementing acts
        adopted by the Commission pursuant to this Regulation.
1
      Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for
      use of medical devices (OJ L 72, 10.3.2012, p. 28).
2
      Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular
      requirements as regards the requirements laid down in Council Directives 90/385/EEC and
      93/42/EEC with respect to active implantable medical devices and medical devices
      manufactured utilising tissues of animal origin (OJ L 212, 9.8.2012, p. 3).
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                                               DGB 2C                                           EN
 ---pagebreak---         Decision 2010/227/EU adopted in implementation of those Directives and
        Directive 98/79/EC should also remain in force and continue to apply until the date when
        Eudamed becomes fully functional. Conversely, no such maintenance in force is required
        for Commission Directives 2003/12/EC 1 and 2005/50/EC 2 and Commission Implementing
        Regulation (EU) No 920/2013 3.
(99)    The requirements of this Regulation should be applicable to all devices placed on the
        market or put into service from the date of application of this Regulation. However, in
        order to provide for a smooth transition it should be possible, for a limited period of time
        from that date, for devices to be placed on the market or put into service by virtue of a
        valid certificate issued pursuant to Directive 90/385/EEC or pursuant to
        Directive 93/42/EEC.
(100)   The European Data Protection Supervisor has given an opinion 4 pursuant to Article 28(2)
        of Regulation (EC) No 45/2001.
1
      Commission Directive 2003/12/EC of 3 February 2003 on the reclassification of breast
      implants in the framework of Directive 93/42/EEC concerning medical devices (OJ L 28,
      4.2.2003, p. 43).
2
      Commission Directive 2005/50/EC of 11 August 2005 on the reclassification of hip, knee
      and shoulder joint replacements in the framework of Council Directive 93/42/EEC
      concerning medical devices (OJ L 210, 12.8.2005, p. 41).
3
      Commission Implementing Regulation (EU) No 920/2013 of 24 September 2013 on the
      designation and the supervision of notified bodies under Council Directive 90/385/EEC on
      active implantable medical devices and Council Directive 93/42/EEC on medical devices
      (OJ L 253, 25.9.2013, p. 8).
4
      OJ C 358, 7.12.2013, p. 10.
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                                               DGB 2C                                             EN
 ---pagebreak--- (101)   Since the objectives of this Regulation, namely to ensure the smooth functioning of the
        internal market as regards medical devices and to ensure high standards of quality and
        safety for medical devices, thus ensuring a high level of protection of health and safety of
        patients, users and other persons, cannot be sufficiently achieved by the Member States but
        can rather, by reason of its scale and effects, be better achieved at Union level, the Union
        may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5
        of the Treaty on European Union. In accordance with the principle of proportionality, as
        set out in that Article, this Regulation does not go beyond what is necessary in order to
        achieve those objectives,
HAVE ADOPTED THIS REGULATION:
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                                                DGB 2C                                            EN
 ---pagebreak---                                             Chapter I
                                    Scope and definitions
                                              Article 1
                                     Subject matter and scope
1.      This Regulation lays down rules concerning the placing on the market, making available
        on the market or putting into service of medical devices for human use and accessories for
        such devices in the Union. This Regulation also applies to clinical investigations
        concerning such medical devices and accessories conducted in the Union.
2.      This Regulation shall also apply, as from the date of application of common specifications
        adopted pursuant to Article 9, to the groups of products without an intended medical
        purpose that are listed in Annex XVI, taking into account the state of the art, and in
        particular existing harmonised standards for analogous devices with a medical purpose,
        based on similar technology. The common specifications for each of the groups of products
        listed in Annex XVI shall address, at least, application of risk management as set out in
        Annex I for the group of products in question and, where necessary, clinical evaluation
        regarding safety.
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                                               DGB 2C                                           EN
 ---pagebreak---         The necessary common specifications shall be adopted by … [date of application of this
        Regulation]. They shall apply as from six months after the date of their entry into force or
        from … [date of application of this Regulation], whichever is the latest.
        Notwithstanding Article 122, Member States' measures regarding the qualification of the
        products covered by Annex XVI as medical devices pursuant to Directive 93/42/EEC shall
        remain valid until the date of application, as referred to in the first subparagraph, of the
        relevant common specifications for that group of products.
        This Regulation also applies to clinical investigations conducted in the Union concerning
        the products referred to in the first subparagraph.
3.      Devices with both a medical and a non-medical intended purpose shall fulfil cumulatively
        the requirements applicable to devices with an intended medical purpose and those
        applicable to devices without an intended medical purpose.
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                                                DGB 2C                                             EN
 ---pagebreak--- 4.      For the purposes of this Regulation, medical devices, accessories for medical devices, and
        products listed in Annex XVI to which this Regulation applies pursuant to paragraph 2
        shall hereinafter be referred to as 'devices'.
5.      Where justified on account of the similarity between a device with an intended medical
        purpose placed on the market and a product without an intended medical purpose in respect
        of their characteristics and risks, the Commission is empowered to adopt delegated acts in
        accordance with Article 115 to amend the list in Annex XVI, by adding new groups of
        products, in order to protect the health and safety of users or other persons or other aspects
        of public health.
6.      This Regulation does not apply to:
        (a)   in vitro diagnostic medical devices covered by Regulation (EU) 2017/… +;
        (b)   medicinal products as defined in point 2 of Article 1 of Directive 2001/83/EC. In
              deciding whether a product falls under Directive 2001/83/EC or under this
              Regulation, particular account shall be taken of the principal mode of action of the
              product;
+
      OJ: Please insert the serial number of the Regulation in st10729/16.
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                                                DGB 2C                                            EN
 ---pagebreak---         (c) advanced therapy medicinal products covered by Regulation (EC) No 1394/2007;
        (d) human blood, blood products, plasma or blood cells of human origin or devices
            which incorporate, when placed on the market or put into service, such blood
            products, plasma or cells, except for devices referred to in paragraph 8 of this
            Article;
        (e) cosmetic products covered by Regulation (EC) No 1223/2009;
        (f) transplants, tissues or cells of animal origin, or their derivatives, or products
            containing or consisting of them; however this Regulation does apply to devices
            manufactured utilising tissues or cells of animal origin, or their derivatives, which
            are non-viable or are rendered non-viable;
        (g) transplants, tissues or cells of human origin, or their derivatives, covered by
            Directive 2004/23/EC, or products containing or consisting of them; however this
            Regulation does apply to devices manufactured utilising derivatives of tissues or
            cells of human origin which are non-viable or are rendered non-viable;
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                                              DGB 2C                                            EN
 ---pagebreak---         (h)   products, other than those referred to in points (d), (f) and (g), that contain or consist
              of viable biological material or viable organisms, including living micro-organisms,
              bacteria, fungi or viruses in order to achieve or support the intended purpose of the
              product;
        (i)   food covered by Regulation (EC) No 178/2002.
7.      Any device which, when placed on the market or put into service, incorporates as an
        integral part an in vitro diagnostic medical device as defined in point 2 of Article 2 of
        Regulation (EU) 2017/… +, shall be governed by this Regulation. The requirements of
        Regulation (EU) 2017/…+ shall apply to the in vitro diagnostic medical device part of the
        device.
8.      Any device which, when placed on the market or put into service, incorporates, as an
        integral part, a substance which, if used separately, would be considered to be a medicinal
        product as defined in point 2 of Article 1 of Directive 2001/83/EC, including a medicinal
        product derived from human blood or human plasma as defined in point 10 of Article 1 of
        that Directive, and that has an action ancillary to that of the device, shall be assessed and
        authorised in accordance with this Regulation.
+
      OJ: Please insert the serial number of the Regulation in st10729/16.
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                                               DGB 2C                                              EN
 ---pagebreak---         However, if the action of that substance is principal and not ancillary to that of the device,
        the integral product shall be governed by Directive 2001/83/EC or
        Regulation (EC) No 726/2004 of the European Parliament and of the Council 1, as
        applicable. In that case, the relevant general safety and performance requirements set out in
        Annex I to this Regulation shall apply as far as the safety and performance of the device
        part are concerned.
9.      Any device which is intended to administer a medicinal product as defined in point 2 of
        Article 1 of Directive 2001/83/EC shall be governed by this Regulation, without prejudice
        to the provisions of that Directive and of Regulation (EC) No 726/2004 with regard to the
        medicinal product.
        However, if the device intended to administer a medicinal product and the medicinal
        product are placed on the market in such a way that they form a single integral product
        which is intended exclusively for use in the given combination and which is not reusable,
        that single integral product shall be governed by Directive 2001/83/EC or
        Regulation (EC) No 726/2004, as applicable. In that case, the relevant general safety and
        performance requirements set out in Annex I to this Regulation shall apply as far as the
        safety and performance of the device part of the single integral product are concerned.
1
      Regulation (EC) No 726/2004 of the European Parliament and of the Council of
      31 March 2004 laying down Community procedures for the authorisation and supervision of
      medicinal products for human and veterinary use and establishing a European Medicines
      Agency (OJ L 136, 30.4.2004, p. 1).
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                                                DGB 2C                                            EN
 ---pagebreak--- 10.     Any device which, when placed on the market or put into service, incorporates, as an
        integral part, non-viable tissues or cells of human origin or their derivatives that have an
        action ancillary to that of the device shall be assessed and authorised in accordance with
        this Regulation. In that case the provisions for donation, procurement and testing laid down
        in Directive 2004/23/EC shall apply.
        However, if the action of those tissues or cells or their derivatives is principal and not
        ancillary to that of the device and the product is not governed by
        Regulation (EC) No 1394/2007, the product shall be governed by Directive 2004/23/EC. In
        that case, the relevant general safety and performance requirements set out in Annex I to
        this Regulation shall apply as far as the safety and performance of the device part are
        concerned.
11.     This Regulation is specific Union legislation within the meaning of Article 2(3) of
        Directive 2014/30/EU.
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                                                DGB 2C                                             EN
 ---pagebreak--- 12.     Devices which are also machinery within the meaning of point (a) of the second
        paragraph of Article 2 of Directive 2006/42/EC of the European Parliament and of the
        Council 1 shall, where a hazard relevant under that Directive exists, also meet the essential
        health and safety requirements set out in Annex I to that Directive to the extent to which
        those requirements are more specific than the general safety and performance requirements
        set out in Chapter II of Annex I to this Regulation.
13.     This Regulation shall not affect the application of Directive 2013/59/Euratom.
14.     This Regulation shall not affect the right of a Member State to restrict the use of any
        specific type of device in relation to aspects not covered by this Regulation.
15.     This Regulation shall not affect national law concerning the organisation, delivery or
        financing of health services and medical care, such as the requirement that certain devices
        may only be supplied on a medical prescription, the requirement that only certain health
        professionals or healthcare institutions may dispense or use certain devices or that their use
        be accompanied by specific professional counselling.
1
      Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on
      machinery, and amending Directive 95/16/EC (OJ L 157, 9.6.2006, p. 24).
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                                                DGB 2C                                           EN
 ---pagebreak--- 16.      Nothing in this Regulation shall restrict the freedom of the press or the freedom of
         expression in the media in so far as those freedoms are guaranteed in the Union and in the
         Member States, in particular under Article 11 of the Charter of Fundamental Rights of the
         European Union.
                                                Article 2
                                              Definitions
For the purposes of this Regulation, the following definitions apply:
(1)      'medical device' means any instrument, apparatus, appliance, software, implant, reagent,
         material or other article intended by the manufacturer to be used, alone or in combination,
         for human beings for one or more of the following specific medical purposes:
         –     diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of
               disease,
         –     diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or
               disability,
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                                                DGB 2C                                           EN
 ---pagebreak---         –      investigation, replacement or modification of the anatomy or of a physiological or
               pathological process or state,
        –      providing information by means of in vitro examination of specimens derived from
               the human body, including organ, blood and tissue donations,
        and which does not achieve its principal intended action by pharmacological,
        immunological or metabolic means, in or on the human body, but which may be assisted in
        its function by such means.
        The following products shall also be deemed to be medical devices:
        –      devices for the control or support of conception;
        –      products specifically intended for the cleaning, disinfection or sterilisation of devices
               as referred to in Article 1(4) and of those referred to in the first subparagraph of this
               point.
(2)     'accessory for a medical device' means an article which, whilst not being itself a medical
        device, is intended by its manufacturer to be used together with one or several particular
        medical device(s) to specifically enable the medical device(s) to be used in accordance
        with its/their intended purpose(s) or to specifically and directly assist the medical
        functionality of the medical device(s) in terms of its/their intended purpose(s);
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                                                DGB 2C                                              EN
 ---pagebreak--- (3)     'custom-made device' means any device specifically made in accordance with a written
        prescription of any person authorised by national law by virtue of that person's professional
        qualifications which gives, under that person's responsibility, specific design
        characteristics, and is intended for the sole use of a particular patient exclusively to meet
        their individual conditions and needs.
        However, mass-produced devices which need to be adapted to meet the specific
        requirements of any professional user and devices which are mass-produced by means of
        industrial manufacturing processes in accordance with the written prescriptions of any
        authorised person shall not be considered to be custom-made devices;
(4)     'active device' means any device, the operation of which depends on a source of energy
        other than that generated by the human body for that purpose, or by gravity, and which acts
        by changing the density of or converting that energy. Devices intended to transmit energy,
        substances or other elements between an active device and the patient, without any
        significant change, shall not be deemed to be active devices.
        Software shall also be deemed to be an active device;
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                                                DGB 2C                                             EN
 ---pagebreak--- (5)     'implantable device' means any device, including those that are partially or wholly
        absorbed, which is intended:
        –      to be totally introduced into the human body, or
        –      to replace an epithelial surface or the surface of the eye,
        by clinical intervention and which is intended to remain in place after the procedure.
        Any device intended to be partially introduced into the human body by clinical
        intervention and intended to remain in place after the procedure for at least 30 days shall
        also be deemed to be an implantable device;
(6)     'invasive device' means any device which, in whole or in part, penetrates inside the body,
        either through a body orifice or through the surface of the body;
(7)     'generic device group' means a set of devices having the same or similar intended purposes
        or a commonality of technology allowing them to be classified in a generic manner not
        reflecting specific characteristics;
(8)     'single-use device' means a device that is intended to be used on one individual during a
        single procedure;
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                                                DGB 2C                                          EN
 ---pagebreak--- (9)     'falsified device' means any device with a false presentation of its identity and/or of its
        source and/or its CE marking certificates or documents relating to CE marking procedures.
        This definition does not include unintentional non-compliance and is without prejudice to
        infringements of intellectual property rights;
(10)    'procedure pack' means a combination of products packaged together and placed on the
        market with the purpose of being used for a specific medical purpose;
(11)    'system' means a combination of products, either packaged together or not, which are
        intended to be inter-connected or combined to achieve a specific medical purpose;
(12)    'intended purpose' means the use for which a device is intended according to the data
        supplied by the manufacturer on the label, in the instructions for use or in promotional or
        sales materials or statements and as specified by the manufacturer in the clinical
        evaluation;
(13)    'label' means the written, printed or graphic information appearing either on the device
        itself, or on the packaging of each unit or on the packaging of multiple devices;
(14)    'instructions for use' means the information provided by the manufacturer to inform the
        user of a device's intended purpose and proper use and of any precautions to be taken;
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                                               DGB 2C                                               EN
 ---pagebreak--- (15)    'Unique Device Identifier' ('UDI') means a series of numeric or alphanumeric characters
        that is created through internationally accepted device identification and coding standards
        and that allows unambiguous identification of specific devices on the market;
(16)    'non-viable' means having no potential for metabolism or multiplication;
(17)    'derivative' means a 'non-cellular substance' extracted from human or animal tissue or cells
        through a manufacturing process. The final substance used for manufacturing of the device
        in this case does not contain any cells or tissues;
(18)    'nanomaterial' means a natural, incidental or manufactured material containing particles in
        an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of
        the particles in the number size distribution, one or more external dimensions is in the size
        range 1-100 nm;
        Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external
        dimensions below 1 nm shall also be deemed to be nanomaterials;
(19)    'particle', for the purposes of the definition of nanomaterial in point (18), means a minute
        piece of matter with defined physical boundaries;
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                                                 DGB 2C                                          EN
 ---pagebreak--- (20)    'agglomerate', for the purposes of the definition of nanomaterial in point (18), means a
        collection of weakly bound particles or aggregates where the resulting external surface area
        is similar to the sum of the surface areas of the individual components;
(21)    'aggregate', for the purposes of the definition of nanomaterial in point (18), means a
        particle comprising of strongly bound or fused particles;
(22)    'performance' means the ability of a device to achieve its intended purpose as stated by the
        manufacturer;
(23)    'risk' means the combination of the probability of occurrence of harm and the severity of
        that harm;
(24)    'benefit-risk determination' means the analysis of all assessments of benefit and risk of
        possible relevance for the use of the device for the intended purpose, when used in
        accordance with the intended purpose given by the manufacturer;
(25)    'compatibility' is the ability of a device, including software, when used together with one or
        more other devices in accordance with its intended purpose, to:
        (a)    perform without losing or compromising the ability to perform as intended, and/or
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                                                 DGB 2C                                          EN
 ---pagebreak---         (b)    integrate and/or operate without the need for modification or adaption of any part of
               the combined devices, and/or
        (c)    be used together without conflict/interference or adverse reaction.
(26)    'interoperability' is the ability of two or more devices, including software, from the same
        manufacturer or from different manufacturers, to:
        (a)    exchange information and use the information that has been exchanged for the
               correct execution of a specified function without changing the content of the data,
               and/or
        (b)    communicate with each other, and/or
        (c)    work together as intended.
(27)    'making available on the market' means any supply of a device, other than an
        investigational device, for distribution, consumption or use on the Union market in the
        course of a commercial activity, whether in return for payment or free of charge;
(28)    'placing on the market' means the first making available of a device, other than an
        investigational device, on the Union market;
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                                                 DGB 2C                                          EN
 ---pagebreak--- (29)    'putting into service' means the stage at which a device, other than an investigational
        device, has been made available to the final user as being ready for use on the Union
        market for the first time for its intended purpose;
(30)    'manufacturer' means a natural or legal person who manufactures or fully refurbishes a
        device or has a device designed, manufactured or fully refurbished, and markets that
        device under its name or trademark;
(31)    'fully refurbishing', for the purposes of the definition of manufacturer, means the complete
        rebuilding of a device already placed on the market or put into service, or the making of a
        new device from used devices, to bring it into conformity with this Regulation, combined
        with the assignment of a new lifetime to the refurbished device;
(32)    'authorised representative' means any natural or legal person established within the Union
        who has received and accepted a written mandate from a manufacturer, located outside the
        Union, to act on the manufacturer's behalf in relation to specified tasks with regard to the
        latter's obligations under this Regulation;
(33)    'importer' means any natural or legal person established within the Union that places a
        device from a third country on the Union market;
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                                                DGB 2C                                           EN
 ---pagebreak--- (34)    'distributor' means any natural or legal person in the supply chain, other than the
        manufacturer or the importer, that makes a device available on the market, up until the
        point of putting into service;
(35)    'economic operator' means a manufacturer, an authorised representative, an importer, a
        distributor or the person referred to in Article 22(1) and 22(3);
(36)    'health institution' means an organisation the primary purpose of which is the care or
        treatment of patients or the promotion of public health;
(37)    'user' means any healthcare professional or lay person who uses a device;
(38)    'lay person' means an individual who does not have formal education in a relevant field of
        healthcare or medical discipline;
(39)    'reprocessing' means a process carried out on a used device in order to allow its safe reuse
        including cleaning, disinfection, sterilisation and related procedures, as well as testing and
        restoring the technical and functional safety of the used device;
(40)    'conformity assessment' means the process demonstrating whether the requirements of this
        Regulation relating to a device have been fulfilled;
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                                                DGB 2C                                            EN
 ---pagebreak--- (41)    'conformity assessment body' means a body that performs third-party conformity
        assessment activities including calibration, testing, certification and inspection;
(42)    'notified body' means a conformity assessment body designated in accordance with this
        Regulation;
(43)    'CE marking of conformity' or 'CE marking' means a marking by which a manufacturer
        indicates that a device is in conformity with the applicable requirements set out in this
        Regulation and other applicable Union harmonisation legislation providing for its affixing;
(44)    'clinical evaluation' means a systematic and planned process to continuously generate,
        collect, analyse and assess the clinical data pertaining to a device in order to verify the
        safety and performance, including clinical benefits, of the device when used as intended by
        the manufacturer;
(45)    'clinical investigation' means any systematic investigation involving one or more human
        subjects, undertaken to assess the safety or performance of a device;
(46)    'investigational device' means a device that is assessed in a clinical investigation;
(47)    'clinical investigation plan' means a document that describes the rationale, objectives,
        design, methodology, monitoring, statistical considerations, organisation and conduct of a
        clinical investigation;
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                                               DGB 2C                                              EN
 ---pagebreak--- (48)    'clinical data' means information concerning safety or performance that is generated from
        the use of a device and is sourced from the following:
        –      clinical investigation(s) of the device concerned,
        –      clinical investigation(s) or other studies reported in scientific literature, of a device
               for which equivalence to the device in question can be demonstrated,
        –      reports published in peer reviewed scientific literature on other clinical experience of
               either the device in question or a device for which equivalence to the device in
               question can be demonstrated,
        –      clinically relevant information coming from post-market surveillance, in particular
               the post-market clinical follow-up;
(49)    'sponsor' means any individual, company, institution or organisation which takes
        responsibility for the initiation, for the management and setting up of the financing of the
        clinical investigation;
(50)    'subject' means an individual who participates in a clinical investigation;
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                                                 DGB 2C                                               EN
 ---pagebreak--- (51)    'clinical evidence' means clinical data and clinical evaluation results pertaining to a device
        of a sufficient amount and quality to allow a qualified assessment of whether the device is
        safe and achieves the intended clinical benefit(s), when used as intended by the
        manufacturer;
(52)    'clinical performance' means the ability of a device, resulting from any direct or indirect
        medical effects which stem from its technical or functional characteristics, including
        diagnostic characteristics, to achieve its intended purpose as claimed by the manufacturer,
        thereby leading to a clinical benefit for patients, when used as intended by the
        manufacturer;
(53)    'clinical benefit' means the positive impact of a device on the health of an individual,
        expressed in terms of a meaningful, measurable, patient-relevant clinical outcome(s),
        including outcome(s) related to diagnosis, or a positive impact on patient management or
        public health;
(54)    'investigator' means an individual responsible for the conduct of a clinical investigation at a
        clinical investigation site;
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                                                DGB 2C                                            EN
 ---pagebreak--- (55)    'informed consent' means a subject's free and voluntary expression of his or her willingness
        to participate in a particular clinical investigation, after having been informed of all aspects
        of the clinical investigation that are relevant to the subject's decision to participate or, in
        the case of minors and of incapacitated subjects, an authorisation or agreement from their
        legally designated representative to include them in the clinical investigation;
(56)    'ethics committee' means an independent body established in a Member State in
        accordance with the law of that Member State and empowered to give opinions for the
        purposes of this Regulation, taking into account the views of laypersons, in particular
        patients or patients' organisations;
(57)    'adverse event' means any untoward medical occurrence, unintended disease or injury or
        any untoward clinical signs, including an abnormal laboratory finding, in subjects, users or
        other persons, in the context of a clinical investigation, whether or not related to the
        investigational device;
(58)    'serious adverse event' means any adverse event that led to any of the following:
        (a)    death,
        (b)    serious deterioration in the health of the subject, that resulted in any of the following:
               (i)   life-threatening illness or injury,
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                                                 DGB 2C                                              EN
 ---pagebreak---               (ii)  permanent impairment of a body structure or a body function,
              (iii) hospitalisation or prolongation of patient hospitalisation,
              (iv) medical or surgical intervention to prevent life-threatening illness or injury or
                    permanent impairment to a body structure or a body function,
              (v)   chronic disease,
        (c)   foetal distress, foetal death or a congenital physical or mental impairment or birth
              defect;
(59)    'device deficiency' means any inadequacy in the identity, quality, durability, reliability,
        safety or performance of an investigational device, including malfunction, use errors or
        inadequacy in information supplied by the manufacturer;
(60)    'post-market surveillance' means all activities carried out by manufacturers in cooperation
        with other economic operators to institute and keep up to date a systematic procedure to
        proactively collect and review experience gained from devices they place on the market,
        make available on the market or put into service for the purpose of identifying any need to
        immediately apply any necessary corrective or preventive actions;
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                                                DGB 2C                                            EN
 ---pagebreak--- (61)    'market surveillance' means the activities carried out and measures taken by competent
        authorities to check and ensure that devices comply with the requirements set out in the
        relevant Union harmonisation legislation and do not endanger health, safety or any other
        aspect of public interest protection;
(62)    'recall' means any measure aimed at achieving the return of a device that has already been
        made available to the end user;
(63)    'withdrawal' means any measure aimed at preventing a device in the supply chain from
        being further made available on the market;
(64)    'incident' means any malfunction or deterioration in the characteristics or performance of a
        device made available on the market, including use-error due to ergonomic features, as
        well as any inadequacy in the information supplied by the manufacturer and any
        undesirable side-effect;
(65)    'serious incident' means any incident that directly or indirectly led, might have led or might
        lead to any of the following:
        (a)    the death of a patient, user or other person,
        (b)    the temporary or permanent serious deterioration of a patient's, user's or other
               person's state of health,
        (c)    a serious public health threat;
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                                                 DGB 2C                                           EN
 ---pagebreak--- (66)    'serious public health threat' means an event which could result in imminent risk of death,
        serious deterioration in a person's state of health, or serious illness, that may require
        prompt remedial action, and that may cause significant morbidity or mortality in humans,
        or that is unusual or unexpected for the given place and time;
(67)    'corrective action' means action taken to eliminate the cause of a potential or actual non-
        conformity or other undesirable situation;
(68)    'field safety corrective action' means corrective action taken by a manufacturer for
        technical or medical reasons to prevent or reduce the risk of a serious incident in relation to
        a device made available on the market;
(69)    'field safety notice' means a communication sent by a manufacturer to users or customers
        in relation to a field safety corrective action;
(70)    'harmonised standard' means a European standard as defined in point (1)(c) of Article 2 of
        Regulation (EU) No 1025/2012;
(71)    'common specifications' (CS) means a set of technical and/or clinical requirements, other
        than a standard, that provides a means of complying with the legal obligations applicable
        to a device, process or system.
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                                                 DGB 2C                                           EN
 ---pagebreak---                                                 Article 3
                                    Amendment of certain definitions
The Commission is empowered to adopt delegated acts in accordance with Article 115 in order to
amend the definition of nanomaterial set out in point (18) and the related definitions in points (19),
(20) and (21) of Article 2 in the light of technical and scientific progress and taking into account
definitions agreed at Union and international level.
                                                Article 4
                                     Regulatory status of products
1.       Without prejudice to Article 2(2) of Directive 2001/83/EC, upon a duly substantiated
         request of a Member State, the Commission shall, after consulting the Medical Device
         Coordination Group established under Article 103 of this Regulation ('MDCG'), by means
         of implementing acts, determine whether or not a specific product, or category or group of
         products, falls within the definitions of 'medical device' or 'accessory for a medical device'.
         Those implementing acts shall be adopted in accordance with the examination procedure
         referred to in Article 114(3) of this Regulation.
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                                                 DGB 2C                                            EN
 ---pagebreak--- 2.      The Commission may also, on its own initiative, after consulting the MDCG, decide, by
        means of implementing acts, on the issues referred to in paragraph 1 of this Article. Those
        implementing acts shall be adopted in accordance with the examination procedure referred
        to in Article 114(3).
3.      The Commission shall ensure that Member States share expertise in the fields of medical
        devices, in vitro diagnostic medical devices, medicinal products, human tissues and cells,
        cosmetics, biocides, food and, if necessary, other products, in order to determine the
        appropriate regulatory status of a product, or category or group of products.
4.      When deliberating on the possible regulatory status as a device of products involving
        medicinal products, human tissues and cells, biocides or food products, the Commission
        shall ensure an appropriate level of consultation of the European Medicines
        Agency (EMA), the European Chemicals Agency (ECHA) and the European Food Safety
        Authority (EFSA), as relevant.
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                                              DGB 2C                                            EN
 ---pagebreak---                                            Chapter II
                            Making available on the market
                          and putting into service of devices,
                obligations of economic operators, reprocessing,
                              CE marking, free movement
                                              Article 5
                           Placing on the market and putting into service
1.      A device may be placed on the market or put into service only if it complies with this
        Regulation when duly supplied and properly installed, maintained and used in accordance
        with its intended purpose.
2.      A device shall meet the general safety and performance requirements set out in Annex I
        which apply to it, taking into account its intended purpose.
3.      Demonstration of conformity with the general safety and performance requirements shall
        include a clinical evaluation in accordance with Article 61.
4.      Devices that are manufactured and used within health institutions shall be considered as
        having been put into service.
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                                               DGB 2C                                          EN
 ---pagebreak--- 5.      With the exception of the relevant general safety and performance requirements set out in
        Annex I, the requirements of this Regulation shall not apply to devices, manufactured and
        used only within health institutions established in the Union, provided that all of the
        following conditions are met:
        (a)   the devices are not transferred to another legal entity,
        (b)   manufacture and use of the devices occur under appropriate quality management
              systems,
        (c)   the health institution justifies in its documentation that the target patient group's
              specific needs cannot be met, or cannot be met at the appropriate level of
              performance by an equivalent device available on the market,
        (d)   the health institution provides information upon request on the use of such devices to
              its competent authority, which shall include a justification of their manufacturing,
              modification and use;
        (e)   the health institution draws up a declaration, that it shall make publicly available,
              including:
              (i)   the name and address of the manufacturing health institution;
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                                                 DGB 2C                                             EN
 ---pagebreak---                (ii)  the details necessary to identify the devices;
               (iii) a declaration that the devices meet the general safety and performance
                     requirements set out in Annex I to this Regulation and, where applicable,
                     information on which requirements are not fully met with a reasoned
                     justification therefor,
        (f)    the health institution draws up documentation that makes it possible to have an
               understanding of the manufacturing facility, the manufacturing process, the design
               and performance data of the devices, including the intended purpose, and that is
               sufficiently detailed to enable the competent authority to ascertain that the general
               safety and performance requirements set out in Annex I to this Regulation are met;
        (g)   the health institution takes all necessary measures to ensure that all devices are
              manufactured in accordance with the documentation referred to in point (f), and
        (h)   the health institution reviews experience gained from clinical use of the devices and
              takes all necessary corrective actions.
        Member States may require that such health institutions submit to the competent authority
        any further relevant information about such devices which have been manufactured and
        used on their territory. Member States shall retain the right to restrict the manufacture and
        the use of any specific type of such devices and shall be permitted access to inspect the
        activities of the health institutions.
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                                                DGB 2C                                            EN
 ---pagebreak---         This paragraph shall not apply to devices which are manufactured on an industrial scale.
6.      In order to ensure the uniform application of Annex I, the Commission may adopt
        implementing acts to the extent necessary to resolve issues of divergent interpretation and
        of practical application. Those implementing acts shall be adopted in accordance with the
        examination procedure referred to in Article 114(3).
                                              Article 6
                                           Distance sales
1.      A device offered by means of information society services, as defined in point (b) of
        Article 1(1) of Directive (EU) 2015/1535, to a natural or legal person established in the
        Union shall comply with this Regulation.
2.      Without prejudice to national law regarding the exercise of the medical profession, a
        device that is not placed on the market but used in the context of a commercial activity,
        whether in return for payment or free of charge, for the provision of a diagnostic or
        therapeutic service offered by means of information society services as defined in point (b)
        of Article 1(1) of Directive (EU) 2015/1535 or by other means of communication, directly
        or through intermediaries, to a natural or legal person established in the Union shall
        comply with this Regulation.
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                                              DGB 2C                                            EN
 ---pagebreak--- 3.        Upon request by a competent authority, any natural or legal person offering a device in
          accordance with paragraph 1 or providing a service in accordance with paragraph 2 shall
          make available a copy of the EU declaration of conformity of the device concerned.
4.        A Member State may, on grounds of protection of public health, require a provider of
          information society services, as defined in point (b) of Article 1(1) of
          Directive (EU) 2015/1535, to cease its activity.
                                                Article 7
                                                 Claims
In the labelling, instructions for use, making available, putting into service and advertising of
devices, it shall be prohibited to use text, names, trademarks, pictures and figurative or other signs
that may mislead the user or the patient with regard to the device's intended purpose, safety and
performance by:
(a)       ascribing functions and properties to the device which the device does not have;
(b)       creating a false impression regarding treatment or diagnosis, functions or properties which
          the device does not have;
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                                                DGB 2C                                             EN
 ---pagebreak--- (c)     failing to inform the user or the patient of a likely risk associated with the use of the device
        in line with its intended purpose;
(d)     suggesting uses for the device other than those stated to form part of the intended purpose
        for which the conformity assessment was carried out.
                                               Article 8
                                    Use of harmonised standards
1.      Devices which are in conformity with the relevant harmonised standards, or the relevant
        parts of those standards, the references of which have been published in the Official
        Journal of the European Union, shall be presumed to be in conformity with the
        requirements of this Regulation covered by those standards or parts thereof.
        The first subparagraph shall also apply to system or process requirements to be fulfilled in
        accordance with this Regulation by economic operators or sponsors, including those
        relating to quality management systems, risk management, post-market surveillance
        systems, clinical investigations, clinical evaluation or post-market clinical
        follow-up ('PMCF').
        References in this Regulation to harmonised standards shall be understood as meaning
        harmonised standards the references of which have been published in the Official Journal
        of the European Union.
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                                                DGB 2C                                             EN
 ---pagebreak--- 2.      References in this Regulation to harmonised standards shall also include the monographs
        of the European Pharmacopoeia adopted in accordance with the Convention on the
        Elaboration of a European Pharmacopoeia, in particular on surgical sutures and on
        interaction between medicinal products and materials used in devices containing such
        medicinal products, provided that references to those monographs have been published in
        the Official Journal of the European Union.
                                               Article 9
                                        Common specifications
1.      Without prejudice to Article 1(2) and 17(5) and the deadline laid down in those provisions,
        where no harmonised standards exist or where relevant harmonised standards are not
        sufficient, or where there is a need to address public health concerns, the Commission,
        after having consulted the MDCG, may, by means of implementing acts, adopt common
        specifications (CS) in respect of the general safety and performance requirements set out in
        Annex I, the technical documentation set out in Annexes II and III, the clinical evaluation
        and post-market clinical follow-up set out in Annex XIV or the requirements regarding
        clinical investigation set out in Annex XV. Those implementing acts shall be adopted in
        accordance with the examination procedure referred to in Article 114(3).
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                                               DGB 2C                                           EN
 ---pagebreak--- 2.      Devices which are in conformity with the CS referred to in paragraph 1 shall be presumed
        to be in conformity with the requirements of this Regulation covered by those CS or the
        relevant parts of those CS.
3.      Manufacturers shall comply with the CS referred to in paragraph 1 unless they can duly
        justify that they have adopted solutions that ensure a level of safety and performance that is
        at least equivalent thereto.
4.      Notwithstanding paragraph 3, manufacturers of products listed in Annex XVI shall comply
        with the relevant CS for those products.
                                              Article 10
                                General obligations of manufacturers
1.      When placing their devices on the market or putting them into service, manufacturers shall
        ensure that they have been designed and manufactured in accordance with the requirements
        of this Regulation.
2.      Manufacturers shall establish, document, implement and maintain a system for risk
        management as described in Section 3 of Annex I.
3.      Manufacturers shall conduct a clinical evaluation in accordance with the requirements set
        out in Article 61 and Annex XIV, including a PMCF.
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                                               DGB 2C                                           EN
 ---pagebreak--- 4.      Manufacturers of devices other than custom-made devices shall draw up and keep up to
        date technical documentation for those devices. The technical documentation shall be such
        as to allow the conformity of the device with the requirements of this Regulation to be
        assessed. The technical documentation shall include the elements set out in Annexes II
        and III.
        The Commission is empowered to adopt delegated acts in accordance with Article 115
        amending, in the light of technical progress, the Annexes II and III.
5.      Manufacturers of custom-made devices shall draw up, keep up to date and keep available
        for competent authorities documentation in accordance with Section 2 of Annex XIII.
6.      Where compliance with the applicable requirements has been demonstrated following the
        applicable conformity assessment procedure, manufacturers of devices, other than
        custom-made or investigational devices, shall draw up an EU declaration of conformity in
        accordance with Article 19, and affix the CE marking of conformity in accordance with
        Article 20.
7.      Manufacturers shall comply with the obligations relating to the UDI system referred to in
        Article 27 and with the registration obligations referred to in Articles 29 and 31.
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                                              DGB 2C                                            EN
 ---pagebreak--- 8.      Manufacturers shall keep the technical documentation, the EU declaration of conformity
        and, if applicable, a copy of any relevant certificate, including any amendments and
        supplements, issued in accordance with Article 56, available for the competent authorities
        for a period of at least ten years after the last device covered by the EU declaration of
        conformity has been placed on the market. In the case of implantable devices, the period
        shall be at least 15 years after the last device has been placed on the market.
        Upon request by a competent authority, the manufacturer shall, as indicated therein,
        provide that technical documentation in its entirety or a summary thereof.
        A manufacturer with a registered place of business outside the Union shall, in order to
        allow its authorised representative to fulfil the tasks mentioned in Article 11(3), ensure that
        the authorised representative has the necessary documentation permanently available.
9.      Manufacturers shall ensure that procedures are in place to keep series production in
        conformity with the requirements of this Regulation. Changes in device design or
        characteristics and changes in the harmonised standards or CS by reference to which the
        conformity of a device is declared shall be adequately taken into account in a timely
        manner. Manufacturers of devices, other than investigational devices, shall establish,
        document, implement, maintain, keep up to date and continually improve a quality
        management system that shall ensure compliance with this Regulation in the most effective
        manner and in a manner that is proportionate to the risk class and the type of device.
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                                                 DGB 2C                                           EN
 ---pagebreak---         The quality management system shall cover all parts and elements of a manufacturer's
        organisation dealing with the quality of processes, procedures and devices. It shall govern
        the structure, responsibilities, procedures, processes and management resources required to
        implement the principles and actions necessary to achieve compliance with the provisions
        of this Regulation.
        The quality management system shall address at least the following aspects:
        (a)    a strategy for regulatory compliance, including compliance with conformity
               assessment procedures and procedures for management of modifications to the
               devices covered by the system;
        (b)    identification of applicable general safety and performance requirements and
               exploration of options to address those requirements;
        (c)    responsibility of the management;
        (d)    resource management, including selection and control of suppliers and
               sub-contractors;
        (e)    risk management as set out in in Section 3 of Annex I;
        (f)    clinical evaluation in accordance with Article 61 and Annex XIV, including PMCF;
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                                               DGB 2C                                           EN
 ---pagebreak---         (g)  product realisation, including planning, design, development, production and service
             provision;
        (h)  verification of the UDI assignments made in accordance with Article 27(3) to all
             relevant devices and ensuring consistency and validity of information provided in
             accordance with Article 29;
        (i)  setting-up, implementation and maintenance of a post-market surveillance system, in
             accordance with Article 83;
        (j)  handling communication with competent authorities, notified bodies, other economic
             operators, customers and/or other stakeholders;
        (k)  processes for reporting of serious incidents and field safety corrective actions in the
             context of vigilance;
        (l)  management of corrective and preventive actions and verification of their
             effectiveness;
        (m) processes for monitoring and measurement of output, data analysis and product
             improvement.
10.     Manufacturers of devices shall implement and keep up to date the post-market surveillance
        system in accordance with Article 83.
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                                             DGB 2C                                              EN
 ---pagebreak--- 11.     Manufacturers shall ensure that the device is accompanied by the information set out in
        Section 23 of Annex I in an official Union language(s) determined by the Member State in
        which the device is made available to the user or patient. The particulars on the label shall
        be indelible, easily legible, clearly comprehensible to the intended user or patient.
12.     Manufacturers who consider or have reason to believe that a device which they have
        placed on the market or put into service is not in conformity with this Regulation shall
        immediately take the necessary corrective action to bring that device into conformity, to
        withdraw it or to recall it, as appropriate. They shall inform the distributors of the device in
        question and, where applicable, the authorised representative and importers accordingly.
        Where the device presents a serious risk, manufacturers shall immediately inform the
        competent authorities of the Member States in which they made the device available and,
        where applicable, the notified body that issued a certificate for the device in accordance
        with Article 56, in particular, of the non-compliance and of any corrective action taken.
13.     Manufacturers shall have a system for recording and reporting of incidents and field safety
        corrective actions as described in Articles 87 and 88.
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                                                DGB 2C                                             EN
 ---pagebreak--- 14.     Manufacturers shall, upon request by a competent authority, provide it with all the
        information and documentation necessary to demonstrate the conformity of the device, in
        an official Union language determined by the Member State concerned. The competent
        authority of the Member State in which the manufacturer has its registered place of
        business may require that the manufacturer provide samples of the device free of charge or,
        where that is impracticable, grant access to the device. Manufacturers shall cooperate with
        a competent authority, at its request, on any corrective action taken to eliminate or, if that
        is not possible, mitigate the risks posed by devices which they have placed on the market
        or put into service.
        If the manufacturer fails to cooperate or the information and documentation provided is
        incomplete or incorrect, the competent authority may, in order to ensure the protection of
        public health and patient safety, take all appropriate measures to prohibit or restrict the
        device's being made available on its national market, to withdraw the device from that
        market or to recall it until the manufacturer cooperates or provides complete and correct
        information.
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                                               DGB 2C                                              EN
 ---pagebreak---         If a competent authority considers or has reason to believe that a device has caused
        damage, it shall, upon request, facilitate the provision of the information and
        documentation referred to in the first subparagraph to the potentially injured patient or user
        and, as appropriate, the patient's or user's successor in title, the patient's or user's health
        insurance company or other third parties affected by the damage caused to the patient or
        user, without prejudice to data protection rules and, unless there is an overriding public
        interest in disclosure, without prejudice to the protection of intellectual property rights.
        The competent authority need not comply with the obligation laid down in the third
        subparagraph where disclosure of the information and documentation referred to in the first
        subparagraph is ordinarily dealt with in the context of legal proceedings.
15.     Where manufacturers have their devices designed or manufactured by another legal or
        natural person the information on the identity of that person shall be part of the information
        to be submitted in accordance with Article 30(1).
16.     Natural or legal persons may claim compensation for damage caused by a defective device
        in accordance with applicable Union and national law.
        Manufacturers shall, in a manner that is proportionate to the risk class, type of device and
        the size of the enterprise, have measures in place to provide sufficient financial coverage in
        respect of their potential liability under Directive 85/374/EEC, without prejudice to more
        protective measures under national law.
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                                                DGB 2C                                                EN
 ---pagebreak---                                               Article 11
                                       Authorised representative
1.      Where the manufacturer of a device is not established in a Member State, the device may
        only be placed on the Union market if the manufacturer designates a sole authorised
        representative.
2.      The designation shall constitute the authorised representative's mandate, it shall be valid
        only when accepted in writing by the authorised representative and shall be effective at
        least for all devices of the same generic device group.
3.      The authorised representative shall perform the tasks specified in the mandate agreed
        between it and the manufacturer. The authorised representative shall provide a copy of the
        mandate to the competent authority, upon request.
        The mandate shall require, and the manufacturer shall enable, the authorised representative
        to perform at least the following tasks in relation to the devices that it covers:
        (a)    verify that the EU declaration of conformity and technical documentation have been
               drawn up and, where applicable, that an appropriate conformity assessment
               procedure has been carried out by the manufacturer;
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                                               DGB 2C                                            EN
 ---pagebreak---         (b) keep available a copy of the technical documentation, the EU declaration of
            conformity and, if applicable, a copy of the relevant certificate, including any
            amendments and supplements, issued in accordance with Article 56, at the disposal
            of competent authorities for the period referred to in Article 10(8);
        (c) comply with the registration obligations laid down in Article 31 and verify that the
            manufacturer has complied with the registration obligations laid down in Articles 27
            and 29;
        (d) in response to a request from a competent authority, provide that competent authority
            with all the information and documentation necessary to demonstrate the conformity
            of a device, in an official Union language determined by the Member State
            concerned;
        (e) forward to the manufacturer any request by a competent authority of the
            Member State in which the authorised representative has its registered place of
            business for samples, or access to a device and verify that the competent authority
            receives the samples or is given access to the device;
        (f) cooperate with the competent authorities on any preventive or corrective action taken
            to eliminate or, if that is not possible, mitigate the risks posed by devices;
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                                              DGB 2C                                          EN
 ---pagebreak---         (g)   immediately inform the manufacturer about complaints and reports from healthcare
              professionals, patients and users about suspected incidents related to a device for
              which they have been designated;
        (h)   terminate the mandate if the manufacturer acts contrary to its obligations under this
              Regulation.
4.      The mandate referred to in paragraph 3 of this Article shall not delegate the manufacturer's
        obligations laid down in Article 10(1), (2), (3), (4), (6), (7), (9), (10), (11) and (12).
5.      Without prejudice to paragraph 4 of this Article, where the manufacturer is not established
        in a Member State and has not complied with the obligations laid down in Article 10, the
        authorised representative shall be legally liable for defective devices on the same basis as,
        and jointly and severally with, the manufacturer.
6.      An authorised representative who terminates its mandate on the ground referred to in
        point (h) of paragraph 3 shall immediately inform the competent authority of the
        Member State in which it is established and, where applicable, the notified body that was
        involved in the conformity assessment for the device of the termination of the mandate and
        the reasons therefor.
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                                              DGB 2C                                               EN
 ---pagebreak--- 7.      Any reference in this Regulation to the competent authority of the Member State in which
        the manufacturer has its registered place of business shall be understood as a reference to
        the competent authority of the Member State in which the authorised representative,
        designated by a manufacturer referred to in paragraph 1, has its registered place of
        business.
                                             Article 12
                                Change of authorised representative
The detailed arrangements for a change of authorised representative shall be clearly defined in an
agreement between the manufacturer, where practicable the outgoing authorised representative, and
the incoming authorised representative. That agreement shall address at least the following aspects:
(a)     the date of termination of the mandate of the outgoing authorised representative and date of
        beginning of the mandate of the incoming authorised representative;
(b)     the date until which the outgoing authorised representative may be indicated in the
        information supplied by the manufacturer, including any promotional material;
(c)     the transfer of documents, including confidentiality aspects and property rights;
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                                              DGB 2C                                            EN
 ---pagebreak--- (d)     the obligation of the outgoing authorised representative after the end of the mandate to
        forward to the manufacturer or incoming authorised representative any complaints or
        reports from healthcare professionals, patients or users about suspected incidents related to
        a device for which it had been designated as authorised representative.
                                              Article 13
                                  General obligations of importers
1.      Importers shall place on the Union market only devices that are in conformity with this
        Regulation.
2.      In order to place a device on the market, importers shall verify that:
        (a)   the device has been CE marked and that the EU declaration of conformity of the
              device has been drawn up;
        (b)   a manufacturer is identified and that an authorised representative in accordance with
              Article 11 has been designated by the manufacturer;
        (c)   the device is labelled in accordance with this Regulation and accompanied by the
              required instructions for use;
        (d)   where applicable, a UDI has been assigned by the manufacturer in accordance with
              Article 27.
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                                               DGB 2C                                           EN
 ---pagebreak---         Where an importer considers or has reason to believe that a device is not in conformity
        with the requirements of this Regulation, it shall not place the device on the market until it
        has been brought into conformity and shall inform the manufacturer and the manufacturer's
        authorised representative. Where the importer considers or has reason to believe that the
        device presents a serious risk or is a falsified device, it shall also inform the competent
        authority of the Member State in which the importer is established.
3.      Importers shall indicate on the device or on its packaging or in a document accompanying
        the device their name, registered trade name or registered trade mark, their registered place
        of business and the address at which they can be contacted, so that their location can be
        established. They shall ensure that any additional label does not obscure any information
        on the label provided by the manufacturer.
4.      Importers shall verify that the device is registered in the electronic system in accordance
        with Article 29. Importers shall add their details to the registration in accordance with
        Article 31.
5.      Importers shall ensure that, while a device is under their responsibility, storage or transport
        conditions do not jeopardise its compliance with the general safety and performance
        requirements set out in Annex I and shall comply with the conditions set by the
        manufacturer, where available.
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                                                DGB 2C                                             EN
 ---pagebreak--- 6.      Importers shall keep a register of complaints, of non-conforming devices and of recalls and
        withdrawals, and provide the manufacturer, authorised representative and distributors with
        any information requested by them, in order to allow them to investigate complaints.
7.      Importers who consider or have reason to believe that a device which they have placed on
        the market is not in conformity with this Regulation shall immediately inform the
        manufacturer and its authorised representative. Importers shall co-operate with the
        manufacturer, the manufacturer's authorised representative and the competent authorities to
        ensure that the necessary corrective action to bring that device into conformity, to
        withdraw or recall it is taken. Where the device presents a serious risk, they shall also
        immediately inform the competent authorities of the Member States in which they made
        the device available and, if applicable, the notified body that issued a certificate in
        accordance with Article 56 for the device in question, giving details, in particular, of the
        non-compliance and of any corrective action taken.
8.      Importers who have received complaints or reports from healthcare professionals, patients
        or users about suspected incidents related to a device which they have placed on the market
        shall immediately forward this information to the manufacturer and its authorised
        representative.
9.      Importers shall, for the period referred to in Article 10(8), keep a copy of the
        EU declaration of conformity and, if applicable, a copy of any relevant certificate,
        including any amendments and supplements, issued in accordance with Article 56.
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                                               DGB 2C                                             EN
 ---pagebreak--- 10.     Importers shall cooperate with competent authorities, at the latters' request, on any action
        taken to eliminate or, if that is not possible, mitigate the risks posed by devices which they
        have placed on the market. Importers, upon request by a competent authority of the
        Member State in which the importer has its registered place of business, shall provide
        samples of the device free of charge or, where that is impracticable, grant access to the
        device.
                                                Article 14
                                  General obligations of distributors
1.      When making a device available on the market, distributors shall, in the context of their
        activities, act with due care in relation to the requirements applicable.
2.      Before making a device available on the market, distributors shall verify that all of the
        following requirements are met:
        (a)   the device has been CE marked and that the EU declaration of conformity of the
              device has been drawn up;
        (b)   the device is accompanied by the information to be supplied by the manufacturer in
              accordance with Article 10(11);
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                                                 DGB 2C                                           EN
 ---pagebreak---         (c)    for imported devices, the importer has complied with the requirements set out in
               Article 13(3);
        (d)    that, where applicable, a UDI has been assigned by the manufacturer.
        In order to meet the requirements referred to in points (a), (b) and (d) of the first
        subparagraph the distributor may apply a sampling method that is representative of the
        devices supplied by that distributor.
        Where a distributor considers or has reason to believe that a device is not in conformity
        with the requirements of this Regulation, it shall not make the device available on the
        market until it has been brought into conformity, and shall inform the manufacturer and,
        where applicable, the manufacturer's authorised representative, and the importer. Where
        the distributor considers or has reason to believe that the device presents a serious risk or is
        a falsified device, it shall also inform the competent authority of the Member State in
        which it is established.
3.      Distributors shall ensure that, while the device is under their responsibility, storage or
        transport conditions comply with the conditions set by the manufacturer.
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                                                DGB 2C                                             EN
 ---pagebreak--- 4.      Distributors that consider or have reason to believe that a device which they have made
        available on the market is not in conformity with this Regulation shall immediately inform
        the manufacturer and, where applicable, the manufacturer's authorised representative and
        the importer. Distributors shall co-operate with the manufacturer and, where applicable, the
        manufacturer's authorised representative, and the importer, and with competent authorities
        to ensure that the necessary corrective action to bring that device into conformity, to
        withdraw or to recall it, as appropriate, is taken. Where the distributor considers or has
        reason to believe that the device presents a serious risk, it shall also immediately inform
        the competent authorities of the Member States in which it made the device available,
        giving details, in particular, of the non-compliance and of any corrective action taken.
5.      Distributors that have received complaints or reports from healthcare professionals,
        patients or users about suspected incidents related to a device they have made available,
        shall immediately forward this information to the manufacturer and, where applicable, the
        manufacturer's authorised representative, and the importer. They shall keep a register of
        complaints, of non-conforming devices and of recalls and withdrawals, and keep the
        manufacturer and, where available, the authorised representative and the importer informed
        of such monitoring and provide them with any information upon their request.
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                                                DGB 2C                                            EN
 ---pagebreak--- 6.      Distributors shall, upon request by a competent authority, provide it with all the
        information and documentation that is at their disposal and is necessary to demonstrate the
        conformity of a device.
        Distributors shall be considered to have fulfilled the obligation referred to in the first
        subparagraph when the manufacturer or, where applicable, the authorised representative
        for the device in question provides the required information. Distributors shall cooperate
        with competent authorities, at their request, on any action taken to eliminate the risks posed
        by devices which they have made available on the market. Distributors, upon request by a
        competent authority, shall provide free samples of the device or, where that is
        impracticable, grant access to the device.
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                                               DGB 2C                                              EN
 ---pagebreak---                                                Article 15
                            Person responsible for regulatory compliance
1.      Manufacturers shall have available within their organisation at least one person responsible
        for regulatory compliance who possesses the requisite expertise in the field of medical
        devices. The requisite expertise shall be demonstrated by either of the following
        qualifications:
        (a)   a diploma, certificate or other evidence of formal qualification, awarded on
              completion of a university degree or of a course of study recognised as equivalent by
              the Member State concerned, in law, medicine, pharmacy, engineering or another
              relevant scientific discipline, and at least one year of professional experience in
              regulatory affairs or in quality management systems relating to medical devices;
        (b)   four years of professional experience in regulatory affairs or in quality management
              systems relating to medical devices.
        Without prejudice to national provisions regarding professional qualifications,
        manufacturers of custom-made devices may demonstrate the requisite expertise referred to
        in the first subparagraph by having at least two years of professional experience within a
        relevant field of manufacturing.
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                                                DGB 2C                                            EN
 ---pagebreak--- 2.      Micro and small enterprises within the meaning of Commission
        Recommendation 2003/361/EC 1 shall not be required to have the person responsible for
        regulatory compliance within their organisation but shall have such person permanently
        and continuously at their disposal.
3.      The person responsible for regulatory compliance shall at least be responsible for ensuring
        that:
        (a)   the conformity of the devices is appropriately checked, in accordance with the
              quality management system under which the devices are manufactured, before a
              device is released;
        (b)   the technical documentation and the EU declaration of conformity are drawn up and
              kept up-to-date;
        (c)   the post-market surveillance obligations are complied with in accordance with
              Article 10(10);
        (d)   the reporting obligations referred to in Articles 87 to 91 are fulfilled;
        (e)   in the case of investigational devices, the statement referred to in Section 4.1 of
              Chapter II of Annex XV is issued.
1
      Commission Recommendation 2003/361/ΕC of 6 May 2003 concerning the definition of
      micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36).
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                                               DGB 2C                                             EN
 ---pagebreak--- 4.      If a number of persons are jointly responsible for regulatory compliance in accordance
        with paragraphs 1, 2 and 3, their respective areas of responsibility shall be stipulated in
        writing.
5.      The person responsible for regulatory compliance shall suffer no disadvantage within the
        manufacturer's organisation in relation to the proper fulfilment of his or her duties,
        regardless of whether or not they are employees of the organisation.
6.      Authorised representatives shall have permanently and continuously at their disposal at
        least one person responsible for regulatory compliance who possesses the requisite
        expertise regarding the regulatory requirements for medical devices in the Union. The
        requisite expertise shall be demonstrated by either of the following qualifications:
        (a)    a diploma, certificate or other evidence of formal qualification, awarded on
               completion of a university degree or of a course of study recognised as equivalent by
               the Member State concerned, in law, medicine, pharmacy, engineering or another
               relevant scientific discipline, and at least one year of professional experience in
               regulatory affairs or in quality management systems relating to medical devices;
        (b)    four years of professional experience in regulatory affairs or in quality management
               systems relating to medical devices.
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                                                 DGB 2C                                            EN
 ---pagebreak---                                              Article 16
                            Cases in which obligations of manufacturers
                          apply to importers, distributors or other persons
1.      A distributor, importer or other natural or legal person shall assume the obligations
        incumbent on manufacturers if it does any of the following:
        (a)   makes available on the market a device under its name, registered trade name or
              registered trade mark, except in cases where a distributor or importer enters into an
              agreement with a manufacturer whereby the manufacturer is identified as such on the
              label and is responsible for meeting the requirements placed on manufacturers in this
              Regulation;
        (b)   changes the intended purpose of a device already placed on the market or put into
              service;
        (c)   modifies a device already placed on the market or put into service in such a way that
              compliance with the applicable requirements may be affected.
        The first subparagraph shall not apply to any person who, while not considered a
        manufacturer as defined in point (30) of Article 2, assembles or adapts for an individual
        patient a device already on the market without changing its intended purpose.
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                                              DGB 2C                                             EN
 ---pagebreak--- 2.      For the purposes of point (c) of paragraph 1, the following shall not be considered to be a
        modification of a device that could affect its compliance with the applicable requirements:
        (a)   provision, including translation, of the information supplied by the manufacturer, in
              accordance with Section 23 of Annex I, relating to a device already placed on the
              market and of further information which is necessary in order to market the device in
              the relevant Member State;
        (b)   changes to the outer packaging of a device already placed on the market, including a
              change of pack size, if the repackaging is necessary in order to market the device in
              the relevant Member State and if it is carried out in such conditions that the original
              condition of the device cannot be affected by it. In the case of devices placed on the
              market in sterile condition, it shall be presumed that the original condition of the
              device is adversely affected if the packaging that is necessary for maintaining the
              sterile condition is opened, damaged or otherwise negatively affected by the
              repackaging.
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                                                DGB 2C                                            EN
 ---pagebreak--- 3.      A distributor or importer that carries out any of the activities mentioned in points (a)
        and (b) of paragraph 2 shall indicate on the device or, where that is impracticable, on its
        packaging or in a document accompanying the device, the activity carried out together with
        its name, registered trade name or registered trade mark, registered place of business and
        the address at which it can be contacted, so that its location can be established.
        Distributors and importers shall ensure that they have in place a quality management
        system that includes procedures which ensure that the translation of information is accurate
        and up-to-date, and that the activities mentioned in points (a) and (b) of paragraph 2 are
        performed by a means and under conditions that preserve the original condition of the
        device and that the packaging of the repackaged device is not defective, of poor quality or
        untidy. The quality management system shall cover, inter alia, procedures ensuring that
        the distributor or importer is informed of any corrective action taken by the manufacturer
        in relation to the device in question in order to respond to safety issues or to bring it into
        conformity with this Regulation.
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                                                DGB 2C                                              EN
 ---pagebreak--- 4.      At least 28 days prior to making the relabelled or repackaged device available on the
        market, distributors or importers carrying out any of the activities mentioned in points (a)
        and (b) of paragraph 2 shall inform the manufacturer and the competent authority of the
        Member State in which they plan to make the device available of the intention to make the
        relabelled or repackaged device available and, upon request, shall provide the
        manufacturer and the competent authority with a sample or mock-up of the relabelled or
        repackaged device, including any translated label and instructions for use. Within the same
        period of 28 days, the distributor or importer shall submit to the competent authority a
        certificate, issued by a notified body designated for the type of devices that are subject to
        activities mentioned in points (a) and (b) of paragraph 2, attesting that the quality
        management system of the distributer or importer complies with the requirements laid
        down in paragraph 3.
                                              Article 17
                              Single-use devices and their reprocessing
1.      Reprocessing and further use of single-use devices may only take place where permitted by
        national law and only in accordance with this Article.
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                                               DGB 2C                                             EN
 ---pagebreak--- 2.      Any natural or legal person who reprocesses a single-use device to make it suitable for
        further use within the Union shall be considered to be the manufacturer of the reprocessed
        device and shall assume the obligations incumbent on manufacturers laid down in this
        Regulation, which include obligations relating to the traceability of the reprocessed device
        in accordance with Chapter III of this Regulation. The reprocessor of the device shall be
        considered to be a producer for the purpose of Article 3(1) of Directive 85/374/EEC.
3.      By way of derogation from paragraph 2, as regards single-use devices that are reprocessed
        and used within a health institution, Member States may decide not to apply all of the rules
        relating to manufacturers' obligations laid down in this Regulation provided that they
        ensure that:
        (a)    the safety and performance of the reprocessed device is equivalent to that of the
               original device and the requirements in points (a), (b), (d), (e), (f), (g) and (h) of
               Article 5(5) are complied with;
        (b)    the reprocessing is performed in accordance with CS detailing the requirements
               concerning:
               –     risk management, including the analysis of the construction and material,
                     related properties of the device (reverse engineering) and procedures to detect
                     changes in the design of the original device as well as of its planned application
                     after reprocessing,
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                                                DGB 2C                                                EN
 ---pagebreak---               –      the validation of procedures for the entire process, including cleaning steps,
              –      the product release and performance testing,
              –      the quality management system,
              –      the reporting of incidents involving devices that have been reprocessed, and
              –      the traceability of reprocessed devices.
        Member States shall encourage, and may require, health institutions to provide information
        to patients on the use of reprocessed devices within the health institution and, where
        appropriate, any other relevant information on the reprocessed devices that patients are
        treated with.
        Member States shall notify the Commission and the other Member States of the national
        provisions introduced pursuant to this paragraph and the grounds for introducing them. The
        Commission shall keep the information publicly available.
4.      Member States may choose to apply the provisions referred to in paragraph 3 also as
        regards single-use devices that are reprocessed by an external reprocessor at the request of
        a health institution, provided that the reprocessed device in its entirety is returned to that
        health institution and the external reprocessor complies with the requirements referred to in
        points (a) and (b) of paragraph 3.
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                                                DGB 2C                                              EN
 ---pagebreak--- 5.      The Commission shall adopt, in accordance with Article 9(1), the necessary CS referred to
        in point (b) of paragraph 3 by … [date of application of this Regulation]. Those CS shall be
        consistent with the latest scientific evidence and shall address the application of the general
        requirements on safety and performance laid down in in this Regulation. In the event that
        those CS are not adopted by … [date of application of this Regulation], reprocessing shall
        be performed in accordance with any relevant harmonised standards and national
        provisions that cover the aspects outlined in point (b) of paragraph 3. Compliance with CS
        or, in the absence of CS, with any relevant harmonised standards and national provisions,
        shall be certified by a notified body.
6.      Only single-use devices that have been placed on the market in accordance with this
        Regulation, or prior to … [date of application of this Regulation] in accordance with
        Directive 93/42/EEC, may be reprocessed.
7.      Only reprocessing of single-use devices that is considered safe according to the latest
        scientific evidence may be carried out.
8.      The name and address of the legal or natural person referred to in paragraph 2 and the
        other relevant information referred to in Section 23 of Annex I shall be indicated on the
        label and, where applicable, in the instructions for use of the reprocessed device.
        The name and address of the manufacturer of the original single-use device shall no longer
        appear on the label, but shall be mentioned in the instructions for use of the reprocessed
        device.
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 ---pagebreak--- 9.      A Member State that permits reprocessing of single-use devices may maintain or introduce
        national provisions that are stricter than those laid down in this Regulation and which
        restrict or prohibit, within its territory, the following:
        (a)    the reprocessing of single-use devices and the transfer of single-use devices to
               another Member State or to a third country with a view to their reprocessing;
        (b)    the making available or further use of reprocessed single-use devices.
        Member States shall notify the Commission and the other Member States of those national
        provisions. The Commission shall make such information publicly available.
10.     The Commission shall by … [4 years after the date of application of this Regulation] draw
        up a report on the operation of this Article and submit it to the European Parliament and to
        the Council. On the basis of that report, the Commission shall, if appropriate, make
        proposals for amendments to this Regulation.
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 ---pagebreak---                                              Article 18
                     Implant card and information to be supplied to the patient
                                     with an implanted device
1.      The manufacturer of an implantable device shall provide together with the device the
        following:
        (a)   information allowing the identification of the device, including the device name,
              serial number, lot number, the UDI, the device model, as well as the name, address
              and the website of the manufacturer;
        (b)   any warnings, precautions or measures to be taken by the patient or a healthcare
              professional with regard to reciprocal interference with reasonably foreseeable
              external influences, medical examinations or environmental conditions;
        (c)   any information about the expected lifetime of the device and any necessary
              follow-up;
        (d)   any other information to ensure safe use of the device by the patient, including the
              information in point (u) of Section 23.4 of Annex I.
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                                              DGB 2C                                            EN
 ---pagebreak---         The information referred to in the first subparagraph shall be provided, for the purpose of
        making it available to the particular patient who has been implanted with the device, by
        any means that allow rapid access to that information and shall be stated in the language(s)
        determined by the concerned Member State. The information shall be written in a way that
        is readily understood by a lay person and shall be updated where appropriate. Updates of
        the information shall be made available to the patient via the website mentioned in
        point (a) of paragraph 1.
        In addition, the manufacturer shall provide the information referred to in point (a) of the
        first subparagraph on an implant card delivered with the device.
2.      Member States shall require health institutions to make the information referred to in
        paragraph 1 available, by any means that allow rapid access to that information, to any
        patients who have been implanted with the device, together with the implant card, which
        shall bear their identity.
3.      The following implants shall be exempted from the obligations laid down in this Article:
        sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates wires,
        pins, clips and connectors. The Commission is empowered to adopt delegated acts in
        accordance with Article 115 to amend this list by adding other types of implants to it or by
        removing implants therefrom.
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                                                 DGB 2C                                           EN
 ---pagebreak---                                               Article 19
                                    EU declaration of conformity
1.      The EU declaration of conformity shall state that the requirements specified in this
        Regulation have been fulfilled in relation to the device that is covered. The manufacturer
        shall continuously update the EU declaration of conformity. The EU declaration of
        conformity shall, as a minimum, contain the information set out in Annex IV and shall be
        translated into an official Union language or languages required by the Member State(s) in
        which the device is made available.
2.      Where, concerning aspects not covered by this Regulation, devices are subject to other
        Union legislation which also requires an EU declaration of conformity by the manufacturer
        that fulfilment of the requirements of that legislation has been demonstrated, a single
        EU declaration of conformity shall be drawn up in respect of all Union acts applicable to
        the device. The declaration shall contain all the information required for identification of
        the Union legislation to which the declaration relates.
3.      By drawing up the EU declaration of conformity, the manufacturer shall assume
        responsibility for compliance with the requirements of this Regulation and all other Union
        legislation applicable to the device.
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 ---pagebreak--- 4.      The Commission is empowered to adopt delegated acts in accordance with Article 115
        amending the minimum content of the EU declaration of conformity set out in Annex IV in
        the light of technical progress.
                                             Article 20
                                     CE marking of conformity
1.      Devices, other than custom-made or investigational devices, considered to be in
        conformity with the requirements of this Regulation shall bear the CE marking of
        conformity, as presented in Annex V.
2.      The CE marking shall be subject to the general principles set out in Article 30 of
        Regulation (EC) No 765/2008.
3.      The CE marking shall be affixed visibly, legibly and indelibly to the device or its sterile
        packaging. Where such affixing is not possible or not warranted on account of the nature of
        the device, the CE marking shall be affixed to the packaging. The CE marking shall also
        appear in any instructions for use and on any sales packaging.
4.      The CE marking shall be affixed before the device is placed on the market. It may be
        followed by a pictogram or any other mark indicating a special risk or use.
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                                              DGB 2C                                             EN
 ---pagebreak--- 5.      Where applicable, the CE marking shall be followed by the identification number of the
        notified body responsible for the conformity assessment procedures set out in Article 52.
        The identification number shall also be indicated in any promotional material which
        mentions that a device fulfils the requirements for CE marking.
6.      Where devices are subject to other Union legislation which also provides for the affixing of
        the CE marking, the CE marking shall indicate that the devices also fulfil the requirements
        of that other legislation.
                                               Article 21
                                    Devices for special purposes
1.      Member States shall not create obstacles to:
        (a)   investigational devices being supplied to an investigator for the purpose of a clinical
              investigation if they meet the conditions laid down in Articles 62 to 80 and
              Article 82, in the implementing acts adopted pursuant to Article 81 and in
              Annex XV;
        (b)   custom-made devices being made available on the market if Article 52(8) and
              Annex XIII have been complied with.
        The devices referred to in the first subparagraph shall not bear the CE marking, with the
        exception of the devices referred to in Article 74.
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 ---pagebreak--- 2.      Custom-made devices shall be accompanied by the statement referred to in Section 1 of
        Annex XIII, which shall be made available to the particular patient or user identified by
        name, an acronym or a numerical code.
        Member States may require that the manufacturer of a custom-made device submit to the
        competent authority a list of such devices which have been made available in their
        territory.
3.      At trade fairs, exhibitions, demonstrations or similar events, Member States shall not create
        obstacles to the showing of devices which do not comply with this Regulation, provided a
        visible sign clearly indicates that such devices are intended for presentation or
        demonstration purposes only and cannot be made available until they have been brought
        into compliance with this Regulation.
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                                                DGB 2C                                          EN
 ---pagebreak---                                              Article 22
                                    Systems and procedure packs
1.      Natural or legal persons shall draw up a statement if they combine devices bearing a
        CE marking with the following other devices or products, in a manner that is compatible
        with the intended purpose of the devices or other products and within the limits of use
        specified by their manufacturers, in order to place them on the market as a system or
        procedure pack:
        (a)   other devices bearing the CE marking;
        (b)   in vitro diagnostic medical devices bearing the CE marking in conformity with
              Regulation (EU) 2017/… +;
        (c)   other products which are in conformity with legislation that applies to those products
              only where they are used within a medical procedure or their presence in the system
              or procedure pack is otherwise justified.
+
      OJ: Please insert the serial number of the Regulation in st10729/16.
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                                              DGB 2C                                            EN
 ---pagebreak--- 2.      In the statement made pursuant to paragraph 1 the natural or legal person concerned shall
        declare that:
        (a)   they verified the mutual compatibility of the devices and, if applicable other
              products, in accordance with the manufacturers' instructions and have carried out
              their activities in accordance with those instructions;
        (b)   they packaged the system or procedure pack and supplied relevant information to
              users incorporating the information to be supplied by the manufacturers of the
              devices or other products which have been put together;
        (c)   the activity of combining devices and, if applicable, other products as a system or
              procedure pack was subject to appropriate methods of internal monitoring,
              verification and validation.
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                                               DGB 2C                                           EN
 ---pagebreak--- 3.      Any natural or legal person who sterilises systems or procedure packs referred to in
        paragraph 1 for the purpose of placing them on the market shall, at their choice, apply one
        of the procedures set out in Annex IX or the procedure set out in Part A of Annex XI. The
        application of those procedures and the involvement of the notified body shall be limited to
        the aspects of the procedure relating to ensuring sterility until the sterile packaging is
        opened or damaged. The natural or legal person shall draw up a statement declaring that
        sterilisation has been carried out in accordance with the manufacturer's instructions.
4.      Where the system or procedure pack incorporate devices which do not bear the
        CE marking or where the chosen combination of devices is not compatible in view of their
        original intended purpose, or where the sterilisation has not been carried out in accordance
        with the manufacturer's instructions the system or procedure pack shall be treated as a
        device in its own right and shall be subject to the relevant conformity assessment
        procedure pursuant to Article 52. The natural or legal person shall assume the obligations
        incumbent on manufacturers.
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 ---pagebreak--- 5.      The systems or procedure packs referred to in paragraph 1 of this Article shall not
        themselves bear an additional CE marking but they shall bear the name, registered trade
        name or registered trade mark of the person referred to in paragraphs 1 and 3 of this
        Article as well as the address at which that person can be contacted, so that the person's
        location can be established. Systems or procedure packs shall be accompanied by the
        information referred to in Section 23 of Annex I. The statement referred to in paragraph 2
        of this Article shall be kept at the disposal of the competent authorities, after the system or
        procedure pack has been put together, for the period that is applicable under Article 10(8)
        to the devices that have been combined. Where those periods differ, the longest period
        shall apply.
                                                Article 23
                                         Parts and components
1.      Any natural or legal person who makes available on the market an item specifically
        intended to replace an identical or similar integral part or component of a device that is
        defective or worn in order to maintain or restore the function of the device without
        changing its performance or safety characteristics or its intended purpose, shall ensure that
        the item does not adversely affect the safety and performance of the device. Supporting
        evidence shall be kept available for the competent authorities of the Member States.
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                                                 DGB 2C                                            EN
 ---pagebreak--- 2.        An item that is intended specifically to replace a part or component of a device and that
          significantly changes the performance or safety characteristics or the intended purpose of
          the device shall be considered to be a device and shall meet the requirements laid down in
          this Regulation.
                                               Article 24
                                            Free movement
Except where otherwise provided for in this Regulation, Member States shall not refuse, prohibit or
restrict the making available on the market or putting into service within their territory of devices
which comply with the requirements of this Regulation.
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                                                 DGB 2C                                            EN
 ---pagebreak---                                            Chapter III
                   Identification and traceability of devices,
            registration of devices and of economic operators,
                summary of safety and clinical performance,
                     European database on medical devices
                                              Article 25
                               Identification within the supply chain
1.      Distributors and importers shall co-operate with manufacturers or authorised
        representatives to achieve an appropriate level of traceability of devices.
2.      Economic operators shall be able to identify the following to the competent authority, for
        the period referred to in Article 10(8):
        (a)   any economic operator to whom they have directly supplied a device;
        (b)   any economic operator who has directly supplied them with a device;
        (c)   any health institution or healthcare professional to which they have directly supplied
              a device.
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 ---pagebreak---                                                Article 26
                                     Medical devices nomenclature
To facilitate the functioning of the European database on medical devices ('Eudamed') as referred to
in Article 33, the Commission shall ensure that an internationally recognised medical devices
nomenclature is available free of charge to manufacturers and other natural or legal persons
required by this Regulation to use that nomenclature. The Commission shall also endeavour to
ensure that that nomenclature is available to other stakeholders free of charge, where reasonably
practicable.
                                               Article 27
                                  Unique Device Identification system
1.       The Unique Device Identification system ('UDI system') described in Part C of Annex VI
         shall allow the identification and facilitate the traceability of devices, other than
         custom-made and investigational devices, and shall consist of the following:
         (a)    production of a UDI that comprises the following:
                (i)   a UDI device identifier ('UDI-DI') specific to a manufacturer and a device,
                      providing access to the information laid down in Part B of Annex VI;
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                                                DGB 2C                                           EN
 ---pagebreak---               (ii)   a UDI production identifier ('UDI-PI') that identifies the unit of device
                     production and if applicable the packaged devices, as specified in Part C of
                     Annex VI;
        (b)   placing of the UDI on the label of the device or on its packaging;
        (c)   storage of the UDI by economic operators, health institutions and healthcare
              professionals, in accordance with the conditions laid down in paragraphs 8 and 9 of
              this Article respectively;
        (d)   establishment of an electronic system for Unique Device Identification ('UDI
              database') in accordance with Article 28.
2.      The Commission shall, by means of implementing acts, designate one or several entities to
        operate a system for assignment of UDIs pursuant to this Regulation ('issuing entity'). That
        entity or those entities shall satisfy all of the following criteria:
        (a)   the entity is an organisation with legal personality;
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                                                 DGB 2C                                         EN
 ---pagebreak---         (b) its system for the assignment of UDIs is adequate to identify a device throughout its
            distribution and use in accordance with the requirements of this Regulation;
        (c) its system for the assignment of UDIs conforms to the relevant international
            standards;
        (d) the entity gives access to its system for the assignment of UDIs to all interested users
            in accordance with a set of predetermined and transparent terms and conditions;
        (e) the entity undertakes to do the following:
            (i)    operate its system for the assignment of UDIs for at least ten years after its
                   designation;
            (ii)   make available to the Commission and to the Member States, upon request,
                   information concerning its system for the assignment of UDIs;
            (iii) remain in compliance with the criteria for designation and the terms of
                   designation.
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 ---pagebreak---         When designating issuing entities, the Commission shall endeavour to ensure that
        UDI carriers, as defined in Part C of Annex VI, are universally readable regardless of the
        system used by the issuing entity, with a view to minimising financial and administrative
        burdens for economic operators and health institutions.
3.      Before placing a device, other than a custom-made device, on the market, the manufacturer
        shall assign to the device and, if applicable, to all higher levels of packaging, a UDI
        created in compliance with the rules of the issuing entity designated by the Commission in
        accordance with paragraph 2.
        Before a device, other than a custom-made or investigational device, is placed on the
        market the manufacturer shall ensure that the information referred to in Part B of Annex V
        of the device in question are correctly submitted and transferred to the UDI database
        referred to in Article 28.
4.      UDI carriers shall be placed on the label of the device and on all higher levels of
        packaging. Higher levels of packaging shall not be understood to include shipping
        containers.
5.      The UDI shall be used for reporting serious incidents and field safety corrective actions in
        accordance with Article 87.
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                                                DGB 2C                                          EN
 ---pagebreak--- 6.      The Basic UDI-DI, as defined in Part C of Annex VI, of the device shall appear on the
        EU declaration of conformity referred to in Article 19.
7.      As part of the technical documentation referred to in Annex II, the manufacturer shall keep
        up-to-date a list of all UDIs that it has assigned.
8.      Economic operators shall store and keep, preferably by electronic means, the UDI of the
        devices which they have supplied or with which they have been supplied, if those devices
        belong to:
        –     class III implantable devices;
        –     the devices, categories or groups of devices determined by a measure referred to in
              point (a) of paragraph 11.
9.      Health institutions shall store and keep preferably by electronic means the UDI of the
        devices which they have supplied or with which they have been supplied, if those devices
        belong to class III implantable devices.
        For devices other than class III implantable devices, Member States shall encourage, and
        may require, health institutions to store and keep, preferably by electronic means, the UDI
        of the devices with which they have been supplied.
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                                                DGB 2C                                          EN
 ---pagebreak---         Member States shall encourage, and may require, healthcare professionals to store and
        keep preferably by electronic means, the UDI of the devices with which they have been
        supplied with.
10.     The Commission is empowered to adopt delegated acts in accordance with Article 115:
        (a)   amending the list of information set out in Part B of Annex VI in the light of
              technical progress; and
        (b)   amending Annex VI in the light of international developments and technical progress
              in the field of Unique Device Identification.
11.     The Commission may, by means of implementing acts, specify the detailed arrangements
        and the procedural aspects for the UDI system with a view to ensuring its harmonised
        application in relation to any of the following:
        (a)   determining the devices, categories or groups of devices to which the obligation laid
              down in paragraph 8 is to apply;
        (b)   specifying the data to be included in the UDI-PI of specific devices or device
              groups;
        The implementing acts referred to in the first subparagraph shall be adopted in accordance
        with the examination procedure referred to in Article 114(3).
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                                                DGB 2C                                         EN
 ---pagebreak--- 12.     When adopting the measures referred to in paragraph 11, the Commission shall take into
        account all of the following:
        (a)  confidentiality and data protection as referred to in Articles 109 and
             110 respectively;
        (b)  the risk-based approach;
        (c)  the cost-effectiveness of the measures;
        (d)  the convergence of UDI systems developed at international level;
        (e)  the need to avoid duplications in the UDI system;
        (f)  the needs of the healthcare systems of the Member States, and where possible,
             compatibility with other medical device identification systems that are used by
             stakeholders.
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                                             DGB 2C                                          EN
 ---pagebreak---                                               Article 28
                                            UDI database
1.      The Commission, after consulting the MDCG shall set up and manage a UDI database to
        validate, collate, process and make available to the public the information mentioned in
        Part B of Annex VI.
2.      When designing the UDI database, the Commission shall take into account the general
        principles set out in Section 5 of Part C of Annex VI. The UDI database shall be designed
        in particular such that no UDI-PIs and no commercially confidential product information
        can be included therein.
3.      The core data elements to be provided to the UDI database, referred to in Part B of
        Annex VI, shall be accessible to the public free of charge.
4.      The technical design of the UDI database shall ensure maximum accessibility to
        information stored therein, including multi-user access and automatic uploads and
        downloads of that information. The Commission shall provide for technical and
        administrative support to manufacturers and other users of the UDI database.
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 ---pagebreak---                                             Article 29
                                      Registration of devices
1.      Before placing a device, other than a custom-made device, on the market, the
        manufacturer shall, in accordance with the rules of the issuing entity referred to in
        Article 27(2), assign a Basic UDI-DI as defined in Part C of Annex VI to the device
        and shall provide it to the UDI database together with the other core data elements
        referred to in Part B of Annex VI related to that device.
2.      Before placing on the market a system or procedure pack pursuant to Article 22(1) and
        (3), that is not a custom-made device, the natural or legal person responsible shall
        assign to the system or procedure pack, in compliance with the rules of the issuing
        entity, a Basic UDI-DI and shall provide it to the UDI database together with the other
        core data elements referred to in Part B of Annex VI related to that system or procedure
        pack.
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                                              DGB 2C                                          EN
 ---pagebreak--- 3.      For devices that are the subject of a conformity assessment as referred to in the second
        sentence of Article 52(3), or the third subparagraph of Article 52(4), the assignment of
        a Basic UDI-DI referred to in paragraph 1 of this Article shall be done before the
        manufacturer applies to a notified body for that assessment.
        For the devices referred to in the first subparagraph, the notified body shall include a
        reference to the Basic UDI-DI on the certificate issued in accordance with point (a) of
        Section 4 of Chapter I of Annex XII and confirm in Eudamed that the information
        referred to in Section 2.2 of Part A of Annex VI is correct. After the issuing of the
        relevant certificate and before placing the device on the market, the manufacturer shall
        provide the Basic UDI-DI to the UDI database together with the other core data elements
        referred to in Part B of Annex VI related to that device.
4.      Before placing a device on the market, other than a custom-made device, the
        manufacturer shall enter or if, already provided, verify in Eudamed the information
        referred to in Section 2 of Part A of Annex VI, with the exception of Section 2.2
        thereof, and shall thereafter keep the information updated.
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 ---pagebreak---                                               Article 30
                    Electronic system for registration of economic operators
1.      The Commission, after consulting the MDCG, shall set up and manage an electronic
        system to create the single registration number referred to in Article 31(2) and to collate
        and process information that is necessary and proportionate to identify the manufacturer
        and, where applicable, the authorised representative and the importer. The details
        regarding the information to be provided to that electronic system by the economic
        operators are laid down in Section 1 of Part A of Annex VI.
2.      Member States may maintain or introduce national provisions on registration of
        distributors of devices which have been made available on their territory.
3.      Within two weeks of placing a device, other than a custom-made device, on the market,
        importers shall verify that the manufacturer or authorised representative has provided to
        the electronic system the information referred to in paragraph 1.
        Where applicable, importers shall inform the relevant authorised representative or
        manufacturer if the information referred to in paragraph 1 is not included or is incorrect.
        Importers shall add their details to the relevant entry/entries.
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 ---pagebreak---                                               Article 31
                     Registration of manufacturers, authorised representatives
                                            and importers
1.      Before placing a device, other than a custom-made device, on the market,
        manufacturers, authorised representatives and importers shall, in order to register,
        submit to the electronic system referred to in Article 30 the information referred to in
        Section 1 of Part A of Annex VI, provided that they have not already registered in
        accordance with this Article. In cases where the conformity assessment procedure
        requires the involvement of a notified body pursuant to Article 52, the information
        referred to in Section 1 of Part A of Annex VI shall be provided to that electronic
        system before applying to the notified body.
2.      After having verified the data entered pursuant to paragraph 1, the competent authority
        shall obtain a single registration number ('SRN') from the electronic system referred to in
        Article 30 and issue it to the manufacturer, the authorised representative or the importer.
3.      The manufacturer shall use the SRN when applying to a notified body for conformity
        assessment and for accessing Eudamed in order to fulfil its obligations under Article 29.
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 ---pagebreak--- 4.      Within one week of any change occurring in relation to the information referred to in
        paragraph 1 of this Article, the economic operator shall update the data in the electronic
        system referred to in Article 30.
5.      Not later than one year after submission of the information in accordance with paragraph 1,
        and every second year thereafter, the economic operator shall confirm the accuracy of the
        data. In the event of a failure to do so within six months of those deadlines, any
        Member State may take appropriate corrective measures within its territory until that
        economic operator complies with that obligation.
6.      Without prejudice to the economic operator's responsibility for the data, the competent
        authority shall verify the confirmed data referred to in Section 1 of Part A of Annex VI.
7.      The data entered pursuant to paragraph 1 of this Article in the electronic system referred to
        in Article 30 shall be accessible to the public.
8.      The competent authority may use the data to charge the manufacturer, the authorised
        representative or the importer a fee pursuant to Article 111.
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 ---pagebreak---                                                Article 32
                             Summary of safety and clinical performance
1.      For implantable devices and for class III devices, other than custom-made or
        investigational devices, the manufacturer shall draw up a summary of safety and clinical
        performance.
        The summary of safety and clinical performance shall be written in a way that is clear to
        the intended user and, if relevant, to the patient and shall be made available to the public
        via Eudamed.
        The draft of the summary of safety and clinical performance shall be part of the
        documentation to be submitted to the notified body involved in the conformity assessment
        pursuant to Article 52 and shall be validated by that body. After its validation, the notified
        body shall upload the summary to Eudamed. The manufacturer shall mention on the label
        or instructions for use where the summary is available.
2.      The summary of safety and clinical performance shall include at least the following
        aspects:
        (a)   the identification of the device and the manufacturer, including the Basic UDI-DI
              and, if already issued, the SRN;
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 ---pagebreak---         (b)   the intended purpose of the device and any indications, contraindications and target
              populations;
        (c)   a description of the device, including a reference to previous generation(s) or variants
              if such exist, and a description of the differences, as well as, where relevant, a
              description of any accessories, other devices and products, which are intended to be
              used in combination with the device;
        (d)   possible diagnostic or therapeutic alternatives;
        (e)   reference to any harmonised standards and CS applied;
        (f)   the summary of clinical evaluation as referred to in Annex XIV, and relevant
              information on post-market clinical follow-up;
        (g)   suggested profile and training for users;
        (h)   information on any residual risks and any undesirable effects, warnings and
              precautions.
3.      The Commission may, by means of implementing acts, set out the form and the
        presentation of the data elements to be included in the summary of safety and clinical
        performance. Those implementing acts shall be adopted in accordance with the advisory
        procedure referred to in Article 114(2).
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 ---pagebreak---                                              Article 33
                               European database on medical devices
1.      The Commission, after consulting the MDCG, shall set up, maintain and manage the
        European database on medical devices ('Eudamed') for the following purposes:
        (a)  to enable the public to be adequately informed about devices placed on the market,
             the corresponding certificates issued by notified bodies and about the relevant
             economic operators;
        (b)  to enable unique identification of devices within the internal market and to facilitate
             their traceability;
        (c)  to enable the public to be adequately informed about clinical investigations and to
             enable sponsors of clinical investigations to comply with obligations under
             Articles 62 to 80, Article 82, and any acts adopted pursuant to Article 81;
        (d)  to enable manufacturers to comply with the information obligations laid down in
             Articles 87 to 90 or in any acts adopted pursuant to Article 91;
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 ---pagebreak---         (e) to enable the competent authorities of the Member States and the Commission to
            carry out their tasks relating to this Regulation on a well-informed basis and to
            enhance the cooperation between them.
2.      Eudamed shall include the following electronic systems:
        (a) the electronic system for registration of devices referred to in Article 29(4);
        (b) the UDI-database referred to in Article 28;
        (c) the electronic system on registration of economic operators referred to in Article 30;
        (d) the electronic system on notified bodies and on certificates referred to in Article 57;
        (e) the electronic system on clinical investigations referred to in Article 73;
        (f) the electronic system on vigilance and post-market surveillance referred to in
            Article 92;
        (g) the electronic system on market surveillance referred to in Article 100.
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 ---pagebreak--- 3.      When designing Eudamed the Commission shall give due consideration to
        compatibility with national databases and national web-interfaces to allow for import
        and export of data.
4.      The data shall be entered into Eudamed by the Member States, notified bodies, economic
        operators and sponsors as specified in the provisions on the electronic systems referred to
        in paragraph 2. The Commission shall provide for technical and administrative support to
        users of Eudamed.
5.      All the information collated and processed by Eudamed shall be accessible to the
        Member States and to the Commission. The information shall be accessible to notified
        bodies, economic operators, sponsors and the public to the extent specified in the
        provisions on the electronic systems referred to in paragraph 2.
        The Commission shall ensure that public parts of Eudamed are presented in a user-friendly
        and easily-searchable format.
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 ---pagebreak--- 6.      Eudamed shall contain personal data only insofar as necessary for the electronic systems
        referred to in paragraph 2 of this Article to collate and process information in accordance
        with this Regulation. Personal data shall be kept in a form which permits identification of
        data subjects for periods no longer than those referred to in Article 10(8).
7.      The Commission and the Member States shall ensure that data subjects may effectively
        exercise their rights to information, of access, to rectification and to object in accordance
        with Regulation (EC) No 45/2001 and Directive 95/46/EC, respectively. They shall also
        ensure that data subjects may effectively exercise the right of access to data relating to
        them, and the right to have inaccurate or incomplete data corrected and erased. Within their
        respective responsibilities, the Commission and the Member States shall ensure that
        inaccurate and unlawfully processed data are deleted, in accordance with the applicable
        legislation. Corrections and deletions shall be carried out as soon as possible, but no later
        than 60 days after a request is made by a data subject.
8.      The Commission shall, by means of implementing acts, lay down the detailed
        arrangements necessary for the setting up and maintenance of Eudamed. Those
        implementing acts shall be adopted in accordance with the examination procedure referred
        to in Article 114(3). When adopting those implementing acts, the Commission shall ensure
        that, as far as possible, the system is developed in such a way as to avoid having to enter
        the same information twice within the same module or in different modules of the system.
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 ---pagebreak--- 9.      In relation to its responsibilities under this Article and the processing of personal data
        involved therein, the Commission shall be considered to be the controller of Eudamed and
        its electronic systems.
                                               Article 34
                                       Functionality of Eudamed
1.      The Commission shall, in collaboration with the MDCG, draw up the functional
        specifications for Eudamed. The Commission shall draw up a plan for the implementation
        of those specifications by … [12 months after the date of entry into force of this
        Regulation]. That plan shall seek to ensure that Eudamed is fully functional at a date that
        allows the Commission to publish the notice referred to in paragraph 3 of this Article by
        … [two months before the date of application laid down in this Regulation] and that all
        other relevant deadlines laid down in Article 123 of this Regulation and in Article 113 of
        Regulation (EU) 2017/… + are met.
2.      The Commission shall, on the basis of an independent audit report, inform the MDCG
        when it has verified that Eudamed has achieved full functionality and Eudamed meets the
        functional specifications drawn up pursuant to paragraph 1.
+
      OJ: Please insert the serial number of the Regulation in st10729/16.
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 ---pagebreak--- 3.      The Commission shall, after consultation with the MDCG and when it is satisfied that the
        conditions referred to in paragraph 2 have been fulfilled, publish a notice to that effect in
        the Official Journal of the European Union.
                                          Chapter IV
                                        Notified bodies
                                             Article 35
                             Authorities responsible for notified bodies
1.      Any Member State that intends to designate a conformity assessment body as a notified
        body, or has designated a notified body, to carry out conformity assessment activities
        under this Regulation shall appoint an authority ('authority responsible for notified
        bodies'), which may consist of separate constituent entities under national law and shall be
        responsible for setting up and carrying out the necessary procedures for the assessment,
        designation and notification of conformity assessment bodies and for the monitoring of
        notified bodies, including subcontractors and subsidiaries of those bodies.
2.      The authority responsible for notified bodies shall be established, organised and operated
        so as to safeguard the objectivity and impartiality of its activities and to avoid any conflicts
        of interests with conformity assessment bodies.
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 ---pagebreak--- 3.      The authority responsible for notified bodies shall be organised in a manner such that each
        decision relating to designation or notification is taken by personnel different from those
        who carried out the assessment.
4.      The authority responsible for notified bodies shall not perform any activities that notified
        bodies perform on a commercial or competitive basis.
5.      The authority responsible for notified bodies shall safeguard the confidential aspects of the
        information it obtains. However, it shall exchange information on notified bodies with
        other Member States, the Commission and, when required, with other regulatory
        authorities.
6.      The authority responsible for notified bodies shall have a sufficient number of competent
        personnel permanently available for the proper performance of its tasks.
        Where the authority responsible for notified bodies is a different authority from the
        national competent authority for medical devices, it shall ensure that the national authority
        responsible for medical devices is consulted on relevant matters.
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 ---pagebreak--- 7.      Member States shall make publicly available general information on their measures
        governing the assessment, designation and notification of conformity assessment bodies
        and for the monitoring of notified bodies, and on changes which have a significant impact
        on such tasks.
8.      The authority responsible for notified bodies shall participate in the peer-review activities
        provided for in Article 48.
                                               Article 36
                               Requirements relating to notified bodies
1.      Notified bodies shall fulfil the tasks for which they are designated in accordance with this
        Regulation. They shall satisfy the organisational and general requirements and the quality
        management, resource and process requirements that are necessary to fulfil those tasks. In
        particular, notified bodies shall comply with Annex VII.
        In order to meet the requirements referred to in the first subparagraph, notified bodies shall
        have permanent availability of sufficient administrative, technical and scientific personnel
        in accordance with Section 3.1.1 of Annex VII and personnel with relevant clinical
        expertise in accordance with Section 3.2.4 of Annex VII, where possible employed by the
        notified body itself.
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 ---pagebreak---         The personnel referred to in Sections 3.2.3 and 3.2.7 of Annex VII shall be employed by
        the notified body itself and shall not be external experts or subcontractors.
2.      Notified bodies shall make available and submit upon request all relevant documentation,
        including the manufacturer's documentation, to the authority responsible for notified
        bodies to allow it to conduct its assessment, designation, notification, monitoring and
        surveillance activities and to facilitate the assessment outlined in this Chapter.
3.      In order to ensure the uniform application of the requirements set out in Annex VII, the
        Commission may adopt implementing acts, to the extent necessary to resolve issues of
        divergent interpretation and of practical application. Those implementing acts shall be
        adopted in accordance with the examination procedure referred to in Article 114(3).
                                               Article 37
                                   Subsidiaries and subcontracting
1.      Where a notified body subcontracts specific tasks connected with conformity assessment
        or has recourse to a subsidiary for specific tasks connected with conformity assessment, it
        shall verify that the subcontractor or the subsidiary meets the applicable requirements set
        out in Annex VII and shall inform the authority responsible for notified bodies
        accordingly.
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 ---pagebreak--- 2.      Notified bodies shall take full responsibility for the tasks performed on their behalf by
        subcontractors or subsidiaries.
3.      Notified bodies shall make publicly available a list of their subsidiaries.
4.      Conformity assessment activities may be subcontracted or carried out by a subsidiary
        provided that the legal or natural person that applied for conformity assessment has been
        informed accordingly.
5.      Notified bodies shall keep at the disposal of the authority responsible for notified bodies all
        relevant documents concerning the verification of the qualifications of the subcontractor or
        the subsidiary and the work carried out by them under this Regulation.
                                              Article 38
                   Application by conformity assessment bodies for designation
1.      Conformity assessment bodies shall submit an application for designation to the authority
        responsible for notified bodies.
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 ---pagebreak--- 2.      The application shall specify the conformity assessment activities as defined in this
        Regulation, and the types of devices for which the body is applying to be designated, and
        shall be supported by documentation demonstrating compliance with Annex VII.
        In respect of the organisational and general requirements and the quality management
        requirements set out in Sections 1 and 2 of Annex VII, a valid accreditation certificate and
        the corresponding evaluation report delivered by a national accreditation body in
        accordance with Regulation (EC) No 765/2008 may be submitted and shall be taken into
        consideration during the assessment described in Article 39. However, the applicant shall
        make available all the documentation referred to in the first subparagraph to demonstrate
        compliance with those requirements upon request.
3.      The notified body shall update the documentation referred to in paragraph 2 whenever
        relevant changes occur, in order to enable the authority responsible for notified bodies to
        monitor and verify continuous compliance with all the requirements set out in Annex VII.
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 ---pagebreak---                                               Article 39
                                    Assessment of the application
1.      The authority responsible for notified bodies shall within 30 days check that the
        application referred to in Article 38 is complete and shall request the applicant to provide
        any missing information. Once the application is complete that authority shall send it to the
        Commission.
        The authority responsible for notified bodies shall review the application and supporting
        documentation in accordance with its own procedures and shall draw up a preliminary
        assessment report.
2.      The authority responsible for notified bodies shall submit the preliminary assessment
        report to the Commission which shall immediately transmit it to the MDCG.
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 ---pagebreak--- 3.      Within 14 days of the submission referred to in paragraph 2 of this Article, the
        Commission, in conjunction with the MDCG, shall appoint a joint assessment team made
        up of three experts, unless the specific circumstances require a different number of experts,
        chosen from the list referred to in Article 40(2). One of the experts shall be a representative
        of the Commission who shall coordinate the activities of the joint assessment team. The
        other two experts shall come from Member States other than the one in which the applicant
        conformity assessment body is established.
        The joint assessment team shall be comprised of experts who are competent to assess the
        conformity assessment activities and the types of devices which are the subject of the
        application or, in particular when the assessment procedure is initiated in accordance with
        Article 47(3), to ensure that the specific concern can be appropriately assessed.
4.      Within 90 days of its appointment, the joint assessment team shall review the
        documentation submitted with the application in accordance with Article 38. The joint
        assessment team may provide feedback to, or require clarification from, the authority
        responsible for notified bodies on the application and on the planned on-site assessment.
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 ---pagebreak---         The authority responsible for notified bodies together with the joint assessment team shall
        plan and conduct an on-site assessment of the applicant conformity assessment body and,
        where relevant, of any subsidiary or subcontractor, located inside or outside the Union, to
        be involved in the conformity assessment process.
        The on-site assessment of the applicant body shall be led by the authority responsible for
        notified bodies.
5.      Findings regarding non-compliance of an applicant conformity assessment body with the
        requirements set out in Annex VII shall be raised during the assessment process and
        discussed between the authority responsible for notified bodies and the joint assessment
        team with a view to reaching consensus and resolving any diverging opinions, with respect
        to the assessment of the application.
        At the end of the on-site assessment, the authority responsible for notified bodies shall list
        for the applicant conformity assessment body the non-compliances resulting from the
        assessment and summarise the assessment by the joint assessment team.
        Within a specified timeframe, the applicant conformity assessment body shall submit to the
        national authority a corrective and preventive action plan to address the non-compliances.
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 ---pagebreak--- 6.      The joint assessment team shall document any remaining diverging opinions with respect
        to the assessment within 30 days of completion of the on-site assessment and send them to
        the authority responsible for notified bodies.
7.      The authority responsible for notified bodies shall following receipt of a corrective and
        preventive action plan from the applicant body assess whether non-compliances identified
        during the assessment have been appropriately addressed. This plan shall indicate the root
        cause of the identified non-compliances and shall include a timeframe for implementation
        of the actions therein.
        The authority responsible for notified bodies shall having confirmed the corrective and
        preventive action plan forward it and its opinion thereon to the joint assessment team. The
        joint assessment team may request of the authority responsible for notified bodies further
        clarification and modifications.
        The authority responsible for notified bodies shall draw up its final assessment report
        which shall include:
        –      the result of the assessment,
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 ---pagebreak---         –     confirmation that the corrective and preventive actions have been appropriately
              addressed and, where required, implemented,
        –     any remaining diverging opinion with the joint assessment team, and, where
              applicable,
        –     the recommended scope of designation.
8.      The authority responsible for notified bodies shall submit its final assessment report and, if
        applicable, the draft designation to the Commission, the MDCG and the joint assessment
        team.
9.      The joint assessment team shall provide a final opinion regarding the assessment report
        prepared by the authority responsible for notified bodies and, if applicable, the draft
        designation within 21 days of receipt of those documents to the Commission, which shall
        immediately submit that final opinion to the MDCG. Within 42 days of receipt of the
        opinion of the joint assessment team, the MDCG shall issue a recommendation with regard
        to the draft designation which the authority responsible for notified bodies shall duly take
        into consideration for its decision on the designation of the notified body.
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 ---pagebreak--- 10.     The Commission may, by means of implementing acts, adopt measures setting out the
        detailed arrangements specifying procedures and reports for the application for designation
        referred to in Article 38 and the assessment of the application set out in this Article. Those
        implementing acts shall be adopted in accordance with the examination procedure referred
        to in Article 114(3).
                                               Article 40
                              Nomination of experts for joint assessment
                                    of applications for notification
1.      The Member States and the Commission shall nominate experts qualified in the assessment
        of conformity assessment bodies in the field of medical devices to participate in the
        activities referred to in Articles 39 and 48.
2.      The Commission shall maintain a list of the experts nominated pursuant to paragraph 1 of
        this Article, together with information on their specific field of competence and expertise.
        That list shall be made available to Member States competent authorities through the
        electronic system referred to in Article 57.
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 ---pagebreak---                                               Article 41
                                        Language requirements
All documents required pursuant to Articles 38 and 39 shall be drawn up in a language or languages
which shall be determined by the Member State concerned.
Member States, in applying the first paragraph, shall consider accepting and using a commonly
understood language in the medical field, for all or part of the documentation concerned.
The Commission shall provide translations of the documentation pursuant to Articles 38 and 39, or
parts thereof into an official Union language, such as is necessary for that documentation to be
readily understood by the joint assessment team appointed in accordance with Article 39(3).
                                              Article 42
                                Designation and notification procedure
1.       Member States may only designate conformity assessment bodies for which the assessment
         pursuant to Article 39 was completed and which comply with Annex VII.
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 ---pagebreak--- 2.      Member States shall notify the Commission and the other Member States of the conformity
        assessment bodies they have designated, using the electronic notification tool within the
        database of notified bodies developed and managed by the Commission (NANDO).
3.      The notification shall clearly specify, using the codes referred to in paragraph 13 of this
        Article, the scope of the designation indicating the conformity assessment activities as
        defined in this Regulation and the types of devices which the notified body is authorised to
        assess and, without prejudice to Article 44, any conditions associated with the designation.
4.      The notification shall be accompanied by the final assessment report of the authority
        responsible for notified bodies, the final opinion of the joint assessment team referred to in
        Article 39(9) and the recommendation of the MDCG. Where the notifying Member State
        does not follow the recommendation of the MDCG, it shall provide a duly substantiated
        justification.
5.      The notifying Member State shall, without prejudice to Article 44, inform the Commission
        and the other Member States of any conditions associated with the designation and provide
        documentary evidence regarding the arrangements in place to ensure that the notified body
        will be monitored regularly and will continue to satisfy the requirements set out in
        Annex VII.
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 ---pagebreak--- 6.      Within 28 days of the notification referred to in paragraph 2, a Member State or the
        Commission may raise written objections, setting out its arguments, with regard either to
        the notified body or to its monitoring by the authority responsible for notified bodies.
        Where no objection is raised, the Commission shall publish in NANDO the notification
        within 42 days of its having been notified as referred to in paragraph 2.
7.      When a Member State or the Commission raises objections in accordance with
        paragraph 6, the Commission shall bring the matter before the MDCG within 10 days of
        the expiry of the period referred to in paragraph 6. After consulting the parties involved,
        the MDCG shall give its opinion at the latest within 40 days of the matter having been
        brought before it. Where the MDCG is of the opinion that the notification can be accepted,
        the Commission shall publish in NANDO the notification within 14 days.
8.      Where the MDCG, after having been consulted in accordance with paragraph 7, confirms
        the existing objection or raises another objection, the notifying Member State shall provide
        a written response to the MDCG opinion within 40 days of its receipt. The response shall
        address the objections raised in the opinion, and set out the reasons for the notifying
        Member State's decision to designate or not designate the conformity assessment body.
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 ---pagebreak--- 9.      Where the notifying Member State decides to uphold its decision to designate the
        conformity assessment body, having given its reasons in accordance with paragraph 8, the
        Commission shall publish in NANDO the notification within 14 days of being informed
        thereof.
10.     When publishing the notification in NANDO, the Commission shall also add to the
        electronic system referred to in Article 57 the information relating to the notification of the
        notified body along with the documents mentioned in paragraph 4 of this Article and the
        opinion and responses referred to in paragraphs 7 and 8 of this Article.
11.     The designation shall become valid the day after the notification is published in NANDO.
        The published notification shall state the scope of lawful conformity assessment activity of
        the notified body.
12.     The conformity assessment body concerned may perform the activities of a notified body
        only after the designation has become valid in accordance with paragraph 11.
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 ---pagebreak--- 13.     The Commission shall by … [six months after the date of entry into force of this
        Regulation], by means of implementing acts, draw up a list of codes and corresponding
        types of devices for the purpose of specifying the scope of the designation of notified
        bodies. Those implementing acts shall be adopted in accordance with the examination
        procedure referred to in Article 114(3). The Commission, after consulting the MDCG, may
        update this list based, inter alia, on information arising from the coordination activities
        described in Article 48.
                                                Article 43
                           Identification number and list of notified bodies
1.      The Commission shall assign an identification number to each notified body for which the
        notification becomes valid in accordance with Article 42(11). It shall assign a single
        identification number even when the body is notified under several Union acts. If they are
        successfully designated in accordance with this Regulation, bodies notified pursuant to
        Directives 90/385/EEC and 93/42/EEC shall retain the identification number assigned to
        them pursuant to those Directives.
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 ---pagebreak--- 2.      The Commission shall make the list of the bodies notified under this Regulation, including
        the identification numbers that have been assigned to them and the conformity assessment
        activities as defined in this Regulation and the types of devices for which they have been
        notified, accessible to the public in NANDO. It shall also make this list available on the
        electronic system referred to in Article 57. The Commission shall ensure that the list is
        kept up to date.
                                               Article 44
                           Monitoring and re-assessment of notified bodies
1.      Notified bodies shall, without delay, and at the latest within 15 days, inform the authority
        responsible for notified bodies of relevant changes which may affect their compliance with
        the requirements set out in Annex VII or their ability to conduct the conformity assessment
        activities relating to the devices for which they have been designated.
2.      The authorities responsible for notified bodies shall monitor the notified bodies established
        on their territory and their subsidiaries and subcontractors to ensure ongoing compliance
        with the requirements and the fulfilment of its obligations set out in this Regulation.
        Notified bodies shall, upon request by their authority responsible for notified bodies,
        supply all relevant information and documents, required to enable the authority, the
        Commission and other Member States to verify compliance.
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 ---pagebreak--- 3.      Where the Commission or the authority of a Member State submits a request to a notified
        body established on the territory of another Member State relating to a conformity
        assessment carried out by that notified body, it shall send a copy of that request to the
        authority responsible for notified bodies of that other Member State. The notified body
        concerned shall respond without delay and within 15 days at the latest to the request. The
        authority responsible for notified bodies of the Member State in which the body is
        established shall ensure that requests submitted by authorities of any other Member State
        or by the Commission are resolved by the notified body unless there is a legitimate reason
        for not doing so in which case the matter may be referred to the MDCG.
4.      At least once a year, the authorities responsible for notified bodies shall re-assess whether
        the notified bodies established on their respective territory and, where appropriate, the
        subsidiaries and subcontractors under the responsibility of those notified bodies still satisfy
        the requirements and fulfil their obligations set out in Annex VII. That review shall include
        an on-site audit of each notified body and, where necessary, of its subsidiaries and
        subcontractors.
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 ---pagebreak---         The authority responsible for notified bodies shall conduct its monitoring and assessment
        activities according to an annual assessment plan to ensure that it can effectively monitor
        the continued compliance of the notified body with the requirements of this Regulation.
        That plan shall provide a reasoned schedule for the frequency of assessment of the notified
        body and, in particular, associated subsidiaries and subcontractors. The authority shall
        submit its annual plan for monitoring or assessment for each notified body for which it is
        responsible to the MDCG and to the Commission.
5.      The monitoring of notified bodies by the authority responsible for notified bodies shall
        include observed audits of notified body personnel, including where necessary any
        personnel from subsidiaries and subcontractors, as that personnel is in the process of
        conducting quality management system assessments at a manufacturer's facility.
6.      The monitoring of notified bodies conducted by the authority responsible for notified
        bodies shall consider data arising from market surveillance, vigilance and post-market
        surveillance to help guide its activities.
        The authority responsible for notified bodies shall provide for a systematic follow-up of
        complaints and other information, including from other Member States, which may
        indicate non-fulfilment of the obligations by a notified body or its deviation from common
        or best practice.
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 ---pagebreak--- 7.      The authority responsible for notified bodies may in addition to regular monitoring or on-
        site assessments conduct short-notice, unannounced or 'for-cause' reviews if needed to
        address a particular issue or to verify compliance.
8.      The authority responsible for notified bodies shall review the assessments by notified
        bodies of manufacturers' technical documentation, in particular the clinical evaluation
        documentation as further outlined in Article 45.
9.      The authority responsible for notified bodies shall document and record any findings
        regarding non-compliance of the notified body with the requirements set out in Annex VII
        and shall monitor the timely implementation of corrective and preventive actions.
10.     Three years after notification of a notified body, and again every fourth year thereafter, a
        complete re-assessment to determine whether the notified body still satisfies the
        requirements set out in Annex VII shall be conducted by the authority responsible for
        notified bodies of the Member State in which the body is established and by a joint
        assessment team appointed for the purpose of the procedure described in Articles 38
        and 39.
11.     The Commission is empowered to adopt delegated acts in accordance with Article 115 in
        order to amend paragraph 10 to modify the frequency at which the complete re-assessment
        referred to in that paragraph is to be carried out.
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 ---pagebreak--- 12.     The Member States shall report to the Commission and to the MDCG, at least once a year,
        on their monitoring and on-site assessment activities regarding notified bodies and, where
        applicable, subsidiaries and subcontractors. The report shall provide details of the outcome
        of those activities, including activities pursuant to paragraph 7, and shall be treated as
        confidential by the MDCG and the Commission; however it shall contain a summary
        which shall be made publicly available.
        The summary of the report shall be uploaded to the electronic system referred to in
        Article 57.
                                               Article 45
                   Review of notified body assessment of technical documentation
                                and clinical evaluation documentation
1.      The authority responsible for notified bodies, as part of its ongoing monitoring of notified
        bodies, shall review an appropriate number of notified body assessments of manufacturers'
        technical documentation, in particular the clinical evaluation documentation as referred to
        in points (c) and (d) of Section 6.1 of Annex II to verify the conclusions drawn by the
        notified body based on the information presented by the manufacturer. The reviews by the
        authority responsible for notified bodies shall be conducted both off-site and on-site.
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 ---pagebreak--- 2.      The sampling of files to be reviewed in accordance with paragraph 1 shall be planned and
        representative of the types and risk of devices certified by the notified body, in particular
        high risk devices, and be appropriately justified and documented in a sampling plan, which
        shall be made available by the authority responsible for notified bodies to the MDCG upon
        request.
3.      The authority responsible for notified bodies shall review whether the assessment by the
        notified body was conducted appropriately and shall check the procedures used, associated
        documentation and the conclusions drawn by the notified body. Such checking shall
        include the technical documentation and clinical evaluation documentation of the
        manufacturer upon which the notified body has based its assessment. Such reviews shall be
        conducted utilising CS.
4.      Those reviews shall also form part of the re-assessment of notified bodies in accordance
        with Article 44(10) and the joint assessment activities referred to in Article 47(3). The
        reviews shall be conducted utilising appropriate expertise.
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 ---pagebreak--- 5.      Based on the reports of the reviews and assessments by the authority responsible for
        notified bodies or joint assessment teams, on input from the market surveillance, vigilance
        and post-market surveillance activities described in Chapter VII, on the continuous
        monitoring of technical progress, or on the identification of concerns and emerging issues
        on the safety and performance of devices, the MDCG may recommend that the sampling,
        carried out under this Article, cover a greater or lesser proportion of the technical
        documentation and clinical evaluation documentation assessed by a notified body.
6.      The Commission may, by means of implementing acts, adopt measures setting out the
        detailed arrangements, associated documents for, and coordination of, the review of
        assessments of technical documentation and clinical evaluation documentation, as referred
        to in this Article. Those implementing acts shall be adopted in accordance with the
        examination procedure referred to in Article 114(3).
                                              Article 46
                              Changes to designations and notifications
1.      The authority responsible for notified bodies shall notify the Commission and the other
        Member States of any relevant changes to the designation of a notified body.
        The procedures described in Article 39 and in Article 42 shall apply to extensions of the
        scope of the designation.
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 ---pagebreak---         For changes to the designation other than extensions of its scope, the procedures laid down
        in the following paragraphs shall apply.
2.      The Commission shall immediately publish the amended notification in NANDO. The
        Commission shall immediately enter information on the changes to the designation of the
        notified body in the electronic system referred to in Article 57.
3.      Where a notified body decides to cease its conformity assessment activities it shall inform
        the authority responsible for notified bodies and the manufacturers concerned as soon as
        possible and in the case of a planned cessation one year before ceasing its activities. The
        certificates may remain valid for a temporary period of nine months after cessation of the
        notified body's activities on condition that another notified body has confirmed in writing
        that it will assume responsibilities for the devices covered by those certificates. The new
        notified body shall complete a full assessment of the devices affected by the end of that
        time period before issuing new certificates for those devices. Where the notified body has
        ceased its activity, the authority responsible for notified bodies shall withdraw the
        designation.
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 ---pagebreak--- 4.      Where a authority responsible for notified bodies has ascertained that a notified body no
        longer meets the requirements set out in Annex VII, or that it is failing to fulfil its
        obligations or has not implemented the necessary corrective measures, the authority shall
        suspend, restrict, or fully or partially withdraw the designation, depending on the
        seriousness of the failure to meet those requirements or fulfil those obligations.
        A suspension shall not exceed a period of one year, renewable once for the same period.
        The authority responsible for notified bodies shall immediately inform the Commission
        and the other Member States of any suspension, restriction or withdrawal of a designation.
5.      Where its designation has been suspended, restricted, or fully or partially withdrawn, the
        notified body shall inform the manufacturers concerned at the latest within 10 days.
6.      In the event of restriction, suspension or withdrawal of a designation, the authority
        responsible for notified bodies shall take appropriate steps to ensure that the files of the
        notified body concerned are kept and make them available to authorities in other
        Member States responsible for notified bodies and to authorities responsible for market
        surveillance at their request.
7.      In the event of restriction, suspension or withdrawal of a designation, the authority
        responsible for notified bodies shall:
        (a)   assess the impact on the certificates issued by the notified body;
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 ---pagebreak---         (b)  submit a report on its findings to the Commission and the other Member States
             within three months of having notified the changes to the designation;
        (c)  require the notified body to suspend or withdraw, within a reasonable period of time
             determined by the authority, any certificates which were unduly issued to ensure the
             safety of devices on the market;
        (d)  enter into the electronic system referred to in Article 57 information in relation to
             certificates of which it has required their suspension or withdrawal;
        (e)  inform the competent authority for medical devices of the Member State in which the
             manufacturer has its registered place of business through the electronic system
             referred to in Article 57 of the certificates for which it has required suspension or
             withdrawal. That competent authority shall take the appropriate measures, where
             necessary to avoid a potential risk to the health or safety of patients, users or others.
8.      With the exception of certificates unduly issued, and where a designation has been
        suspended or restricted, the certificates shall remain valid in the following circumstances:
        (a)  the authority responsible for notified bodies has confirmed, within one month of the
             suspension or restriction, that there is no safety issue in relation to certificates
             affected by the suspension or restriction, and the authority responsible for notified
             bodies has outlined a timeline and actions anticipated to remedy the suspension or
             restriction; or
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 ---pagebreak---         (b)  the authority responsible for notified bodies has confirmed that no certificates
             relevant to the suspension will be issued, amended or re-issued during the course of
             the suspension or restriction and states whether the notified body has the capability
             of continuing to monitor and remain responsible for existing certificates issued for
             the period of the suspension or restriction. In the event that the authority responsible
             for notified bodies determines that the notified body does not have the capability to
             support existing certificates issued, the manufacturer shall provide, to the competent
             authority for medical devices of the Member State in which the manufacturer of the
             device covered by the certificate has its registered place of business, within three
             months of the suspension or restriction, a written confirmation that another qualified
             notified body is temporarily assuming the functions of the notified body to monitor
             and remain responsible for the certificates during the period of suspension or
             restriction.
9.      With the exception of certificates unduly issued, and where a designation has been
        withdrawn, the certificates shall remain valid for a period of nine months in the following
        circumstances:
        (a)  where the competent authority for medical devices of the Member State in which the
             manufacturer of the device covered by the certificate has its registered place of
             business has confirmed that there is no safety issue associated with the devices in
             question; and
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 ---pagebreak---         (b)    another notified body has confirmed in writing that it will assume immediate
               responsibilities for those devices and will have completed assessment of them within
               twelve months of the withdrawal of the designation.
        In the circumstances referred to in the first subparagraph, the competent authority for
        medical devices of the Member State in which the manufacturer of the device covered by
        the certificate has its place of business may extend the provisional validity of the
        certificates for further periods of three months, which altogether shall not exceed
        twelve months.
        The authority or the notified body assuming the functions of the notified body affected by
        the change of designation shall immediately inform the Commission, the other
        Member States and the other notified bodies thereof.
                                               Article 47
                            Challenge to the competence of notified bodies
1.      The Commission, in conjunction with the MDCG, shall investigate all cases where
        concerns have been brought to its attention regarding the continued fulfilment by a notified
        body, or of one or more of its subsidiaries or subcontractors, of the requirements set out in
        Annex VII or the obligations to which they are subject. It shall ensure that the relevant
        authority responsible for notified bodies is informed and is given an opportunity to
        investigate those concerns.
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 ---pagebreak--- 2.      The notifying Member State shall provide the Commission, on request, with all
        information regarding the designation of the notified body concerned.
3.      The Commission, in conjunction with the MDCG, may initiate, as applicable, the
        assessment procedure described in Article 39(3) and (4) where there is reasonable concern
        about the ongoing compliance of a notified body or a subsidiary or subcontractor of the
        notified body with the requirements set out in Annex VII and where the investigation by
        the authority responsible for notified bodies is not deemed to have fully addressed the
        concerns or upon request of the authority responsible for notified bodies. The reporting and
        outcome of that assessment shall follow the principles of Article 39. Alternatively,
        depending on the severity of the issue, the Commission, in conjunction with the MDCG,
        may request that the authority responsible for notified bodies allow the participation of up
        to two experts from the list established pursuant to Article 40 in an on-site assessment as
        part of the planned monitoring and assessment activities in accordance with Article 44 and
        as outlined in the annual assessment plan described in Article 44(4).
4.      Where the Commission ascertains that a notified body no longer meets the requirements
        for its designation, it shall inform the notifying Member State accordingly and request it to
        take the necessary corrective measures, including the suspension, restriction or withdrawal
        of the designation if necessary.
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 ---pagebreak---         Where the Member State fails to take the necessary corrective measures, the Commission
        may, by means of implementing acts, suspend, restrict or withdraw the designation. Those
        implementing acts shall be adopted in accordance with the examination procedure referred
        to in Article 114(3). It shall notify the Member State concerned of its decision and update
        NANDO and the electronic system referred to in Article 57.
5.      The Commission shall ensure that all confidential information obtained in the course of its
        investigations is treated accordingly.
                                                Article 48
                               Peer review and exchange of experience
                         between authorities responsible for notified bodies
1.      The Commission shall provide for the organisation of exchange of experience and
        coordination of administrative practice between the authorities responsible for notified
        bodies. Such exchange shall cover elements including:
        (a)   development of best practice documents relating to the activities of the authorities
              responsible for notified bodies;
        (b)   development of guidance documents for notified bodies in relation to the
              implementation of this Regulation;
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 ---pagebreak---         (c)   training and qualification of the experts referred to in Article 40;
        (d)   monitoring of trends relating to changes to notified body designations and
              notifications and trends in certificate withdrawals and transfers between notified
              bodies;
        (e)   monitoring of the application and applicability of scope codes referred to in
              Article 42(13);
        (f)   development of a mechanism for peer reviews between authorities and the
              Commission;
        (g)   methods of communication to the public on the monitoring and surveillance activities
              of authorities and the Commission on notified bodies.
2.      The authorities responsible for notified bodies shall participate in a peer review every third
        year through the mechanism developed pursuant to paragraph 1 of this Article. Such
        reviews shall normally be conducted in parallel with the on-site joint assessments
        described in Article 39. Alternatively, an authority may make the choice of having such
        reviews take place as part of its monitoring activities referred to in Article 44.
3.      The Commission shall participate in the organisation and provide support to the
        implementation of the peer review mechanism.
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 ---pagebreak--- 4.       The Commission shall compile an annual summary report of the peer review activities
         which shall be made publicly available.
5.       The Commission may, by means of implementing acts, adopt measures setting out the
         detailed arrangements and related documents for the peer review mechanism and training
         and qualification as referred to in paragraph 1 of this Article. Those implementing acts
         shall be adopted in accordance with the examination procedure referred to in
         Article 114(3).
                                               Article 49
                                     Coordination of notified bodies
The Commission shall ensure that appropriate coordination and cooperation between notified
bodies is put in place and operated in the form of a coordination group of notified bodies in the field
of medical devices, including in vitro diagnostic medical devices. This group shall meet on a
regular basis and at least annually.
The bodies notified under this Regulation shall participate in the work of that group.
The Commission may establish the specific arrangements for the functioning of the coordination
group of notified bodies.
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 ---pagebreak---                                                  Article 50
                                           List of standard fees
Notified bodies shall establish lists of their standard fees for the conformity assessment activities
that they carry out and shall make those lists publicly available.
                                              Chapter V
                      Classification and conformity assessment
                                               SECTION 1
                                           CLASSIFICATION
                                                 Article 51
                                         Classification of devices
1.       Devices shall be divided into classes I, IIa, IIb and III, taking into account the intended
         purpose of the devices and their inherent risks. Classification shall be carried out in
         accordance with Annex VIII.
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 ---pagebreak--- 2.      Any dispute between the manufacturer and the notified body concerned, arising from the
        application of Annex VIII, shall be referred for a decision to the competent authority of the
        Member State in which the manufacturer has its registered place of business. In cases
        where the manufacturer has no registered place of business in the Union and has not yet
        designated an authorised representative, the matter shall be referred to the competent
        authority of the Member State in which the authorised representative referred to in the last
        indent of point (b) of the second paragraph of Section 2.2 of Annex IX has its registered
        place of business. Where the notified body concerned is established in a Member State
        other than that of the manufacturer, the competent authority shall adopt its decision after
        consultation with the competent authority of the Member State that designated the notified
        body.
        The competent authority of the Member State in which the manufacturer has its registered
        place of business shall notify the MDCG and the Commission of its decision. The decision
        shall be made available upon request.
3.      At the request of a Member State the Commission shall after consulting the MDCG,
        decide, by means of implementing acts, on the following:
        (a)   application of Annex VIII to a given device, or category or group of devices, with a
              view to determining the classification of such devices;
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 ---pagebreak---         (b)   that a device, or category or group of devices, shall for reasons of public health based
              on new scientific evidence, or based on any information which becomes available in
              the course of the vigilance and market surveillance activities be reclassified, by way
              of derogation from Annex VIII.
4.      The Commission may also, on its own initiative and after consulting the MDCG, decide,
        by means of implementing acts, on the issues referred to in points (a) and (b) of
        paragraph 3.
5.      In order to ensure the uniform application of Annex VIII, and taking account of the
        relevant scientific opinions of the relevant scientific committees, the Commission may
        adopt implementing acts to the extent necessary to resolve issues of divergent
        interpretation and of practical application.
6.      The implementing acts referred to in paragraphs 3, 4 and 5 of this Article shall be adopted
        in accordance with the examination procedure referred to in Article 114(3).
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 ---pagebreak---                                              SECTION 2
                                   CONFORMITY ASSESSMENT
                                              Article 52
                                 Conformity assessment procedures
1.      Prior to placing a device on the market, manufacturers shall undertake an assessment of the
        conformity of that device, in accordance with the applicable conformity assessment
        procedures set out in Annexes IX to XI.
2.      Prior to putting into service a device that is not placed on the market, manufacturers shall
        undertake an assessment of the conformity of that device, in accordance with the
        applicable conformity assessment procedures set out in Annexes IX to XI.
3.      Manufacturers of class III devices, other than custom-made or investigational devices,
        shall be subject to a conformity assessment as specified in Annex IX. Alternatively, the
        manufacturer may choose to apply a conformity assessment as specified in Annex X
        coupled with a conformity assessment as specified in Annex XI.
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 ---pagebreak--- 4.      Manufacturers of class IIb devices, other than custom-made or investigational devices,
        shall be subject to a conformity assessment as specified in Chapters I and III of Annex IX,
        and including an assessment of the technical documentation as specified in Section 4 of
        that Annex of at least one representative device per generic device group.
        However, for class IIb implantable devices, except sutures, staples, dental fillings, dental
        braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors, the
        assessment of the technical documentation as specified in Section 4Annex IX shall apply
        for every device.
        Alternatively, the manufacturer may choose to apply a conformity assessment based on
        type examination as specified in Annex X coupled with a conformity assessment based on
        product conformity verification as specified in Annex XI.
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 ---pagebreak--- 5.      Where justified in view of well-established technologies, similar to those used in the
        exempted devices listed in the second subparagraph of paragraph 4 of this Article, being
        used in other class IIb implantable devices, or where justified in order to protect the health
        and safety of patients, users or other persons or other aspects of public health, the
        Commission is empowered to adopt delegated acts in accordance with Article 115 to
        amend that list by adding other types of class IIb implantable devices to that list or
        removing devices therefrom.
6.      Manufacturers of class IIa devices, other than custom-made or investigational devices,
        shall be subject to a conformity assessment as specified in Chapters I and III of Annex IX,
        and including an assessment of the technical documentation as specified in Section 4 of
        that Annex of at least one representative device for each category of devices.
        Alternatively, the manufacturer may choose to draw up the technical documentation set out
        in Annexes II and III coupled with a conformity assessment as specified in Section 10 or
        Section 18 of Annex XI. The assessment of the technical documentation shall apply for at
        least one representative device for each category of devices.
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 ---pagebreak--- 7.      Manufacturers of class I devices, other than custom-made or investigational devices, shall
        declare the conformity of their products by issuing the EU declaration of conformity
        referred to in Article 19 after drawing up the technical documentation set out in Annexes II
        and III. If those devices are placed on the market in sterile condition, have a measuring
        function or are reusable surgical instruments, the manufacturer shall apply the procedures
        set out in Chapters I and III of Annex IX, or in Part A of Annex XI. However, the
        involvement of the notified body in those procedures shall be limited:
        (a)   in the case of devices placed on the market in sterile condition, to the aspects relating
              to establishing, securing and maintaining sterile conditions;
        (b)   in the case of devices with a measuring function, to the aspects relating to the
              conformity of the devices with the metrological requirements;
        (c)   in the case of reusable surgical instruments, to the aspects relating to the reuse of the
              device, in particular cleaning, disinfection, sterilization, maintenance and functional
              testing and the related instructions for use.
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 ---pagebreak--- 8.      Manufacturers of custom-made devices shall follow the procedure set out in Annex XIII
        and draw up the statement set out in Section 1 of that Annex before placing such devices
        on the market.
        In addition to the procedure applicable pursuant to the first subparagraph, manufacturers of
        class III custom-made implantable devices shall be subject to the conformity assessment as
        specified in Chapter I of Annex IX. Alternatively, the manufacturer may choose to apply a
        conformity assessment as specified in Part A of Annex XI.
9.      In addition to the procedures applicable pursuant to paragraph 3, 4, 6, or 7 of this Article,
        in the case of devices referred to in the first subparagraph of Article 1(8), the procedure
        specified in Section 5.2 of Annex IX or Section 6 of Annex X, as applicable, shall also
        apply.
10.     In addition to the procedures applicable pursuant to paragraph 3, 4, 6, or 7 of this Article,
        in the case of devices that are covered by this Regulation in accordance with point (f) or
        (g) of Article 1(6) and with the first subparagraph of Article 1(10), the procedure specified
        in Section 5.3 of Annex IX or Section 6 of Annex X, as applicable, shall also apply.
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 ---pagebreak--- 11.     In addition to the procedures applicable pursuant to paragraph 3, 4, 6, or 7, in the case of
        devices that are composed of substances or of combinations of substances that are intended
        to be introduced into the human body via a body orifice or applied to the skin and that are
        absorbed by or locally dispersed in the human body, the procedure specified in Section 5.4
        of Annex IX or Section 6 of Annex X, as applicable, shall also apply.
12.     The Member State in which the notified body is established may require that all or certain
        documents, including the technical documentation, audit, assessment and inspection
        reports, relating to the procedures referred to in paragraphs 1 to 7 and 9 to 11 be made
        available in an official Union language(s) determined by that Member State. In the absence
        of such requirement, those documents shall be available in any official Union language
        acceptable to the notified body.
13.     Investigational devices shall be subject to the requirements set out in Articles 62 to 81.
14.     The Commission may, by means of implementing acts, specify detailed arrangements and
        procedural aspects with a view to ensuring the harmonised application of the conformity
        assessment procedures by the notified bodies for any of the following aspects:
        (a)   the frequency and the sampling basis of the assessment of the technical
              documentation on a representative basis as set out in the third paragraph of
              Section 2.3 and in Section 3.5 of Annex IX in the case of class IIa and class IIb
               devices, and in Section 10.2 of Annex XI in the case of class IIa devices;
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 ---pagebreak---         (b)   the minimum frequency of unannounced on-site audits and sample tests to be
              conducted by notified bodies in accordance with Section 3.4 of Annex IX, taking into
              account the risk-class and the type of device;
        (c)   the physical, laboratory or other tests to be carried out by notified bodies in the
              context of sample tests, assessment of the technical documentation and type
              examination in accordance with Sections 3.4 and 4.3 of Annex IX, Section 3 of
              Annex X and Section 15 of Annex XI.
        The implementing acts referred to in the first subparagraph shall be adopted in accordance
        with the examination procedure referred to in Article 114(3).
                                              Article 53
                                    Involvement of notified bodies
                                in conformity assessment procedures
1.      Where the conformity assessment procedure requires the involvement of a notified body,
        the manufacturer may apply to a notified body of its choice, provided that the chosen
        notified body is designated for conformity assessment activities related to the types of
        devices concerned. The manufacturer may not lodge an application in parallel with another
        notified body for the same conformity assessment procedure.
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 ---pagebreak--- 2.      The notified body concerned shall, by means of the electronic system referred to in
        Article 57, inform the other notified bodies of any manufacturer that withdraws its
        application prior to the notified body's decision regarding the conformity assessment.
3.      When applying to a notified body under paragraph 1, manufacturers shall declare whether
        they have withdrawn an application with another notified body prior to the decision of that
        notified body and provide information about any previous application for the same
        conformity assessment that has been refused by another notified body.
4.      The notified body may require any information or data from the manufacturer which is
        necessary in order to properly conduct the chosen conformity assessment procedure.
5.      Notified bodies and the personnel of notified bodies shall carry out their conformity
        assessment activities with the highest degree of professional integrity and the requisite
        technical and scientific competence in the specific field and shall be free from all pressures
        and inducements, particularly financial, which might influence their judgement or the
        results of their conformity assessment activities, especially as regards persons or groups
        with an interest in the results of those activities.
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 ---pagebreak---                                               Article 54
                             Clinical evaluation consultation procedure
                              for certain class III and class IIb devices
1.      In addition to the procedures applicable pursuant to Article 52, a notified body shall also
        follow the procedure regarding clinical evaluation consultation as specified in Section 5.1
        of Annex IX or as referred to in Section 6 of Annex X, as applicable, when performing a
        conformity assessment of the following devices:
        (a)   class III implantable devices, and
        (b)   class IIb active devices intended to administer and/or remove a medicinal product, as
              referred to in Section 6.4 of Annex VIII (Rule 12).
2.      The procedure referred to in paragraph 1 shall not be required for the devices referred to
        therein:
        (a)   in the case of renewal of a certificate issued under this Regulation;
        (b)   where the device has been designed by modifying a device already marketed by the
              same manufacturer for the same intended purpose, provided that the manufacturer
              has demonstrated to the satisfaction of the notified body that the modifications do not
              adversely affect the benefit-risk ratio of the device; or
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 ---pagebreak---         (c)   where the principles of the clinical evaluation of the device type or category have
              been addressed in a CS referred to in Article 9 and the notified body confirms that
              the clinical evaluation of the manufacturer for this device is in compliance with the
              relevant CS for clinical evaluation of that kind of device.
3.      The notified body shall notify the competent authorities, the authority responsible for
        notified bodies and the Commission through the electronic system referred to in Article 57
        of whether or not the procedure referred to in paragraph 1 of this Article is to be applied.
        That notification shall be accompanied by the clinical evaluation assessment report.
4.      The Commission shall draw up an annual overview of devices which have been subject to
        the procedure specified in Section 5.1 of Annex IX and referred to in Section 6 of
        Annex X. The annual overview shall include the notifications in accordance with
        paragraph 3 of this Article and point (e) of Section 5.1 of Annex IX and a listing of the
        cases where the notified body did not follow the advice from the expert panel. The
        Commission shall submit this overview to the European Parliament, to the Council and to
        the MDCG.
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 ---pagebreak--- 5.      The Commission shall by … [5 years after the date of application of this Regulation] draw
        up a report on the operation of this Article and submit it to the European Parliament and to
        the Council. The report shall take into account the annual overviews and any available
        relevant recommendations from the MDCG. On the basis of that report the Commission
        shall, if appropriate, make proposals for amendments to this Regulation.
                                               Article 55
                         Mechanism for scrutiny of conformity assessments
                               of certain class III and class IIb devices
1.      A notified body shall notify the competent authorities of certificates it has granted to
        devices for which the conformity assessment has been performed pursuant to Article 54(1).
        Such notification shall take place through the electronic system referred to in Article 57
        and shall include the summary of safety and clinical performance pursuant to Article 32,
        the assessment report by the notified body, the instructions for use referred to in
        Section 23.4 of Annex I, and, where applicable, the scientific opinion of the expert panels
        referred to in Section 5.1 of Annex IX or Section 6 of Annex X, as applicable. In the case
        of divergent views between the notified body and the expert panels, a full justification shall
        also be included.
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 ---pagebreak--- 2.      A competent authority and, where applicable, the Commission may, based on reasonable
        concerns apply further procedures in accordance with Article 44, 45, 46, 47 or 94 and,
        where deemed necessary, take appropriate measures in accordance with Articles 95 and 97.
3.      The MDCG and, where applicable, the Commission, may, based on reasonable concerns,
        request scientific advice from the expert panels in relation to the safety and performance of
        any device.
                                               Article 56
                                      Certificates of conformity
1.      The certificates issued by the notified bodies in accordance with Annexes IX, X and XI
        shall be in an official Union language determined by the Member State in which the
        notified body is established or otherwise in an official Union language acceptable to the
        notified body. The minimum content of the certificates shall be as set out in Annex XII.
2.      The certificates shall be valid for the period they indicate, which shall not exceed five
        years. On application by the manufacturer, the validity of the certificate may be extended
        for further periods, each not exceeding five years, based on a re-assessment in accordance
        with the applicable conformity assessment procedures. Any supplement to a certificate
        shall remain valid as long as the certificate which it supplements is valid.
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 ---pagebreak--- 3.      Notified bodies may impose restrictions to the intended purpose of a device to certain
        groups of patients or require manufacturers to undertake specific PMCF studies pursuant to
        Part B of Annex XIV.
4.      Where a notified body finds that the requirements of this Regulation are no longer met by
        the manufacturer, it shall, taking account of the principle of proportionality, suspend or
        withdraw the certificate issued or impose any restrictions on it unless compliance with
        such requirements is ensured by appropriate corrective action taken by the manufacturer
        within an appropriate deadline set by the notified body. The notified body shall give the
        reasons for its decision.
5.      The notified body shall enter in the electronic system referred to in Article 57 any
        information regarding certificates issued, including amendments and supplements thereto,
        and regarding suspended, reinstated, withdrawn or refused certificates and restrictions
        imposed on certificates. Such information shall be accessible to the public.
6.      In the light of technical progress, the Commission is empowered to adopt delegated acts in
        accordance with Article 115 amending the minimum content of the certificates set out in
        Annex XII.
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 ---pagebreak---                                                Article 57
                                 Electronic system on notified bodies
                                  and on certificates of conformity
1.      The Commission, after consulting the MDCG, shall set up and manage an electronic
        system to collate and process the following information:
        (a)  the list of subsidiaries referred to in Article 37(3);
        (b)  the list of experts referred to in Article 40(2);
        (c)  the information relating to the notification referred to in Article 42(10) and the
             amended notifications referred to in Article 46(2);
        (d)  the list of notified bodies referred to in Article 43(2);
        (e)  the summary of the report referred to in Article 44(12);
        (f)  the notifications for conformity assessments and certificates referred to in
             Articles 54(3) and 55(1);
        (g)  withdrawal or refusals of applications for the certificates as referred to in
             Article 53(2) and Section 4.3 of Annex VII;
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 ---pagebreak---         (h)   the information regarding certificates referred to in Article 56(5);
        (i)   the summary of safety and clinical performance referred to in Article 32.
2.      The information collated and processed by the electronic system shall be accessible to the
        competent authorities of the Member States, to the Commission, where appropriate to the
        notified bodies and where provided elsewhere in this regulation or in
        Regulation (EU) 2017/… + to the public.
                                             Article 58
                                 Voluntary change of notified body
1.      In cases where a manufacturer terminates its contract with a notified body and enters into a
        contract with another notified body in respect of the conformity assessment of the same
        device, the detailed arrangements for the change of notified body shall be clearly defined
        in an agreement between the manufacturer, the incoming notified body and, where
        practicable the outgoing notified body. That agreement shall cover at least the following
        aspects:
        (a)   the date on which the certificates issued by the outgoing notified body become
              invalid;
+
      OJ: Please insert the serial number of the Regulation in st10729/16.
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 ---pagebreak---         (b)    the date until which the identification number of the outgoing notified body may be
               indicated in the information supplied by the manufacturer, including any promotional
               material;
        (c)    the transfer of documents, including confidentiality aspects and property rights;
        (d)    the date after which the conformity assessment tasks of the outgoing notified body is
               assigned to the incoming notified body;
        (e)    the last serial number or lot number for which the outgoing notified body is
               responsible.
2.      The outgoing notified body shall withdraw the certificates it has issued for the device
        concerned on the date on which they become invalid.
                                               Article 59
                        Derogation from the conformity assessment procedures
1.      By way of derogation from Article 52, any competent authority may authorise, on a duly
        justified request, the placing on the market or putting into service within the territory of the
        Member State concerned, of a specific device for which the procedures referred to in that
        Article have not been carried out but use of which is in the interest of public health or
        patient safety or health.
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 ---pagebreak--- 2.      The Member State shall inform the Commission and the other Member States of any
        decision to authorise the placing on the market or putting into service of a device in
        accordance with paragraph 1 where such authorisation is granted for use other than for a
        single patient.
3.      Following a notification pursuant to paragraph 2 of this Article, the Commission, in
        exceptional cases relating to public health or patient safety or health, may, by means of
        implementing acts, extend for a limited period of time the validity of an authorisation
        granted by a Member State in accordance with paragraph 1 of this Article to the territory of
        the Union and set the conditions under which the device may be placed on the market or
        put into service. Those implementing acts shall be adopted in accordance with the
        examination procedure referred to in Article 114(3).
        On duly justified imperative grounds of urgency relating to the health and safety of
        humans, the Commission shall adopt immediately applicable implementing acts in
        accordance with the procedure referred to in Article 114(4).
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 ---pagebreak---                                                  Article 60
                                         Certificate of free sale
1.      For the purpose of export and upon request by a manufacturer or an authorised
        representative, the Member State in which the manufacturer or the authorised
        representative has its registered place of business shall issue a certificate of free sale
        declaring that the manufacturer or the authorised representative, as applicable, has its
        registered place of business on its territory and that the device in question bearing the
        CE marking in accordance with this Regulation may be marketed in the Union. The
        certificate of free sale shall set out the Basic UDI-DI of the device as provided to the
        UDI database under Article 29. Where a notified body has issued a certificate pursuant to
        Article 56, the certificate of free sale shall set out the unique number identifying the
        certificate issued by the notified body, as referred to in Section 3 of Chapter II of
        Annex XII.
2.      The Commission may, by means of implementing acts, establish a model for certificates of
        free sale, taking into account international practice as regards the use of certificates of free
        sale. Those implementing acts shall be adopted in accordance with the advisory procedure
        referred to in Article 114(2).
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 ---pagebreak---                                            Chapter VI
                  Clinical evaluation and clinical investigations
                                              Article 61
                                          Clinical evaluation
1.      Confirmation of conformity with relevant general safety and performance requirements set
        out in Annex I under the normal conditions of the intended use of the device, and the
        evaluation of the undesirable side-effects and of the acceptability of the benefit-risk- ratio
        referred to in Sections 1 and 8 of Annex I, shall be based on clinical data providing
        sufficient clinical evidence, including where applicable relevant data as referred to in
        Annex III.
        The manufacturer shall specify and justify the level of clinical evidence necessary to
        demonstrate conformity with the relevant general safety and performance requirements.
        That level of clinical evidence shall be appropriate in view of the characteristics of the
        device and its intended purpose.
        To that end, manufacturers shall plan, conduct and document a clinical evaluation in
        accordance with this Article and Part A of Annex XIV.
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 ---pagebreak--- 2.      For all class III devices and for the class IIb devices referred to in point (b) of
        Article 54(1), the manufacturer may, prior to its clinical evaluation and/or investigation,
        consult an expert panel as referred to in Article 106, with the aim of reviewing the
        manufacturer's intended clinical development strategy and proposals for clinical
        investigation. The manufacturer shall give due consideration to the views expressed by the
        expert panel. Such consideration shall be documented in the clinical evaluation report
        referred to in paragraph 12 of this Article.
        The manufacturer may not invoke any rights to the views expressed by the expert panel
        with regard to any future conformity assessment procedure.
3.      A clinical evaluation shall follow a defined and methodologically sound procedure based
        on the following:
        (a)   a critical evaluation of the relevant scientific literature currently available relating to
              the safety, performance, design characteristics and intended purpose of the device,
              where the following conditions are satisfied:
              –      it is demonstrated that the device subject to clinical evaluation for the intended
                     purpose is equivalent to the device to which the data relate, in accordance with
                     Section 3 of Annex XIV, and
              –      the data adequately demonstrate compliance with the relevant general safety
                     and performance requirements;
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 ---pagebreak---         (b)    a critical evaluation of the results of all available clinical investigations, taking duly
               into consideration whether the investigations were performed under Articles 62
               to 80, any acts adopted pursuant to Article 81, and Annex XV; and
        (c)    a consideration of currently available alternative treatment options for that purpose,
               if any.
4.      In the case of implantable devices and class III devices, clinical investigations shall be
        performed, except if:
        –      the device has been designed by modifications of a device already marketed by the
               same manufacturer,
        –      the modified device has been demonstrated by the manufacturer to be equivalent to
               the marketed device, in accordance with Section 3 of Annex XIV and this
               demonstration has been endorsed by the notified body, and
        –      the clinical evaluation of the marketed device is sufficient to demonstrate conformity
               of the modified device with the relevant safety and performance requirements.
        In this case the notified body shall check that the PMCF plan is appropriate and includes
        post market studies to demonstrate the safety and performance of the device.
        In addition, clinical investigations need not be performed in the cases referred to in
        paragraph 6.
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 ---pagebreak--- 5.      A manufacturer of a device demonstrated to be equivalent to an already marketed device
        not manufactured by him, may also rely on paragraph 4 in order not to perform a clinical
        investigation provided that the following conditions are fulfilled in addition to what is
        required in that paragraph:
        –     the two manufacturers have a contract in place that explicitly allows the
              manufacturer of the second device full access to the technical documentation on an
              ongoing basis, and
        –     the original clinical evaluation has been performed in compliance with the
              requirements of this Regulation,
        and the manufacturer of the second device provides clear evidence thereof to the notified
        body.
6.      The requirement to perform clinical investigations pursuant to paragraph 4 shall not apply
        to implantable devices and class III devices:
        (a)   which have been lawfully placed on the market or put into service in accordance with
              Directive 90/385/EEC or Directive 93/42/EEC and for which the clinical evaluation:
              –     is based on sufficient clinical data, and
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 ---pagebreak---               –      is in compliance with the relevant product-specific CS for the clinical
                     evaluation of that kind of device, where such a CS is available; or
        (b)   that are sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges,
              plates, wires, pins, clips or connectors for which the clinical evaluation is based on
              sufficient clinical data and is in compliance with the relevant product-specific CS,
              where such a CS is available.
7.      Cases in which paragraph 4 is not applied by virtue of paragraph 6 shall be justified in the
        clinical evaluation report by the manufacturer and in the clinical evaluation assessment
        report by the notified body.
8.      Where justified in view of well-established technologies, similar to those used in the
        exempted devices listed in point (b) of paragraph 6 of this Article, being used in other
        devices, or where justified in order to protect the health and safety of patients, users or
        other persons or other aspects of public health, the Commission is empowered to adopt
        delegated acts in accordance with Article 115 to amend the list of exempted devices
        referred to in the second subparagraph of Article 52(4) and in point (b) of paragraph 6 of
        this Article, by adding other types of implantable or class III devices to that list or
        removing devices therefrom.
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 ---pagebreak--- 9.      In the case of the products without an intended medical purpose listed in Annex XVI, the
        requirement to demonstrate a clinical benefit in accordance with this Chapter and
        Annexes XIV and XV shall be understood as a requirement to demonstrate the
        performance of the device. Clinical evaluations of those products shall be based on
        relevant data concerning safety, including data from post-market surveillance, PMCF, and,
        where applicable, specific clinical investigation. Clinical investigations shall be performed
        for those products unless reliance on existing clinical data from an analogous medical
        device is duly justified.
10.     Without prejudice to paragraph 4, where the demonstration of conformity with general
        safety and performance requirements based on clinical data is not deemed appropriate,
        adequate justification for any such exception shall be given based on the results of the
        manufacturer's risk management and on consideration of the specifics of the interaction
        between the device and the human body, the clinical performance intended and the claims
        of the manufacturer. In such a case, the manufacturer shall duly substantiate in the
        technical documentation referred to in Annex II why it considers a demonstration of
        conformity with general safety and performance requirements that is based on the results
        of non-clinical testing methods alone, including performance evaluation, bench testing and
        pre-clinical evaluation, to be adequate.
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 ---pagebreak--- 11.     The clinical evaluation and its documentation shall be updated throughout the life cycle of
        the device concerned with clinical data obtained from the implementation of the
        manufacturer's PMCF plan in accordance with Part B of Annex XIV and the post-market
        surveillance plan referred to in Article 84.
        For class III devices and implantable devices, the PMCF evaluation report and, if
        indicated, the summary of safety and clinical performance referred to in Article 32 shall be
        updated at least annually with such data.
12.     The clinical evaluation, its results and the clinical evidence derived from it shall be
        documented in a clinical evaluation report as referred to in Section 4 of Annex XIV,
        which, except for custom-made devices, shall be part of the technical documentation
        referred to in Annex II relating to the device concerned.
13.     Where necessary to ensure the uniform application of Annex XIV, the Commission may,
        having due regard to technical and scientific progress, adopt implementing acts to the
        extent necessary to resolve issues of divergent interpretation and of practical application.
        Those implementing acts shall be adopted in accordance with the examination procedure
        referred to in Article 114(3).
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 ---pagebreak---                                               Article 62
                      General requirements regarding clinical investigations
                          conducted to demonstrate conformity of devices
1.      Clinical investigations shall be designed, authorised, conducted, recorded and reported in
        accordance with the provisions of this Article and of Articles 63 to 80, the acts adopted
        pursuant to Article 81, and Annex XV, where carried out as part of the clinical evaluation
        for conformity assessment purposes, for one or more of the following purposes:
        (a)   to establish and verify that, under normal conditions of use, a device is designed,
              manufactured and packaged in such a way that it is suitable for one or more of the
              specific purposes listed in point (1) of Article 2, and achieves the performance
              intended as specified by its manufacturer;
        (b)   to establish and verify the clinical benefits of a device as specified by its
              manufacturer;
        (c)   to establish and verify the clinical safety of the device and to determine any
              undesirable side-effects, under normal conditions of use of the device, and assess
              whether they constitute acceptable risks when weighed against the benefits to be
              achieved by the device.
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 ---pagebreak--- 2.      Where the sponsor of a clinical investigation is not established in the Union, that sponsor
        shall ensure that a natural or legal person is established in the Union as its legal
        representative. Such legal representative shall be responsible for ensuring compliance with
        the sponsor's obligations pursuant to this Regulation, and shall be the addressee for all
        communications with the sponsor provided for in this Regulation. Any communication
        with that legal representative shall be deemed to be a communication with the sponsor.
        Member States may choose not to apply the first subparagraph to clinical investigations to
        be conducted solely on their territory, or on their territory and the territory of a third
        country, provided that they ensure that the sponsor establishes at least a contact person on
        their territory in respect of that clinical investigation who shall be the addressee for all
        communications with the sponsor provided for in this Regulation.
3.      Clinical investigations shall be designed and conducted in such a way that the rights,
        safety, dignity and well-being of the subjects participating in a clinical investigation are
        protected and prevail over all other interests and the clinical data generated are
        scientifically valid, reliable and robust.
        Clinical investigations shall be subject to scientific and ethical review. The ethical review
        shall be performed by an ethics committee in accordance with national law. Member States
        shall ensure that the procedures for review by ethics committees are compatible with the
        procedures set out in this Regulation for the assessment of the application for authorisation
        of a clinical investigation. At least one lay person shall participate in the ethical review.
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 ---pagebreak--- 4.      A clinical investigation as referred to in paragraph 1 may be conducted only where all of
        the following conditions are met:
        (a)   the clinical investigation is the subject of an authorisation by the Member State(s) in
              which the clinical investigation is to be conducted, in accordance with this
              Regulation, unless otherwise stated;
        (b)   an ethics committee, set up in accordance with national law, has not issued a
              negative opinion in relation to the clinical investigation, which is valid for that entire
              Member State under its national law;
        (c)   the sponsor, or its legal representative or a contact person pursuant to paragraph 2, is
              established in the Union;
        (d)   vulnerable populations and subjects are appropriately protected in accordance with
              Articles 64 to 68;
        (e)   the anticipated benefits to the subjects or to public health justify the foreseeable risks
              and inconveniences and compliance with this condition is constantly monitored;
        (f)   the subject or, where the subject is not able to give informed consent, his or her
              legally designated representative has given informed consent in accordance with
              Article 63;
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 ---pagebreak---         (g) the subject or, where the subject is not able to give informed consent, his or her
            legally designated representative, has been provided with the contact details of an
            entity where further information can be received in case of need;
        (h) the rights of the subject to physical and mental integrity, to privacy and to the
            protection of the data concerning him or her in accordance with Directive 95/46/EC
            are safeguarded;
        (i) the clinical investigation has been designed to involve as little pain, discomfort, fear
            and any other foreseeable risk as possible for the subjects, and both the risk threshold
            and the degree of distress are specifically defined in the clinical investigation plan
            and constantly monitored;
        (j) the medical care provided to the subjects is the responsibility of an appropriately
            qualified medical doctor or, where appropriate, a qualified dental practitioner or any
            other person entitled by national law to provide the relevant patient care under
            clinical investigation conditions;
        (k) no undue influence, including that of a financial nature, is exerted on the subject, or,
            where applicable, on his or her legally designated representatives, to participate in
            the clinical investigation;
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 ---pagebreak---         (l)    the investigational device(s) in question conform(s) to the applicable general safety
               and performance requirements set out in Annex I apart from the aspects covered by
               the clinical investigation and that, with regard to those aspects, every precaution has
               been taken to protect the health and safety of the subjects. This includes, where
               appropriate, technical and biological safety testing and pre-clinical evaluation, as
               well as provisions in the field of occupational safety and accident prevention, taking
               into consideration the state of the art;
        (m) the requirements of Annex XV are fulfilled.
5.      Any subject, or, where the subject is not able to give informed consent, his or her legally
        designated representative, may, without any resulting detriment and without having to
        provide any justification, withdraw from the clinical investigation at any time by revoking
        his or her informed consent. Without prejudice to Directive 95/46/EC, the withdrawal of
        the informed consent shall not affect the activities already carried out and the use of data
        obtained based on informed consent before its withdrawal.
6.      The investigator shall be a person exercising a profession which is recognised in the
        Member State concerned as qualifying for the role of investigator on account of having the
        necessary scientific knowledge and experience in patient care. Other personnel involved in
        conducting a clinical investigation shall be suitably qualified, by education, training or
        experience in the relevant medical field and in clinical research methodology, to perform
        their tasks.
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 ---pagebreak--- 7.      The facilities where the clinical investigation is to be conducted shall be suitable for the
        clinical investigation and shall be similar to the facilities where the device is intended to be
        used.
                                               Article 63
                                           Informed consent
1.      Informed consent shall be written, dated and signed by the person performing the interview
        referred to in point (c) of paragraph 2, and by the subject or, where the subject is not able
        to give informed consent, his or her legally designated representative after having been
        duly informed in accordance with paragraph 2. Where the subject is unable to write,
        consent may be given and recorded through appropriate alternative means in the presence
        of at least one impartial witness. In that case, the witness shall sign and date the informed
        consent document. The subject or, where the subject is not able to give informed consent,
        his or her legally designated representative shall be provided with a copy of the document
        or the record, as appropriate, by which informed consent has been given. The informed
        consent shall be documented. Adequate time shall be given for the subject or his or her
        legally designated representative to consider his or her decision to participate in the clinical
        investigation.
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 ---pagebreak--- 2.      Information given to the subject or, where the subject is not able to give informed consent,
        his or her legally designated representative for the purposes of obtaining his or her
        informed consent shall:
        (a)   enable the subject or his or her legally designated representative to understand:
              (i)    the nature, objectives, benefits, implications, risks and inconveniences of the
                     clinical investigations;
              (ii)   the subject's rights and guarantees regarding his or her protection, in particular
                     his or her right to refuse to participate in and the right to withdraw from the
                     clinical investigation at any time without any resulting detriment and without
                     having to provide any justification;
              (iii) the conditions under which the clinical investigations is to be conducted,
                     including the expected duration of the subject's participation in the clinical
                     investigation; and
              (iv) the possible treatment alternatives, including the follow-up measures if the
                     participation of the subject in the clinical investigation is discontinued;
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 ---pagebreak---         (b)   be kept comprehensive, concise, clear, relevant, and understandable to the subject or
              his or her legally designated representative;
        (c)   be provided in a prior interview with a member of the investigating team who is
              appropriately qualified under national law;
        (d)   include information about the applicable damage compensation system referred to in
              Article 69; and
        (e)   include the Union-wide unique single identification number of the clinical
              investigation referred to in Article 70(1) and information about the availability of the
              clinical investigation results in accordance with paragraph 6 of this Article.
3.      The information referred to in paragraph 2 shall be prepared in writing and be available to
        the subject or, where the subject is not able to give informed consent, his or her legally
        designated representative.
4.      In the interview referred to in point (c) of paragraph 2, special attention shall be paid to the
        information needs of specific patient populations and of individual subjects, as well as to
        the methods used to give the information.
5.      In the interview referred to in point (c) of paragraph 2, it shall be verified that the subject
        has understood the information.
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 ---pagebreak--- 6.      The subject shall be informed that a clinical investigation report and a summary presented
        in terms understandable to the intended user will be made available pursuant to
        Article 77(5) in the electronic system on clinical investigations referred to in Article 73
        irrespective of the outcome of the clinical investigation, and shall be informed, to the
        extent possible, when they have become available.
7.      This Regulation is without prejudice to national law requiring that, in addition to the
        informed consent given by the legally designated representative, a minor who is capable of
        forming an opinion and assessing the information given to him or her, shall also assent in
        order to participate in a clinical investigation.
                                               Article 64
                          Clinical investigations on incapacitated subjects
1.      In the case of incapacitated subjects who have not given, or have not refused to give,
        informed consent before the onset of their incapacity, a clinical investigation may be
        conducted only where, in addition to the conditions set out in Article 62(4), all of the
        following conditions are met:
        (a)   the informed consent of their legally designated representative has been obtained;
        (b)   the incapacitated subjects have received the information referred to in Article 63(2)
              in a way that is adequate in view of their capacity to understand it;
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 ---pagebreak---         (c)  the explicit wish of an incapacitated subject who is capable of forming an opinion
             and assessing the information referred to in Article 63(2) to refuse participation in, or
             to withdraw from, the clinical investigation at any time, is respected by the
             investigator;
        (d)  no incentives or financial inducements are given to subjects or their legally
             designated representatives, except for compensation for expenses and loss of
             earnings directly related to the participation in the clinical investigation;
        (e)  the clinical investigation is essential with respect to incapacitated subjects and data
             of comparable validity cannot be obtained in clinical investigations on persons able
             to give informed consent, or by other research methods;
        (f)  the clinical investigation relates directly to a medical condition from which the
             subject suffers;
        (g)  there are scientific grounds for expecting that participation in the clinical
             investigation will produce a direct benefit to the incapacitated subject outweighing
             the risks and burdens involved.
2.      The subject shall as far as possible take part in the informed consent procedure.
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 ---pagebreak---                                                  Article 65
                                     Clinical investigations on minors
A clinical investigation on minors may be conducted only where, in addition to the conditions set
out in Article 62(4), all of the following conditions are met:
(a)      the informed consent of their legally designated representative has been obtained;
(b)      the minors have received the information referred to in Article 63(2) in a way adapted to
         their age and mental maturity and from investigators or members of the investigating team
         who are trained or experienced in working with children;
(c)      the explicit wish of a minor who is capable of forming an opinion and assessing the
         information referred to in Article 63(2) to refuse participation in, or to withdraw from, the
         clinical investigation at any time, is respected by the investigator;
(d)      no incentives or financial inducements are given to the subject or his or her legally
         designated representative except for compensation for expenses and loss of earnings
         directly related to the participation in the clinical investigation;
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 ---pagebreak--- (e)     the clinical investigation is intended to investigate treatments for a medical condition that
        only occurs in minors or the clinical investigation is essential with respect to minors to
        validate data obtained in clinical investigations on persons able to give informed consent or
        by other research methods;
(f)     the clinical investigation either relates directly to a medical condition from which the
        minor concerned suffers or is of such a nature that it can only be carried out on minors;
(g)     there are scientific grounds for expecting that participation in the clinical investigation will
        produce a direct benefit to the minor subject outweighing the risks and burdens involved;
(h)     the minor shall take part in the informed consent procedure in a way adapted to his or her
        age and mental maturity;
(i)     if during a clinical investigation the minor reaches the age of legal competence to give
        informed consent as defined in national law, his or her express informed consent shall be
        obtained before that subject can continue to participate in the clinical investigation.
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 ---pagebreak---                                                 Article 66
                      Clinical investigations on pregnant or breastfeeding women
A clinical investigation on pregnant or breastfeeding women may be conducted only where, in
addition to the conditions set out in Article 62(4), all of the following conditions are met:
(a)       the clinical investigation has the potential to produce a direct benefit for the pregnant or
          breastfeeding woman concerned, or her embryo, foetus or child after birth, outweighing the
          risks and burdens involved;
(b)       where research is undertaken on breastfeeding women, particular care is taken to avoid any
          adverse impact on the health of the child;
(c)       no incentives or financial inducements are given to the subject except for compensation for
          expenses and loss of earnings directly related to the participation in the clinical
          investigation.
                                                Article 67
                                      Additional national measures
Member States may maintain additional measures regarding persons performing mandatory military
service, persons deprived of liberty, persons who, due to a judicial decision, cannot take part in
clinical investigations, or persons in residential care institutions.
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 ---pagebreak---                                                Article 68
                            Clinical investigations in emergency situations
1.      By way of derogation from point (f) of Article 62(4), from points (a) and (b) of
        Article 64(1) and from points (a) and (b) of Article 65, informed consent to participate in a
        clinical investigation may be obtained, and information on the clinical investigation may
        be given, after the decision to include the subject in the clinical investigation, provided that
        that decision is taken at the time of the first intervention on the subject, in accordance with
        the clinical investigation plan for that clinical investigation and that all of the following
        conditions are fulfilled:
        (a)    due to the urgency of the situation, caused by a sudden life-threatening or other
               sudden serious medical condition, the subject is unable to provide prior informed
               consent and to receive prior information on the clinical investigation;
        (b)    there are scientific grounds to expect that participation of the subject in the clinical
               investigation will have the potential to produce a direct clinically relevant benefit for
               the subject resulting in a measurable health-related improvement alleviating the
               suffering and/or improving the health of the subject, or in the diagnosis of its
               condition;
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 ---pagebreak---         (c)    it is not possible within the therapeutic window to supply all prior information to and
               obtain prior informed consent from his or her legally designated representative;
        (d)    the investigator certifies that he or she is not aware of any objections to participate in
               the clinical investigation previously expressed by the subject;
        (e)    the clinical investigation relates directly to the subject's medical condition because of
               which it is not possible within the therapeutic window to obtain prior informed
               consent from the subject or from his or her legally designated representative and to
               supply prior information, and the clinical investigation is of such a nature that it may
               be conducted exclusively in emergency situations;
        (f)    the clinical investigation poses a minimal risk to, and imposes a minimal burden on,
               the subject in comparison with the standard treatment of the subject's condition.
2.      Following an intervention pursuant to paragraph 1 of this Article, informed consent in
        accordance with Article 63 shall be sought to continue the participation of the subject in
        the clinical investigation, and information on the clinical investigation shall be given, in
        accordance with the following requirements:
        (a)    regarding incapacitated subjects and minors, the informed consent shall be sought by
               the investigator from his or her legally designated representative without undue delay
               and the information referred to in Article 63(2) shall be given as soon as possible to
               the subject and to his or her legally designated representative;
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 ---pagebreak---         (b)    regarding other subjects, the informed consent shall be sought by the investigator
               without undue delay from the subject or his or her legally designated representative,
               whichever can be done sooner, and the information referred to in Article 63(2) shall
               be given as soon as possible to the subject or his or her legally designated
               representative, as applicable.
        For the purposes of point (b) where informed consent has been obtained from the legally
        designated representative, informed consent to continue the participation in the clinical
        investigation shall be obtained from the subject as soon as he or she is capable of giving
        informed consent.
3.      If the subject or, where applicable, his or her legally designated representative does not
        give consent, he or she shall be informed of the right to object to the use of data obtained
        from the clinical investigation.
                                               Article 69
                                        Damage compensation
1.      Member States shall ensure that systems for compensation for any damage suffered by a
        subject resulting from participation in a clinical investigation conducted on their territory
        are in place in the form of insurance, a guarantee, or a similar arrangement that is
        equivalent as regards its purpose and which is appropriate to the nature and the extent of
        the risk.
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 ---pagebreak--- 2.      The sponsor and the investigator shall make use of the system referred to in paragraph 1 in
        the form appropriate for the Member State in which the clinical investigation is conducted.
                                              Article 70
                                Application for clinical investigations
1.      The sponsor of a clinical investigation shall submit an application to the Member State(s)
        in which the clinical investigation is to be conducted (referred to for the purposes of this
        Article as 'Member State concerned') accompanied by the documentation referred to in
        Chapter II of Annex XV.
        The application shall be submitted by means of the electronic system referred to in
        Article 73, which shall generate a Union-wide unique single identification number for the
        clinical investigation which shall be used for all relevant communication in relation to that
        clinical investigation. Within ten days of it receiving the application, the Member State
        concerned shall notify the sponsor as to whether the clinical investigation falls within the
        scope of this Regulation and as to whether the application dossier is complete in
        accordance with Chapter II of Annex XV.
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 ---pagebreak--- 2.      Within one week of any change occurring in relation to the documentation referred to in
        Chapter II of Annex XV, the sponsor shall update the relevant data in the electronic system
        referred to in Article 73 and make that change to the documentation clearly identifiable.
        The Member State concerned shall be notified of the update by means of that electronic
        system.
3.      Where the Member State concerned finds that the clinical investigation applied for does
        not fall within the scope of this Regulation or that the application dossier is not complete, it
        shall inform the sponsor thereof and shall set a time limit of maximum ten days for the
        sponsor to comment or to complete the application by means of the electronic system
        referred to in Article 73. The Member State concerned may extend this period by a
        maximum of 20 days where appropriate.
        Where the sponsor has not provided comments nor completed the application within the
        time limit referred to in the first subparagraph, the application shall be deemed to have
        lapsed. Where the sponsor considers the application does fall under the scope of this
        Regulation and/or is complete but the Member State concerned does not, the application
        shall be considered to have been rejected. The Member State concerned shall provide for
        an appeal procedure in respect of such refusal.
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 ---pagebreak---         The Member State concerned shall notify the sponsor within five days of receipt of the
        comments or of the requested additional information, whether the clinical investigation is
        considered as falling within the scope of this Regulation and the application is complete.
4.      The Member State concerned may also extend the period referred to in paragraph 1 and 3
        each by a further five days.
5.      For the purposes of this Chapter, the date on which the sponsor is notified in accordance
        with paragraph 1 or 3 shall be the validation date of the application. Where the sponsor is
        not notified, the validation date shall be the last day of the time periods referred to in
        paragraphs 1, 3 and 4 respectively.
6.      During the period when the application is being assessed, the Member State may request
        additional information from the sponsor. The expiry of the period laid down in point (b) of
        paragraph 7 shall be suspended from the date of the first request until such time as the
        additional information has been received.
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 ---pagebreak--- 7.      The sponsor may start the clinical investigation in the following circumstances:
        (a)   in the case of investigational class I devices or in the case of non-invasive class IIa
              and class IIb devices, unless otherwise stated by national law, immediately after the
              validation date of the application pursuant to paragraph 5, and provided that a
              negative opinion which is valid for the entire Member State, under national law, has
              not been issued by an ethics committee in the Member State concerned in respect of
              the clinical investigation;
        (b)   in the case of investigational devices, other than those referred to in point (a), as soon
              as the Member State concerned has notified the sponsor of its authorisation, and
              provided that a negative opinion which is valid for the entire Member State, under
              national law, has not been issued by an ethics committee in the Member State
              concerned in respect of the clinical investigation. The Member State shall notify the
              sponsor of the authorisation within 45 days of the validation date referred to in
              paragraph 5. The Member State may extend this period by a further 20 days for the
              purpose of consulting with experts.
8.      The Commission is empowered to adopt delegated acts in accordance with Article 115
        amending, in the light of technical progress and global regulatory developments, the
        requirements laid down in Chapter II of Annex XV.
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 ---pagebreak--- 9.      In order to ensure the uniform application of the requirements laid down in Chapter II of
        Annex XV, the Commission may adopt implementing acts to the extent necessary to
        resolve issues of divergent interpretation and of practical application. Those implementing
        acts shall be adopted in accordance with the examination procedure referred to in
        Article 114(3).
                                              Article 71
                                   Assessment by Member States
1.      Member States shall ensure that the persons validating and assessing the application, or
        deciding on it, do not have conflicts of interest, are independent of the sponsor, the
        investigators involved and of natural or legal persons financing the clinical investigation,
        as well as free of any other undue influence.
2.      Member States shall ensure that the assessment is done jointly by an appropriate number of
        persons who collectively have the necessary qualifications and experience.
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 ---pagebreak--- 3.      Member States shall assess whether the clinical investigation is designed in such a way that
        potential remaining risks to subjects or third persons, after risk minimization, are justified,
        when weighed against the clinical benefits to be expected. They shall, while taking into
        account applicable CS or harmonised standards, examine in particular:
        (a)   the demonstration of compliance of the investigational device(s) with the applicable
              general safety and performance requirements, apart from the aspects covered by the
              clinical investigation, and whether, with regard to those aspects, every precaution has
              been taken to protect the health and safety of the subjects. This includes, where
              appropriate, assurance of technical and biological safety testing and pre-clinical
              evaluation;
        (b)   whether the risk-minimisation solutions employed by the sponsor are described in
              harmonised standards and, in those cases where the sponsor does not use harmonised
              standards, whether the risk-minimisation solutions provide a level of protection that
              is equivalent to that provided by harmonised standards;
        (c)   whether the measures planned for the safe installation, putting into service and
             maintenance of the investigational device are adequate;
        (d)   the reliability and robustness of the data generated in the clinical investigation, taking
             account of statistical approaches, design of the investigation and methodological
             aspects, including sample size, comparator and endpoints;
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 ---pagebreak---         (e)    whether the requirements of Annex XV are met;
        (f)    in the case of devices for sterile use, evidence of the validation of the manufacturer's
               sterilisation procedures or information on the reconditioning and sterilisation
               procedures which have to be conducted by the investigation site;
        (g)    the demonstration of the safety, quality and usefulness of any components of animal
               or human origin or of substances, which may be considered medicinal products in
               accordance with Directive 2001/83/EC.
4.      Member States shall refuse the authorisation of the clinical investigation if:
        (a)    the application dossier submitted pursuant to Article 70(1) remains incomplete;
        (b)    the device or the submitted documents, especially the investigation plan and the
               investigator's brochure, do not correspond to the state of scientific knowledge, and
               the clinical investigation, in particular, is not suitable for providing evidence for the
               safety, performance characteristics or benefit of the device on subjects or patients,
        (c)    the requirements of Article 62 are not met, or
        (d)    any assessment under paragraph 3 is negative.
        Member States shall provide for an appeal procedure in respect of a refusal pursuant to the
        first subparagraph.
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 ---pagebreak---                                                 Article 72
                                  Conduct of a clinical investigation
1.      The sponsor and the investigator shall ensure that the clinical investigation is conducted in
        accordance with the approved clinical investigation plan.
2.      In order to verify that the rights, safety and well-being of subjects are protected, that the
        reported data are reliable and robust, and that the conduct of the clinical investigation is in
        compliance with the requirements of this Regulation, the sponsor shall ensure adequate
        monitoring of the conduct of a clinical investigation. The extent and nature of the
        monitoring shall be determined by the sponsor on the basis of an assessment that takes into
        consideration all characteristics of the clinical investigation including the following:
        (a)   the objective and methodology of the clinical investigation; and
        (b)   the degree of deviation of the intervention from normal clinical practice.
3.      All clinical investigation information shall be recorded, processed, handled, and stored by
        the sponsor or investigator, as applicable, in such a way that it can be accurately reported,
        interpreted and verified while the confidentiality of records and the personal data of the
        subjects remain protected in accordance with the applicable law on personal data
        protection.
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 ---pagebreak--- 4.      Appropriate technical and organisational measures shall be implemented to protect
        information and personal data processed against unauthorised or unlawful access,
        disclosure, dissemination, alteration, or destruction or accidental loss, in particular where
        the processing involves transmission over a network.
5.      Member States shall inspect, at an appropriate level, investigation site(s) to check that
        clinical investigations are conducted in accordance with the requirements of this
        Regulation and with the approved investigation plan.
6.      The sponsor shall establish a procedure for emergency situations which enables the
        immediate identification and, where necessary, an immediate recall of the devices used in
        the investigation.
                                               Article 73
                             Electronic system on clinical investigations
1.      The Commission shall, in collaboration with the Member States, set up, manage and
        maintain an electronic system:
        (a)   to create the single identification numbers for clinical investigations referred to in
              Article 70(1);
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 ---pagebreak---         (b)  to be used as an entry point for the submission of all applications or notifications for
             clinical investigations referred to in Articles 70, 74, 75 and 78 and for all other
             submission of data, or processing of data in this context;
        (c)  for the exchange of information relating to clinical investigations in accordance with
             this Regulation between the Member States and between them and the Commission
             including the exchange of information referred to in Articles 70 and 76;
        (d)  for information to be provided by the sponsor in accordance with Article 77,
             including the clinical investigation report and its summary as required in paragraph 5
             of that Article;
        (e)  for reporting on serious adverse events and device deficiencies and related updates
             referred to in Article 80.
2.      When setting up the electronic system referred in paragraph 1 of this Article, the
        Commission shall ensure that it is interoperable with the EU database for clinical trials on
        medicinal products for human use set up in accordance with Article 81 of
        Regulation (EU) No 536/2014 of the European Parliament and of the Council 1 as concerns
        combined clinical investigations of devices with a clinical trial under that Regulation.
1
      Regulation (EU) No 536/2014 of the European Parliament and of the Council of
      16 April 2014 on clinical trials on medicinal products for human use, and repealing
      Directive 2001/20/EC (OJ L 158, 27.5.2014, p. 1).
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 ---pagebreak--- 3.      The information referred to in point (c) of paragraph 1 shall only be accessible to the
        Member States and the Commission. The information referred to in the other points of that
        paragraph shall be accessible to the public, unless, for all or parts of that information,
        confidentiality of the information is justified on any of the following grounds:
        (a)    protection of personal data in accordance with Regulation (EC) No 45/2001;
        (b)    protection of commercially confidential information, especially in the investigators
               brochure, in particular through taking into account the status of the conformity
               assessment for the device, unless there is an overriding public interest in disclosure;
        (c)    effective supervision of the conduct of the clinical investigation by the
               Member State(s) concerned.
4.      No personal data of subjects shall be publicly available.
5.      The user interface of the electronic system referred to in paragraph 1 shall be available in
        all official languages of the Union.
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 ---pagebreak---                                               Article 74
                 Clinical investigations regarding devices bearing the CE marking
1.      Where a clinical investigation is to be conducted to further assess, within the scope of its
        intended purpose, a device which already bears the CE marking in accordance with
        Article 20(1), ('PMCF investigation'), and where the investigation would involve
        submitting subjects to procedures additional to those performed under the normal
        conditions of use of the device and those additional procedures are invasive or
        burdensome, the sponsor shall notify the Member States concerned at least 30 days prior to
        its commencement by means of the electronic system referred to in Article 73. The sponsor
        shall include the documentation referred to in Chapter II of Annex XV as part of the
        notification. Points (b) to (k) and (m) of Article 62(4), Article 75, Article 76, Article 77,
        Article 80(5) and the relevant provisions of Annex XV shall apply to PMCF investigations.
2.      Where a clinical investigation is to be conducted to assess, outside the scope of its intended
        purpose, a device which already bears the CE marking in accordance with Article 20(1),
        Articles 62 to 81 shall apply.
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 ---pagebreak---                                                 Article 75
                          Substantial modifications to clinical investigations
1.      If a sponsor intends to introduce modifications to a clinical investigation that are likely to
        have a substantial impact on the safety, health or rights of the subjects or on the robustness
        or reliability of the clinical data generated by the investigation, it shall notify, within one
        week, by means of the electronic system referred to in Article 73 the Member State(s) in
        which the clinical investigation is being or is to be conducted of the reasons for and the
        nature of those modifications. The sponsor shall include an updated version of the relevant
        documentation referred to in Chapter II of Annex XV as part of the notification. Changes
        to the relevant documentation shall be clearly identifiable.
2.      The Member State shall assess any substantial modification to the clinical investigation in
        accordance with the procedure laid down in Article 71.
3.      The sponsor may implement the modifications referred to in paragraph 1 at the earliest
        38 days after the notification referred to in that paragraph, unless:
        (a)    the Member State in which the clinical investigation is being or is to be conducted
               has notified the sponsor of its refusal based on the grounds referred to in
               Article 71(4) or on considerations of public health, subject and user safety or health,
               of public policy, or
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 ---pagebreak---         (b)    an ethics committee in that Member State has issued a negative opinion in relation to
               the substantial modification to the clinical investigation, which, in accordance with
               national law, is valid for that entire Member State.
4.      The Member State(s) concerned may extend the period referred to in paragraph 3 by a
        further seven days, for the purpose of consulting with experts.
                                                Article 76
                          Corrective measures to be taken by Member States
                          and information exchange between Member States
1.      Where a Member State in which a clinical investigation is being or is to be conducted has
        grounds for considering that the requirements set out in this Regulation are not met, it may
        take at least any of the following measures on its territory:
        (a)    revoke the authorisation for the clinical investigation;
        (b)    suspend or terminate the clinical investigation;
        (c)    require the sponsor to modify any aspect of the clinical investigation.
2.      Before the Member State concerned takes any of the measures referred to in paragraph 1 it
        shall, except where immediate action is required, ask the sponsor or the investigator or
        both for their opinion. That opinion shall be delivered within seven days.
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 ---pagebreak--- 3.      Where a Member State has taken a measure referred to in paragraph 1 of this Article or has
        refused a clinical investigation, or has been notified by the sponsor of the early termination
        of a clinical investigation on safety grounds, that Member State shall communicate the
        corresponding decision and the grounds therefor to all Member States and the Commission
        by means of the electronic system referred to in Article 73.
4.      Where an application is withdrawn by the sponsor prior to a decision by a Member State,
        that information shall be made available through the electronic system referred to in
        Article 73 to all Member States and the Commission.
                                                Article 77
                 Information from the sponsor at the end of a clinical investigation
                        or in the event of a temporary halt or early termination
1.      If the sponsor has temporarily halted a clinical investigation or has terminated a clinical
        investigation early, it shall inform within 15 days the Member State in which that clinical
        investigation has been temporarily halted or terminated early, through the electronic
        system referred to in Article 73, of the temporary halt or early termination, providing a
        justification. In the event that the sponsor has temporarily halted or terminated early the
        clinical investigation on safety grounds, it shall inform all Member States in which that
        clinical investigation is being conducted thereof within 24 hours.
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 ---pagebreak--- 2.      The end of a clinical investigation shall be deemed to coincide with the last visit of the last
        subject unless another point in time for such end is set out in the clinical investigation plan.
3.      The sponsor shall notify each Member State in which a clinical investigation was being
        conducted of the end of that clinical investigation in that Member State. That notification
        shall be made within 15 days of the end of the clinical investigation in relation to that
        Member State.
4.      If an investigation is conducted in more than one Member State, the sponsor shall notify all
        Member States in which that clinical investigation was conducted of the end of the clinical
        investigation in all Member States. That notification shall be made within 15 days of that
        end of the clinical investigation.
5.      Irrespective of the outcome of the clinical investigation, within one year of the end of the
        clinical investigation or within three months of the early termination or temporary halt, the
        sponsor shall submit to the Member States in which a clinical investigation was conducted
        a clinical investigation report as referred to in Section 2.8 of Chapter I and Section 7 of
        Chapter III of Annex XV.
        The clinical investigation report shall be accompanied by a summary presented in terms
        that are easily understandable to the intended user. Both the report and summary shall be
        submitted by the sponsor by means of the electronic system referred to in Article 73.
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 ---pagebreak---         Where, for scientific reasons, it is not possible to submit the clinical investigation report
        within one year of the end of the investigation, it shall be submitted as soon as it is
        available. In such case, the clinical investigation plan referred to in Section 3 of Chapter II
        of Annex XV shall specify when the results of the clinical investigation are going to be
        available, together with a justification.
6.      The Commission shall issue guidelines regarding the content and structure of the summary
        of the clinical investigation report.
        In addition, the Commission may issue guidelines for the formatting and sharing of raw
        data, for cases where the sponsor decides to share raw data on a voluntary basis. Those
        guidelines may take as a basis and adapt, where possible, existing guidelines for sharing of
        raw data in the field of clinical investigations.
7.      The summary and the clinical investigation report referred to in paragraph 5 of this
        Article shall become publicly accessible through the electronic system referred to in
        Article 73, at the latest when the device is registered in accordance with Article 29 and
        before it is placed on the market. In cases of early termination or temporary halt the
        summary and the report shall become publicly accessible immediately after submission.
        If the device is not registered in accordance with Article 29 within one year of the
        summary and the report having been entered into the electronic system pursuant to
        paragraph 5 of this Article, they shall become publicly accessible at that point in time.
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 ---pagebreak---                                               Article 78
                   Coordinated assessment procedure for clinical investigations
1.      By means of the electronic system referred to in Article 73, the sponsor of a clinical
        investigation to be conducted in more than one Member State may submit, for the purpose
        of Article 70, a single application that, upon receipt, is transmitted electronically to all
        Member States in which the clinical investigation is to be conducted.
2.      The sponsor shall propose in the single application referred to in paragraph 1 that one of
        the Member States in which the clinical investigation is to be conducted acts as
        coordinating Member State. The Member States in which the clinical investigation is to be
        conducted shall, within six days of submission of the application, agree on one of them
        taking the role of the coordinating Member State. If they do not agree on a coordinating
        Member State, the coordinating Member State proposed by the sponsor shall assume that
        role.
3.      Under the direction of the coordinating Member State referred to in paragraph 2, the
        Member States concerned shall coordinate their assessment of the application, in particular
        of the documentation referred to in Chapter II of Annex XV.
        However, the completeness of the documentation referred to in Sections 1.13, 3.1.3, 4.2,
        4.3 and 4.4 of Chapter II of Annex XV shall be assessed separately by each Member State
        concerned in accordance with Article 70(1) to (5).
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 ---pagebreak--- 4.      With regard to documentation other than that referred to in the second subparagraph of
        paragraph 3, the coordinating Member State shall:
        (a)  within six days of receipt of the single application, notify the sponsor that it is the
             coordinating Member State ('notification date');
        (b)  for the purpose of the validation of the application, take into account any
             considerations submitted within seven days of the notification date by any
             Member State concerned;
        (c)  within 10 days of the notification date, assess whether the clinical investigation falls
             within the scope of this Regulation and whether the application is complete, and shall
             notify the sponsor accordingly. Article 70(1) and (3) to (5) shall apply to the
             coordinating Member State in relation to that assessment;
        (d)  establish the results of its assessment in a draft assessment report to be transmitted
             within 26 days of the validation date to the Member States concerned. By day 38
             after the validation date the other Member States concerned shall transmit their
             comments and proposals on the draft assessment report and the underlying
             application to the coordinating Member State which shall take due account of those
             comments and proposals in its finalisation of the final assessment report, to be
             transmitted within 45 days of the validation date to the sponsor and the other
             Member States concerned.
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 ---pagebreak---         The final assessment report shall be taken into account by all Member States concerned
        when deciding on the sponsor's application in accordance with Article 70(7).
5.      As concerns the assessment of the documentation referred to in the second subparagraph of
        paragraph 3, each Member State concerned may request, on a single occasion, additional
        information from the sponsor. The sponsor shall submit the requested additional
        information within the period set by the Member State concerned which shall not exceed
        12 days from the receipt of the request. The expiry of the last deadline pursuant to point (d)
        of paragraph 4 shall be suspended from the date of the request until such time as the
        additional information has been received.
6.      For class IIb and class III devices, the coordinating Member State may also extend the
        periods referred to in paragraph 4 by a further 50 days, for the purpose of consulting with
        experts.
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 ---pagebreak--- 7.      The Commission may, by means of implementing acts, further specify the procedures and
        timescales for coordinated assessments to be taken into account by Member States
        concerned when deciding on the sponsor's application. Such implementing acts may also
        set out the procedures and timescales for coordinated assessment in the case of substantial
        modifications pursuant to paragraph 12 of this Article, in the case of reporting of adverse
        events pursuant to Article 80(4) and in the case of clinical investigations of combination
        products between medical devices and medicinal products, where the latter are under a
        concurrent coordinated assessment of a clinical trial under Regulation (EU) No 536/2014.
        Those implementing acts shall be adopted in accordance with the examination procedure
        referred to in Article 114(3).
8.      Where the conclusion of the coordinating Member State concerning the area of coordinated
        assessment is that the conduct of the clinical investigation is acceptable or acceptable
        subject to compliance with specific conditions, that conclusion shall be deemed to be the
        conclusion of all Member States concerned.
        Notwithstanding the first subparagraph, a Member State concerned may only disagree with
        the conclusion of the coordinating Member State concerning the area of coordinated
        assessment on the following grounds:
        (a)   when it considers that participation in the clinical investigation would lead to a
              subject receiving treatment inferior to that received in normal clinical practice in that
              Member State concerned;
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 ---pagebreak---         (b)   infringement of national law; or
        (c)   considerations as regards subject safety and data reliability and robustness submitted
              under point (b) of paragraph 4.
        Where one of the Member States concerned disagrees with the conclusion on the basis of
        the second subparagraph of this paragraph, it shall communicate its disagreement, together
        with a detailed justification, through the electronic system referred to in Article 73, to the
        Commission, to all other Member States concerned and to the sponsor.
9.      Where the conclusion of the coordinating Member State concerning the area of coordinated
        assessment is that the clinical investigation is not acceptable, that conclusion shall be
        deemed to be the conclusion of all Member States concerned.
10.     A Member State concerned shall refuse to authorise a clinical investigation if it disagrees
        with the conclusion of the coordinating Member State as regards any of the grounds
        referred to in the second subparagraph of paragraph 8, or if it finds, on duly justified
        grounds, that the aspects addressed in Sections 1.13, 3.1.3, 4.2, 4.3 and 4.4 of Chapter II of
        Annex XV are not complied with, or where an ethics committee has issued a negative
        opinion in relation to that clinical investigation, which is valid, in accordance with national
        law, for that entire Member State. That Member State shall provide for an appeal
        procedure in respect of such refusal.
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 ---pagebreak--- 11.     Each Member State concerned shall notify the sponsor through the electronic system
        referred to in Article 73 as to whether the clinical investigation is authorised, whether it is
        authorised subject to conditions, or whether authorisation has been refused. Notification
        shall be done by way of one single decision within five days of the transmission, pursuant
        to point (d) of paragraph 4, by the coordinating Member State of the final assessment
        report. Where an authorisation of a clinical investigation is subject to conditions, those
        conditions may only be such that, by their nature, they cannot be fulfilled at the time of
        that authorisation.
12.     Any substantial modifications as referred to in Article 75 shall be notified to the
        Member States concerned by means of the electronic system referred to in Article 73. Any
        assessment as to whether there are grounds for disagreement as referred to in the second
        subparagraph of paragraph 8 of this Article shall be carried out under the direction of the
        coordinating Member State, except for substantial modifications concerning Sections 1.13,
        3.1.3, 4.2, 4.3 and 4.4 of Chapter II of Annex XV, which shall be assessed separately by
        each Member State concerned.
13.     The Commission shall provide administrative support to the coordinating Member State in
        the accomplishment of its tasks under this Chapter.
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 ---pagebreak--- 14.      The procedure set out in this Article shall, until … [seven years after the date of
         application of this Regulation], be applied only by those of the Member States in which
         the clinical investigation is to be conducted which have agreed to apply it. After … [seven
         years after the date of application of this Regulation], all Member States shall be required
         to apply that procedure.
                                                 Article 79
                               Review of coordinated assessment procedure
By … [six years after the date of application of this Regulation], the Commission shall submit to
the European Parliament and to the Council a report on experience gained from the application of
Article 78 and, if necessary, propose a review of Article 78(14) and point (h) of Article 123(3).
                                                 Article 80
                                Recording and reporting of adverse events
                                 that occur during clinical investigations
1.       The sponsor shall fully record all of the following:
         (a)    any adverse event of a type identified in the clinical investigation plan as being
                critical to the evaluation of the results of that clinical investigation;
         (b)    any serious adverse event;
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 ---pagebreak---         (c)   any device deficiency that might have led to a serious adverse event if appropriate
              action had not been taken, intervention had not occurred, or circumstances had been
              less fortunate;
        (d)   any new findings in relation to any event referred to in points (a) to (c).
2.      The sponsor shall report, without delay to all Member States in which the clinical
        investigation is being conducted, all of the following by means of the electronic system
        referred to in Article 73:
        (a)   any serious adverse event that has a causal relationship with the investigational
              device, the comparator or the investigation procedure or where such causal
              relationship is reasonably possible;
        (b)   any device deficiency that might have led to a serious adverse event if appropriate
              action had not been taken, intervention had not occurred, or circumstances had been
              less fortunate;
        (c)   any new findings in relation to any event referred to in points (a) and (b).
        The time period for reporting shall take account of the severity of the event. Where
        necessary to ensure timely reporting, the sponsor may submit an initial report that is
        incomplete followed up by a complete report.
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 ---pagebreak---         Upon request by any Member State in which the clinical investigation is being conducted,
        the sponsor shall provide all information referred to in paragraph 1.
3.      The sponsor shall also report to the Member States in which the clinical investigation is
        being conducted any event referred to in paragraph 2 of this Article that occurred in third
        countries in which a clinical investigation is performed under the same clinical
        investigation plan as the one applying to a clinical investigation covered by this Regulation
        by means of the electronic system referred to in Article 73.
4.      In the case of a clinical investigation for which the sponsor has used the single application
        referred to in Article 78, the sponsor shall report any event as referred to in paragraph 2 of
        this Article by means of the electronic system referred to in Article 73. Upon receipt, this
        report shall be transmitted electronically to all Member States in which the clinical
        investigation is being conducted.
        Under the direction of the coordinating Member State referred to in Article 78(2), the
        Member States shall coordinate their assessment of serious adverse events and device
        deficiencies to determine whether to modify, suspend or terminate the clinical investigation
        or whether to revoke the authorisation for that clinical investigation.
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 ---pagebreak---         This paragraph shall not affect the rights of the other Member States to perform their own
        evaluation and to adopt measures in accordance with this Regulation in order to ensure the
        protection of public health and patient safety. The coordinating Member State and the
        Commission shall be kept informed of the outcome of any such evaluation and the
        adoption of any such measures.
5.      In the case of PMCF investigations referred to in Article 74(1), the provisions on vigilance
        laid down in Articles 87 to 90 and in the acts adopted pursuant to Article 91 shall apply
        instead of this Article.
6.      Notwithstanding paragraph 5, this Article shall apply where a causal relationship between
        the serious adverse event and the preceding investigational procedure has been established.
                                              Article 81
                                         Implementing acts
The Commission may, by means of implementing acts, establish the detailed arrangements and
procedural aspects necessary for the implementation of this Chapter as regards the following:
(a)     harmonised electronic forms for the application for clinical investigations and their
        assessment as referred to in Articles 70 and 78, taking into account specific categories or
        groups of devices;
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 ---pagebreak--- (b)     the functioning of the electronic system referred to in Article 73;
(c)     harmonised electronic forms for the notification of PMCF investigations as referred to in
        Article 74(1), and of substantial modifications as referred to in Article 75;
(d)     the exchange of information between Member States as referred to in Article 76;
(e)     harmonised electronic forms for the reporting of serious adverse events and device
        deficiencies as referred to in Article 80;
(f)     the timelines for the reporting of serious adverse events and device deficiencies, taking into
        account the severity of the event to be reported as referred to in Article 80;
(g)     uniform application of the requirements regarding the clinical evidence or data needed to
        demonstrate compliance with the general safety and performance requirements set out in
        Annex I.
The implementing acts referred to in the first paragraph shall be adopted in accordance with the
examination procedure referred to in Article 114(3).
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 ---pagebreak---                                                 Article 82
                          Requirements regarding other clinical investigations
1.      Clinical investigations, not performed pursuant to any of the purposes listed in
        Article 62(1), shall comply with the provisions of Article 62 (2) and (3), points (b), (c), (d),
        (f), (h), and (l) of Article 62(4) and Article 62(6).
2.      In order to protect the rights, safety, dignity and well-being of subjects and the scientific
        and ethical integrity of clinical investigations not performed for any of the purposes listed
        in Article 62(1), each Member State shall define any additional requirements for such
        investigations, as appropriate for each Member State concerned.
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 ---pagebreak---                                           Chapter VII
                         Post-market surveillance, vigilance
                                 and market surveillance
                                             SECTION 1
                               POST-MARKET SURVEILLANCE
                                              Article 83
                       Post-market surveillance system of the manufacturer
1.      For each device, manufacturers shall plan, establish, document, implement, maintain and
        update a post-market surveillance system in a manner that is proportionate to the risk class
        and appropriate for the type of device. That system shall be an integral part of the
        manufacturer's quality management system referred to in Article 10(9).
2.      The post-market surveillance system shall be suited to actively and systematically
        gathering, recording and analysing relevant data on the quality, performance and safety of
        a device throughout its entire lifetime, and to drawing the necessary conclusions and to
        determining, implementing and monitoring any preventive and corrective actions.
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 ---pagebreak--- 3.      Data gathered by the manufacturer's post-market surveillance system shall in particular be
        used:
        (a)   to update the benefit-risk determination and to improve the risk management as
              referred to in Chapter I of Annex I;
        (b)   to update the design and manufacturing information, the instructions for use and the
              labelling;
        (c)   to update the clinical evaluation;
        (d)   to update the summary of safety and clinical performance referred to in Article 32;
        (e)   for the identification of needs for preventive, corrective or field safety corrective
              action;
        (f)   for the identification of options to improve the usability, performance and safety of
              the device;
        (g)   when relevant, to contribute to the post-market surveillance of other devices; and
        (h)   to detect and report trends in accordance with Article 88.
        The technical documentation shall be updated accordingly.
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 ---pagebreak--- 4.       If, in the course of the post-market surveillance, a need for preventive or corrective action
         or both is identified, the manufacturer shall implement the appropriate measures and
         inform the competent authorities concerned and, where applicable, the notified body.
         Where a serious incident is identified or a field safety corrective action is implemented, it
         shall be reported in accordance with Article 87.
                                               Article 84
                                     Post-market surveillance plan
The post-market surveillance system referred to in Article 83 shall be based on a post-market
surveillance plan, the requirements for which are set out in Section 1.1 of Annex III. For devices
other than custom-made devices, the post-market surveillance plan shall be part of the technical
documentation specified in Annex II.
                                               Article 85
                                    Post-market surveillance report
Manufacturers of class I devices shall prepare a post-market surveillance report summarising the
results and conclusions of the analyses of the post-market surveillance data gathered as a result of
the post-market surveillance plan referred to in Article 84 together with a rationale and description
of any preventive and corrective actions taken. The report shall be updated when necessary and
made available to the competent authority upon request.
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 ---pagebreak---                                               Article 86
                                    Periodic safety update report
1.      Manufacturers of class IIa, class IIb and class III devices shall prepare a periodic safety
        update report ('PSUR') for each device and where relevant for each category or group of
        devices summarising the results and conclusions of the analyses of the post-market
        surveillance data gathered as a result of the post-market surveillance plan referred to in
        Article 84 together with a rationale and description of any preventive and corrective actions
        taken. Throughout the lifetime of the device concerned that PSUR shall set out:
        (a)   the conclusions of the benefit-risk determination;
        (b)   the main findings of the PMCF; and
        (c)   the volume of sales of the device and an estimate evaluation of the size and other
              characteristics of the population using the device and, where practicable, the usage
              frequency of the device.
        Manufacturers of class IIb and class III devices shall update the PSUR at least annually.
        That PSUR shall, except in the case of custom-made devices, be part of the technical
        documentation as specified in Annexes II and III.
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 ---pagebreak---         Manufacturers of class IIa devices shall update the PSUR when necessary and at least every
        two years. That PSUR shall, except in the case of custom-made devices, be part of the
        technical documentation as specified in Annexes II and III.
        For custom-made devices the PSUR shall be part of the documentation referred to in
        Section 2 of Annex XIII.
2.      For class III devices or implantable devices, manufacturers shall submit PSURs by means
        of the electronic system referred to in Article 92 to the notified body involved in the
        conformity assessment in accordance with Article 52. The notified body shall review the
        report and add its evaluation to that electronic system with details of any action taken.
        Such PSURs and the evaluation by the notified body shall be made available to competent
        authorities through that electronic system.
3.      For devices other than those referred to in paragraph 2, manufacturers shall make PSURs
        available to the notified body involved in the conformity assessment and, upon request, to
        competent authorities.
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 ---pagebreak---                                               SECTION 2
                                             VIGILANCE
                                               Article 87
                 Reporting of serious incidents and field safety corrective actions
1.      Manufacturers of devices made available on the Union market, other than investigational
        devices, shall report, to the relevant competent authorities, in accordance with
        Articles 92(5) and (7), the following:
        (a)   any serious incident involving devices made available on the Union market, except
              expected side-effects which are clearly documented in the product information and
              quantified in the technical documentation and are subject to trend reporting pursuant
              to Article 88;
        (b)   any field safety corrective action in respect of devices made available on the Union
              market, including any field safety corrective action undertaken in a third country in
              relation to a device which is also legally made available on the Union market, if the
              reason for the field safety corrective action is not limited to the device made
              available in the third country.
        The reports referred to in the first subparagraph shall be submitted through the electronic
        system referred to in Article 92.
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 ---pagebreak--- 2.      As a general rule, the time period for the reporting referred to in paragraph 1 shall take
        account of the severity of the serious incident.
3.      Manufacturers shall report any serious incident as referred to in point (a) of paragraph 1
        immediately after they have established the causal relationship between that incident and
        their device or that such causal relationship is reasonably possible and not later than
        15 days after they become aware of the incident.
4.      Notwithstanding paragraph 3, in the event of a serious public health threat the report
        referred to in paragraph 1 shall be provided immediately, and not later than 2 days after the
        manufacturer becomes aware of that threat.
5.      Notwithstanding paragraph 3, in the event of death or an unanticipated serious
        deterioration in a person's state of health the report shall be provided immediately after the
        manufacturer has established or as soon as it suspects a causal relationship between the
        device and the serious incident but not later than 10 days after the date on which the
        manufacturer becomes aware of the serious incident.
6.      Where necessary to ensure timely reporting, the manufacturer may submit an initial report
        that is incomplete followed up by a complete report.
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 ---pagebreak--- 7.      If, after becoming aware of a potentially reportable incident, the manufacturer is uncertain
        about whether the incident is reportable, it shall nevertheless submit a report within the
        timeframe required in accordance with paragraphs 2 to 5.
8.      Except in cases of urgency in which the manufacturer needs to undertake field safety
        corrective action immediately, the manufacturer shall, without undue delay, report the field
        safety corrective action referred to in point (b) of paragraph 1 in advance of the field safety
        corrective action being undertaken.
9.      For similar serious incidents that occur with the same device or device type and for which
        the root cause has been identified or a field safety corrective action implemented or where
        the incidents are common and well documented, the manufacturer may provide periodic
        summary reports instead of individual serious incident reports, on condition that the
        coordinating competent authority referred to in Article 89(9), in consultation with the
        competent authorities referred to in point (a) of Article 92(8), has agreed with the
        manufacturer on the format, content and frequency of the periodic summary reporting.
        Where a single competent authority is referred to in points (a) and (b) of Article 92(8), the
        manufacturer may provide periodic summary reports following agreement with that
        competent authority.
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 ---pagebreak--- 10.     The Member States shall take appropriate measures such as organising targeted
        information campaigns, to encourage and enable healthcare professionals, users and
        patients to report to the competent authorities suspected serious incidents referred to in
        point (a) of paragraph 1.
        The competent authorities shall record centrally at national level reports they receive from
        healthcare professionals, users and patients.
11.     Where a competent authority of a Member State obtains such reports on suspected serious
        incidents referred to in point (a) of paragraph 1 from healthcare professionals, users or
        patients, it shall take the necessary steps to ensure that the manufacturer of the device
        concerned is informed of the suspected serious incident without delay.
        Where the manufacturer of the device concerned considers that the incident is a serious
        incident, it shall provide a report in accordance with paragraphs 1 to 5 of this Article on
        that serious incident to the competent authority of the Member State in which that serious
        incident occurred and shall take the appropriate follow-up action in accordance with
        Article 89.
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 ---pagebreak---         Where the manufacturer of the device concerned considers that the incident is not a serious
        incident or is an expected undesirable side-effect, which will be covered by trend reporting
        in accordance with Article 88, it shall provide an explanatory statement. If the competent
        authority does not agree with the conclusion of the explanatory statement, it may require
        the manufacturer to provide a report in accordance with paragraphs 1 to 5 of this
        Article and require it to ensure that appropriate follow-up action is taken in accordance
        with Article 89.
                                                Article 88
                                            Trend reporting
1.      Manufacturers shall report by means of the electronic system referred to in Article 92 any
        statistically significant increase in the frequency or severity of incidents that are not serious
        incidents or that are expected undesirable side-effects that could have a significant impact
        on the benefit-risk analysis referred to in Sections 1 and 5 of Annex I and which have led
        or may lead to risks to the health or safety of patients, users or other persons that are
        unacceptable when weighed against the intended benefits. The significant increase shall be
        established in comparison to the foreseeable frequency or severity of such incidents in
        respect of the device, or category or group of devices, in question during a specific time
        period as specified in the technical documentation and product information.
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 ---pagebreak---         The manufacturer shall specify how to manage the incidents referred to in the first
        subparagraph and the methodology used for determining any statistically significant
        increase in the frequency or severity of such incidents, as well as the observation period, in
        the post-market surveillance plan referred to in Article 84.
2.      The competent authorities may conduct their own assessments on the trend reports referred
        to in paragraph 1 and require the manufacturer to adopt appropriate measures in
        accordance with this Regulation in order to ensure the protection of public health and
        patient safety. Each competent authority shall inform the Commission, the other competent
        authorities and the notified body that issued the certificate, of the results of such
        assessment and of the adoption of such measures.
                                              Article 89
                   Analysis of serious incidents and field safety corrective actions
1.      Following the reporting of a serious incident pursuant to Article 87(1), the manufacturer
        shall, without delay, perform the necessary investigations in relation to the serious incident
        and the devices concerned. This shall include a risk assessment of the incident and field
        safety corrective action taking into account criteria as referred to in paragraph 3 of this
        Article as appropriate.
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 ---pagebreak---         The manufacturer shall co-operate with the competent authorities and where relevant with
        the notified body concerned during the investigations referred to in the first
        subparagraph and shall not perform any investigation which involves altering the device or
        a sample of the batch concerned in a way which may affect any subsequent evaluation of
        the causes of the incident, prior to informing the competent authorities of such action.
2.      Member States shall take the necessary steps to ensure that any information regarding a
        serious incident that has occurred within their territory, or a field safety corrective action
        that has been or is to be undertaken within their territory, and that is brought to their
        knowledge in accordance with Article 87 is evaluated centrally at national level by their
        competent authority, if possible together with the manufacturer, and, where relevant, the
        notified body concerned.
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 ---pagebreak--- 3.      In the context of the evaluation referred to in paragraph 2, the competent authority shall
        evaluate the risks arising from the reported serious incident and evaluate any related field
        safety corrective actions, taking into account the protection of public health and criteria
        such as causality, detectability and probability of recurrence of the problem, frequency of
        use of the device, probability of occurrence of direct or indirect harm, the severity of that
        harm, the clinical benefit of the device, intended and potential users, and population
        affected. The competent authority shall also evaluate the adequacy of the field safety
        corrective action envisaged or undertaken by the manufacturer and the need for, and kind
        of, any other corrective action, in particular taking into account the principle of inherent
        safety contained in Annex I.
        Upon request by the national competent authority, manufacturers shall provide all
        documents necessary for the risk assessment.
4.      The competent authority shall monitor the manufacturer's investigation of a serious
        incident. Where necessary, a competent authority may intervene in a manufacturer's
        investigation or initiate an independent investigation.
5.      The manufacturer shall provide a final report to the competent authority setting out its
        findings from the investigation by means of the electronic system referred to in Article 92.
        The report shall set out conclusions and where relevant indicate corrective actions to be
        taken.
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 ---pagebreak--- 6.      In the case of devices referred to in the first subparagraph of Article 1(8) and where the
        serious incident or field safety corrective action may be related to a substance which, if
        used separately, would be considered to be a medicinal product, the evaluating competent
        authority or the coordinating competent authority referred to in paragraph 9 of this
        Article shall, inform the national competent authority or the EMA, depending on which
        issued the scientific opinion on that substance under Article 52(9), of that serious incident
        or field safety corrective action.
        In the case of devices covered by this Regulation in accordance with point (g) of
        Article 1(6) and where the serious incident or field safety corrective action may be related
        to the derivatives of tissues or cells of human origin utilised for the manufacture of the
        device, and in the case of devices falling under this Regulation pursuant to Article 1(10),
        the competent authority or the coordinating competent authority referred to in paragraph 9
        of this Article shall inform the competent authority for human tissues and cells that was
        consulted by the notified body in accordance with Article 52(10).
7.      After carrying out the evaluation in accordance with paragraph 3 of this Article, the
        evaluating competent authority shall, through the electronic system referred to in
        Article 92, inform, without delay, the other competent authorities of the corrective action
        taken or envisaged by the manufacturer or required of it to minimise the risk of recurrence
        of the serious incident, including information on the underlying events and the outcome of
        its assessment.
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 ---pagebreak--- 8.      The manufacturer shall ensure that information about the field safety corrective action
        taken is brought without delay to the attention of users of the device in question by means
        of a field safety notice. The field safety notice shall be edited in an official Union language
        or languages determined by the Member State in which the field safety corrective action is
        taken. Except in cases of urgency, the content of the draft field safety notice shall be
        submitted to the evaluating competent authority or, in the cases referred to in paragraph 9,
        to the coordinating competent authority to allow them to make comments. Unless duly
        justified by the situation of the individual Member State, the content of the field safety
        notice shall be consistent in all Member States.
        The field safety notice shall allow the correct identification of the device or devices
        involved, in particular by including the relevant UDIs, and the correct identification, in
        particular, by including the SRN, if already issued, of the manufacturer that has undertaken
        the field safety corrective action. The field safety notice shall explain, in a clear manner,
        without understating the level of risk, the reasons for the field safety corrective action with
        reference to the device malfunction and associated risks for patients, users or other
        persons, and shall clearly indicate all the actions to be taken by users.
        The manufacturer shall enter the field safety notice in the electronic system referred to in
        Article 92 through which that notice shall be accessible to the public.
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 ---pagebreak--- 9.      The competent authorities shall actively participate in a procedure in order to coordinate
        their assessments referred to in paragraph 3 in the following cases:
        (a)    where there is concern regarding a particular serious incident or cluster of serious
               incidents relating to the same device or type of device of the same manufacturer in
               more than one Member State;
        (b)    where the appropriateness of a field safety corrective action that is proposed by a
               manufacturer in more than one Member State is in question.
        That coordinated procedure shall cover the following:
        –      designation of a coordinating competent authority on a case by case basis, when
               required;
        –      defining the coordinated assessment process, including the tasks and responsibilities
               of the coordinating competent authority and the involvement of other competent
               authorities.
        Unless otherwise agreed between the competent authorities, the coordinating competent
        authority shall be the competent authority of the Member State in which the manufacturer
        has its registered place of business.
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 ---pagebreak---           The coordinating competent authority shall, through the electronic system referred to in
          Article 92, inform the manufacturer, the other competent authorities and the Commission
          that it has assumed the role of coordinating authority.
10.       The designation of a coordinating competent authority shall not affect the rights of the
          other competent authorities to perform their own assessment and to adopt measures in
          accordance with this Regulation in order to ensure the protection of public health and
          patient safety. The coordinating competent authority and the Commission shall be kept
          informed of the outcome of any such assessment and the adoption of any such measures.
11.       The Commission shall provide administrative support to the coordinating competent
          authority in the accomplishment of its tasks under this Chapter.
                                                Article 90
                                        Analysis of vigilance data
The Commission shall, in collaboration with the Member States, put in place systems and processes
to actively monitor the data available in the electronic system referred to in Article 92, in order to
identify trends, patterns or signals in the data that may reveal new risks or safety concerns.
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 ---pagebreak--- Where a previously unknown risk is identified or the frequency of an anticipated risk significantly
and adversely changes the benefit-risk determination, the competent authority or, where
appropriate, the coordinating competent authority shall inform the manufacturer, or where
applicable the authorised representative, which shall then take the necessary corrective actions.
                                               Article 91
                                          Implementing acts
The Commission may, by means of implementing acts, and after consultation of the MDCG, adopt
the detailed arrangements and procedural aspects necessary for the implementation of Articles 85
to 90 and 92 as regards the following:
(a)      the typology of serious incidents and field safety corrective actions in relation to specific
         devices, or categories or groups of devices;
(b)      the reporting of serious incidents and field safety corrective actions and field safety
         notices, and the provision of periodic summary reports, post-market surveillance reports,
         PSURs and trend reports by manufacturers as referred to in Articles 85, 86, 87, 88 and 89
         respectively;
(c)      standard structured forms for electronic and non-electronic reporting, including a minimum
         data set for reporting of suspected serious incidents by healthcare professionals, users and
         patients;
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 ---pagebreak--- (d)     timelines for the reporting of field safety corrective actions, and for the provision by
        manufacturers of periodic summary reports and trend reports, taking into account the
        severity of the incident to be reported as referred to in Article 87;
(e)     harmonised forms for the exchange of information between competent authorities as
        referred to in Article 89;
(f)     procedures for the designation of a coordinating competent authority; the coordinated
        evaluation process, including tasks and responsibilities of the coordinating competent
        authority and involvement of other competent authorities in this process.
The implementing acts referred to in the first paragraph shall be adopted in accordance with the
examination procedure referred to in Article 114(3).
                                               Article 92
                  Electronic system on vigilance and on post-market surveillance
1.      The Commission shall, in collaboration with the Member States, set up and manage an
        electronic system to collate and process the following information:
        (a)   t reports by manufacturers on serious incidents and field safety corrective actions
              referred to in Article 87(1) and Article 89(5);
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 ---pagebreak---         (b)    the periodic summary reports by manufacturers referred to in Article 87(9);
        (c)    the reports by manufacturers on trends referred to in Article 88;
        (d)    the PSURs referred to in Article 86;
        (e)    the field safety notices by manufacturers referred to in Article 89(8);
        (f)    the information to be exchanged between the competent authorities of the
               Member States and between them and the Commission in accordance with
               Article 89(7) and (9).
        That electronic system shall include relevant links to the UDI database.
2.      The information referred to in paragraph 1 of this Article shall be made available through
        the electronic system to the competent authorities of the Member States and to the
        Commission. The notified bodies shall also have access to that information to the extent
        that it relates to devices for which they issued a certificate in accordance with Article 53.
3.      The Commission shall ensure that healthcare professionals and the public have appropriate
        levels of access to the electronic system referred to in paragraph 1.
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 ---pagebreak--- 4.      On the basis of arrangements between the Commission and competent authorities of third
        countries or international organisations, the Commission may grant those competent
        authorities or international organisations access to the electronic system referred to in
        paragraph 1 at the appropriate level. Those arrangements shall be based on reciprocity and
        make provision for confidentiality and data protection equivalent to those applicable in the
        Union.
5.      The reports on serious incidents referred to in point (a) of Article 87(1) shall be
        automatically transmitted, upon receipt, via the electronic system referred to in paragraph 1
        of this Article, to the competent authority of the Member State in which the incident
        occurred.
6.      The trend reports referred to in Article 88(1) shall be automatically transmitted upon
        receipt via the electronic system referred to in paragraph 1 of this Article to the competent
        authorities of the Member State in which the incidents occurred.
7.      The reports on field safety corrective actions referred to in point (b) of Article 87(1) shall
        be automatically transmitted upon receipt via the electronic system referred to in
        paragraph 1 of this Article to the competent authorities of the following Member States:
        (a)    the Member States in which the field safety corrective action is being or is to be
               undertaken;
        (b)    the Member State in which the manufacturer has its registered place of business.
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 ---pagebreak--- 8.      The periodic summary reports referred to in Article 87(9) shall be automatically
        transmitted upon receipt via the electronic system referred to in paragraph 1 of this
        Article to the competent authority of:
        (a)   the Member State or Member States participating in the coordination procedure in
              accordance with Article 89(9) and which have agreed on the periodic summary
              report;
        (b)   the Member State in which the manufacturer has its registered place of business.
9.      The information referred to in paragraphs 5 to 8 of this Article shall be automatically
        transmitted, upon receipt, through the electronic system referred to in paragraph 1 of this
        Article, to the notified body that issued the certificate for the device in question in
        accordance with Article 56.
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 ---pagebreak---                                               SECTION 3
                                     MARKET SURVEILLANCE
                                                Article 93
                                     Market surveillance activities
1.      The competent authorities shall perform appropriate checks on the conformity
        characteristics and performance of devices including, where appropriate, a review of
        documentation and physical or laboratory checks on the basis of adequate samples. The
        competent authorities shall, in particular, take account of established principles regarding
        risk assessment and risk management, vigilance data and complaints.
2.      The competent authorities shall draw up annual surveillance activity plans and allocate a
        sufficient number of material and competent human resources in order to carry out those
        activities taking into account the European market surveillance program developed by the
        MDCG pursuant to Article 105 and local circumstances.
3.      In order to fulfil the obligations laid down in paragraph 1, the competent authorities:
        (a)   may require economic operators to, inter alia, make available the documentation and
              information necessary for the purpose of carrying out the authorities' activities and,
              where justified, to provide the necessary samples of devices or access to devices free
              of charge; and
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 ---pagebreak---         (b)   shall carry out both announced and, if necessary, unannounced inspections of the
              premises of economic operators, as well as suppliers and/or subcontractors, and,
              where necessary, at the facilities of professional users.
4.      The competent authorities shall prepare an annual summary of the results of their
        surveillance activities and make it accessible to other competent authorities by means of
        the electronic system referred to in Article 100.
5.      The competent authorities may confiscate, destroy or otherwise render inoperable devices
        that present an unacceptable risk or falsified devices where they deem it necessary to do so
        in the interests of the protection of public health.
6.      Following each inspection carried out for the purposes referred to in paragraph 1, the
        competent authority shall draw up a report on the findings of the inspection that concern
        compliance with the legal and technical requirements applicable under this Regulation. The
        report shall set out any corrective actions needed.
7.      The competent authority which carried out the inspection shall communicate the content of
        the report referred to in paragraph 6 of this Article to the economic operator that has been
        the subject of the inspection. Before adopting the final report, the competent authority shall
        give that economic operator the opportunity to submit comments. That final inspection
        report shall be entered in the electronic system provided for in Article 100.
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 ---pagebreak--- 8.      The Member States shall review and assess the functioning of their market surveillance
        activities. Such reviews and assessments shall be carried out at least every four years and
        the results thereof shall be communicated to the other Member States and the Commission.
        Each Member State shall make a summary of the results accessible to the public by means
        of the electronic system referred to in Article 100.
9.      The competent authorities of the Member States shall coordinate their market surveillance
        activities, cooperate with each other and share with each other and with the Commission
        the results thereof, to provide for a harmonised and high level of market surveillance in all
        Member States.
        Where appropriate, the competent authorities of the Member States shall agree on work-
        sharing, joint market surveillance activities and specialisation.
10.     Where more than one authority in a Member State is responsible for market surveillance
        and external border controls, those authorities shall cooperate with each other, by sharing
        information relevant to their role and functions.
11.     Where appropriate, the competent authorities of the Member States shall cooperate with
        the competent authorities of third countries with a view to exchanging information and
        technical support and promoting activities relating to market surveillance.
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 ---pagebreak---                                                Article 94
                             Evaluation of devices suspected of presenting
                             an unacceptable risk or other non-compliance
Where the competent authorities of a Member State, based on data obtained by vigilance or market
surveillance activities or on other information, have reason to believe that a device:
(a)      may present an unacceptable risk to the health or safety of patients, users or other persons,
         or to other aspects of the protection of public health; or
(b)      otherwise does not comply with the requirements laid down in this Regulation,
they shall carry out an evaluation of the device concerned covering all requirements laid down in
this Regulation relating to the risk presented by the device, or to any other non-compliance of the
device.
The relevant economic operators shall cooperate with the competent authorities.
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 ---pagebreak---                                                Article 95
                             Procedure for dealing with devices presenting
                                an unacceptable risk to health and safety
1.      Where, having performed an evaluation pursuant to Article 94, the competent authorities
        find that the device presents an unacceptable risk to the health or safety of patients, users
        or other persons, or to other aspects of the protection of public health, they shall without
        delay require the manufacturer of the devices concerned, its authorised representative and
        all other relevant economic operators to take all appropriate and duly justified corrective
        action to bring the device into compliance with the requirements of this Regulation relating
        to the risk presented by the device and, in a manner that is proportionate to the nature of
        the risk, to restrict the making available of the device on the market, to subject the making
        available of the device to specific requirements, to withdraw the device from the market, or
        to recall it, within a reasonable period that is clearly defined and communicated to the
        relevant economic operator.
2.      The competent authorities shall, without delay, notify the Commission, the other
        Member States and, where a certificate has been issued in accordance with Article 56 for
        the device concerned, the notified body that issued that certificate, of the results of the
        evaluation and of the actions which they have required the economic operators to take, by
        means of the electronic system referred to in Article 100.
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 ---pagebreak--- 3.      The economic operators as referred to in paragraph 1 shall without delay ensure that all
        appropriate corrective action is taken throughout the Union in respect of all the devices
        concerned that they have made available on the market.
4.      Where the economic operator as referred to in paragraph 1 does not take adequate
        corrective action within the period referred to in paragraph 1, the competent authorities
        shall take all appropriate measures to prohibit or restrict the making available of the device
        on their national market, to withdraw the device from that market or to recall it.
        The competent authorities shall notify the Commission, the other Member States and the
        notified body referred to in paragraph 2 of this Article, without delay, of those measures,
        by means of the electronic system referred to in Article 100.
5.      The notification referred to in paragraph 4 shall include all available details, in particular
        the data necessary for the identification and tracing of the non-compliant device, the origin
        of the device, the nature of and the reasons for the non-compliance alleged and the risk
        involved, the nature and duration of the national measures taken and the arguments put
        forward by the relevant economic operator.
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 ---pagebreak--- 6.      Member States other than the Member State initiating the procedure shall, without delay,
        inform the Commission and the other Member States, by means of the electronic system
        referred to in Article 100, of any additional relevant information at their disposal relating
        to the non-compliance of the device concerned and of any measures adopted by them in
        relation to the device concerned.
        In the event of disagreement with the notified national measure, they shall without delay
        inform the Commission and the other Member States of their objections, by means of the
        electronic system referred to in Article 100.
7.      Where, within two months of receipt of the notification referred to in paragraph 4, no
        objection has been raised by either a Member State or the Commission in respect of any
        measures taken by a Member State, those measures shall be deemed to be justified.
        In that case, all Member States shall ensure that corresponding appropriate restrictive or
        prohibitive measures, including withdrawing, recalling or limiting the availability of the
        device on their national market, are taken without delay in respect of the device concerned.
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 ---pagebreak---                                                Article 96
                     Procedure for evaluating national measures at Union level
1.      Where, within two months of receipt of the notification referred to in Article 95(4),
        objections are raised by a Member State against a measure taken by another Member State,
        or where the Commission considers the measure to be contrary to Union law, the
        Commission shall, after consulting the competent authorities concerned and, where
        necessary, the economic operators concerned, evaluate that national measure. On the basis
        of the results of that evaluation, the Commission may decide, by means of implementing
        acts, whether or not the national measure is justified. Those implementing acts shall be
        adopted in accordance with the examination procedure referred to in Article 114(3).
2.      Where the Commission considers the national measure to be justified as referred to in
        paragraph 1 of this Article, the second subparagraph of Article 95(7) shall apply. If the
        Commission considers the national measure to be unjustified, the Member State concerned
        shall withdraw the measure.
        Where the Commission does not adopt a decision pursuant to paragraph 1 of this
        Article within eight months of receipt of the notification referred to in Article 95(4), the
        national measure shall be considered to be justified.
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 ---pagebreak--- 3.      Where a Member State or the Commission consider that the risk to health and safety
        emanating from a device cannot be mitigated satisfactorily by means of measures taken by
        the Member State or Member States concerned, the Commission, at the request of a
        Member State or on its own initiative, may take, by means of implementing acts, the
        necessary and duly justified measures to ensure the protection of health and safety,
        including measures restricting or prohibiting the placing on the market and putting into
        service of the device concerned. Those implementing acts shall be adopted in accordance
        with the examination procedure referred to in Article 114(3).
                                              Article 97
                                        Other non-compliance
1.      Where, having performed an evaluation pursuant to Article 94, the competent authorities of
        a Member State find that a device does not comply with the requirements laid down in this
        Regulation but does not present an unacceptable risk to the health or safety of patients,
        users or other persons, or to other aspects of the protection of public health, they shall
        require the relevant economic operator to bring the non-compliance concerned to an end
        within a reasonable period that is clearly defined and communicated to the economic
        operator and that is proportionate to the non-compliance.
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 ---pagebreak--- 2.      Where the economic operator does not bring the non-compliance to an end within the
        period referred to in paragraph 1 of this Article, the Member State concerned shall without
        delay take all appropriate measures to restrict or prohibit the product being made available
        on the market or to ensure that it is recalled or withdrawn from the market. That
        Member State shall inform the Commission and the other Member States without delay of
        those measures, by means of the electronic system referred to in Article 100.
3.      In order to ensure the uniform application of this Article, the Commission may, by means
        of implementing acts, specify appropriate measures to be taken by competent authorities to
        address given types of non-compliance. Those implementing acts shall be adopted in
        accordance with the examination procedure referred to in Article 114(3).
                                               Article 98
                               Preventive health protection measures
1.      Where a Member State, after having performed an evaluation which indicates a potential
        risk related to a device or a specific category or group of devices, considers that, in order to
        protect the health and safety of patients, users or other persons or other aspects of public
        health, the making available on the market or putting into service of a device or a specific
        category or group of devices should be prohibited, restricted or made subject to particular
        requirements or that such device or category or group of devices should be withdrawn from
        the market or recalled, it may take any necessary and justified measures.
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 ---pagebreak--- 2.      The Member State referred to in paragraph 1 shall immediately notify the Commission and
        all other Member States, giving the reasons for its decision, by means of the electronic
        system referred to in Article 100.
3.      The Commission, in consultation with the MDCG and, where necessary, the economic
        operators concerned, shall assess the national measures taken. The Commission may
        decide, by means of implementing acts, whether the national measures are justified or not.
        In the absence of a Commission decision within six months of their notification, the
        national measures shall be considered to be justified. Those implementing acts shall be
        adopted in accordance with the examination procedure referred to in Article 114(3).
4.      Where the assessment referred to in paragraph 3 of this Article demonstrates that the
        making available on the market or putting into service of a device, specific category or
        group of devices should be prohibited, restricted or made subject to particular requirements
        or that such device or category or group of devices should be withdrawn from the market
        or recalled in all Member States in order to protect the health and safety of patients, users
        or other persons or other aspects of public health, the Commission may adopt
        implementing acts to take the necessary and duly justified measures. Those implementing
        acts shall be adopted in accordance with the examination procedure referred to in
        Article 114(3).
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 ---pagebreak---                                               Article 99
                                    Good administrative practice
1.      Any measure adopted by the competent authorities of the Member States pursuant to
        Articles 95 to 98 shall state the exact grounds on which it is based. Where such a measure
        is addressed to a specific economic operator, the competent authority shall notify without
        delay the economic operator concerned of that measure, and shall at the same time inform
        that economic operator of the remedies available under the law or the administrative
        practice of the Member State concerned and of the time limits to which such remedies are
        subject. Where the measure is of general applicability, it shall be appropriately published.
2.      Except in cases where immediate action is necessary for reasons of unacceptable risk to
        human health or safety, the economic operator concerned shall be given the opportunity to
        make submissions to the competent authority within an appropriate period of time that is
        clearly defined before any measure is adopted.
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 ---pagebreak---         Where action has been taken without the economic operator having had the opportunity to
        make submissions as referred to in the first subparagraph, it shall be given the opportunity
        to make submissions as soon as possible and the action taken shall be reviewed promptly
        thereafter.
3.      Any measure adopted shall be immediately withdrawn or amended upon the economic
        operator's demonstrating that it has taken effective corrective action and that the device is
        in compliance with the requirements of this Regulation.
4.      Where a measure adopted pursuant to Articles 95 to 98 concerns a device for which a
        notified body has been involved in the conformity assessment, the competent authorities
        shall by means of the electronic system referred to in Article 100 inform the relevant
        notified body and the authority responsible for the notified body of the measure taken.
                                              Article 100
                              Electronic system on market surveillance
1.      The Commission, in collaboration with the Member States, shall set up and manage an
        electronic system to collate and process the following information:
        (a)   summaries of the results of the surveillance activities referred to in Article 93(4);
        (b)   the final inspection report referred to in Article 93(7);
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 ---pagebreak---         (c)   information in relation to devices presenting an unacceptable risk to health and safety
              as referred to in Article 95(2), (4) and (6);
        (d)   information in relation to non-compliance of products as referred to in Article 97(2);
        (e)   information in relation to the preventive health protection measures referred to in
              Article 98(2);
        (f)   summaries of the results of the reviews and assessments of the market surveillance
              activities of the Member States referred to in 93(8).
2.      The information referred to in paragraph 1 of this Article shall be immediately transmitted
        through the electronic system to all competent authorities concerned and, where applicable,
        to the notified body that issued a certificate in accordance with Article 56 for the device
        concerned and be accessible to the Member States and to the Commission.
3.      Information exchanged between Member States shall not be made public where to do so
        might impair market surveillance activities and co-operation between Member States.
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 ---pagebreak---                                         Chapter VIII
                       Cooperation between Member States,
                       Medical Device Coordination Group,
             expert laboratories, expert panels and device registers
                                             Article 101
                                       Competent authorities
The Member States shall designate the competent authority or authorities responsible for the
implementation of this Regulation. They shall entrust their authorities with the powers, resources,
equipment and knowledge necessary for the proper performance of their tasks pursuant to this
Regulation. The Member States shall communicate the names and contact details of the competent
authorities to the Commission which shall publish a list of competent authorities.
                                             Article 102
                                            Cooperation
1.       The competent authorities of the Member States shall cooperate with each other and with
         the Commission. The Commission shall provide for the organisation of exchanges of
         information necessary to enable this Regulation to be applied uniformly.
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 ---pagebreak--- 2.      Member States shall with the support of the Commission participate, where appropriate, in
        initiatives developed at international level with the aim of ensuring cooperation between
        regulatory authorities in the field of medical devices.
                                              Article 103
                                Medical Device Coordination Group
1.      A Medical Device Coordination Group ('MDCG') is hereby established.
2.      Each Member State shall appoint to the MDCG, for a three-year term which may be
        renewed, one member and one alternate each with expertise in the field of medical devices,
        and one member and one alternate with expertise in the field of in vitro diagnostic medical
        devices. A Member State may choose to appoint only one member and one alternate, each
        with expertise in both fields.
        The members of the MDCG shall be chosen for their competence and experience in the
        field of medical devices and in vitro diagnostic medical devices. They shall represent the
        competent authorities of the Member States. The names and affiliation of members shall be
        made public by the Commission.
        The alternates shall represent and vote for the members in their absence.
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 ---pagebreak--- 3.      The MDCG shall meet at regular intervals and, where the situation requires, upon request
        by the Commission or a Member State. The meetings shall be attended either by the
        members appointed for their role and expertise in the field of medical devices, or by the
        members appointed for their expertise in the field of in vitro diagnostic medical devices, or
        by the members appointed for their expertise in both fields, or their alternates, as
        appropriate.
4.      The MDCG shall use its best endeavours to reach consensus. If such consensus cannot be
        reached, the MDCG shall decide by a majority of its members. Members with diverging
        positions may request that their positions and the grounds on which they are based are
        recorded in the MDCG's position.
5.      The MDCG shall be chaired by a representative of the Commission. The chair shall not
        take part in votes of the MDCG.
6.      The MDCG may invite, on a case-by-case basis, experts and other third parties to attend
        meetings or provide written contributions.
7.      The MDCG may establish standing or temporary sub-groups. Where appropriate,
        organisations representing the interests of the medical device industry, healthcare
        professionals, laboratories, patients and consumers at Union level shall be invited to such
        sub-groups in the capacity of observers.
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 ---pagebreak--- 8.       The MDCG shall establish its rules of procedure which shall, in particular, lay down
         procedures for the following:
         –       the adoption of opinions or recommendations or other positions, including in cases of
                 urgency;
         –       the delegation of tasks to reporting and co-reporting members;
         –       the implementation of Article 107 regarding conflict of interests;
         –       the functioning of sub-groups.
9.       The MDCG shall have the tasks laid down in Article 105 of this Regulation and Article 99
         of Regulation (EU) 2017/… +.
                                                 Article 104
                                         Support by the Commission
The Commission shall support the functioning of the cooperation between national competent
authorities. It shall, in particular, provide for the organisation of exchanges of experience between
the competent authorities and provide technical, scientific and logistic support to the MDCG and its
sub-groups. It shall organise the meetings of the MDCG and its sub-groups, participate in those
meetings and ensure the appropriate follow-up.
+
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 ---pagebreak---                                              Article 105
                                         Tasks of the MDCG
Under this Regulation, the MDCG shall have the following tasks:
(a)     to contribute to the assessment of applicant conformity assessment bodies and notified
        bodies pursuant to the provisions set out in Chapter IV;
(b)     to advise the Commission, at its request, in matters concerning the coordination group of
        notified bodies as established pursuant to Article 49;
(c)     to contribute to the development of guidance aimed at ensuring effective and harmonised
        implementation of this Regulation, in particular regarding the designation and monitoring
        of notified bodies, application of the general safety and performance requirements and
        conduct of clinical evaluations and investigations by manufacturers, assessment by notified
        bodies and vigilance activities;
(d)     to contribute to the continuous monitoring of technical progress and assessment of whether
        the general safety and performance requirements laid down in this Regulation and
        Regulation (EU) 2017/… + are adequate to ensure safety and performance of devices, and
        thereby contribute to identifying whether there is a need to amend Annex I to this
        Regulation;
+
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 ---pagebreak--- (e)     to contribute to the development of device standards, of CS and of scientific guidelines,
        including product specific guidelines, on clinical investigation of certain devices in
        particular implantable devices and class III devices;
(f)     to assist the competent authorities of the Member States in their coordination activities in
        particular in the fields of classification and the determination of the regulatory status of
        devices, clinical investigations, vigilance and market surveillance including the
        development and maintenance of a framework for a European market surveillance program
        with the objective of achieving efficiency and harmonisation of market surveillance in the
        Union, in accordance with Article 93;
(g)     to provide advice, either on its own initiative or at request of the Commission, in the
        assessment of any issue related to the implementation of this Regulation;
(h)     to contribute to harmonised administrative practice with regard to devices in the
        Member States.
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 ---pagebreak---                                                Article 106
                 Provision of scientific, technical and clinical opinions and advice
1.      The Commission shall, by means of implementing acts and in consultation with the
        MDCG, make provision for expert panels to be designated for the assessment of the
        clinical evaluation in relevant medical fields as referred to in paragraph 9 of this
        Article and to provide views in accordance with Article 48(6) of Regulation (EU) 2017/… +
        on the performance evaluation of certain in vitro diagnostic medical devices and, where
        necessary, for categories or groups of devices, or for specific hazards relating to categories
        or groups of devices, observing the principles of highest scientific competence,
        impartiality, independence and transparency. The same principles shall apply where the
        Commission decides to appoint expert laboratories in accordance with paragraph 7 of this
        Article.
2.      Expert panels and expert laboratories may be designated in areas where the Commission,
        in consultation with the MDCG, has identified a need for the provision of consistent
        scientific, technical and/or clinical advice or laboratory expertise in relation to the
        implementation of this Regulation. Expert panels and expert laboratories may be appointed
        on a standing or temporary basis.
+
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 ---pagebreak--- 3.      Expert panels shall consist of advisors appointed by the Commission on the basis of
        up-to-date clinical, scientific or technical expertise in the field and with a geographical
        distribution that reflects the diversity of scientific and clinical approaches in the Union.
        The Commission shall determine the number of members of each panel in accordance with
        the requisite needs.
        The members of expert panels shall perform their tasks with impartiality and objectivity.
        They shall neither seek nor take instructions from notified bodies or manufacturers. Each
        member shall draw up a declaration of interests which shall be made publicly available.
        The Commission shall establish systems and procedures to actively manage and prevent
        potential conflicts of interest.
4.      Expert panels shall take into account relevant information provided by stakeholders
        including patients' organisations and healthcare professionals when preparing their
        scientific opinions.
5.      The Commission, following consultation with the MDCG, may appoint advisors to expert
        panels following publication in the Official Journal of the European Union and on the
        Commission website following a call for expressions of interest. Depending on the type of
        task and the need for specific expertise, advisors may be appointed to the expert panels for
        a maximum period of three years and their appointment may be renewed.
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 ---pagebreak--- 6.      The Commission, following consultation with the MDCG, may include advisors on a
        central list of available experts who, whilst not being formally appointed to a panel, are
        available to provide advice and to support the work of the expert panel as needed. That list
        shall be published on the Commission website.
7.      The Commission may, by means of implementing acts and following consultation with the
        MDCG, designate expert laboratories, on the basis of their expertise in:
        –     physico-chemical characterisation, or
        –     microbiological, biocompatibility, mechanical, electrical, electronic or non-clinical
              biological and toxicological testing
        of specific devices, categories or groups of devices.
        The Commission shall only designate expert laboratories for which a Member State or the
        Joint Research Centre has submitted an application for designation.
8.      Expert laboratories shall satisfy the following criteria:
        (a)   have adequate and appropriately qualified staff with adequate knowledge and
              experience in the field of the devices for which they are designated;
        (b)   possess the necessary equipment to carry out the tasks assigned to them;
        (c)   have the necessary knowledge of international standards and best practices;
        (d)   have an appropriate administrative organisation and structure;
        (e)   ensure that their staff observe the confidentiality of information and data obtained in
              carrying out their tasks.
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 ---pagebreak--- 9.      Expert panels appointed for clinical evaluation in relevant medical fields shall fulfil the
        tasks provided for in Article 54(1) and Article 61(2) and Section 5.1 of Annex IX or
        Section 6 of Annex X, as applicable.
10.     Expert panels and expert laboratories may have the following tasks, depending on the
        requisite needs:
        (a)   to provide scientific, technical and clinical assistance to the Commission and the
              MDCG in relation to the implementation of this Regulation;
        (b)   to contribute to the development and maintenance of appropriate guidance and CS
              for:
              –     clinical investigations,
              –     clinical evaluation and PMCF,
              –     performance studies,
              –     performance evaluation and post-market performance follow-up,
              –     physico-chemical characterisation, and
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 ---pagebreak---              –     microbiological, biocompatibility, mechanical, electrical, electronic or
                   non-clinical toxicological testing
             for specific devices, or a category or group of devices, or for specific hazards related
             to a category or group of devices;
        (c)  to develop and review clinical evaluation guidance and performance evaluation
             guidance for performance of conformity assessment in line with the state of the art
             with regard to clinical evaluation, performance evaluation, physico-chemical
             characterisation, and microbiological, biocompatibility, mechanical, electrical,
             electronic or non-clinical toxicological testing;
        (d)  to contribute to the development of standards at international level, ensuring that
             such standards reflect the state of the art;
        (e)  to provide opinions in response to consultations by manufacturers in accordance with
             Article 61(2), notified bodies and Member States in accordance with paragraphs 11
             to 13 of this Article.
        (f)  to contribute to identification of concerns and emerging issues on the safety and
             performance of medical devices;
        (g)  to provide views in accordance with Article 48(4) of Regulation (EU) 2017/… + on
             the performance evaluation of certain in vitro diagnostic medical devices.
+
      OJ: Please insert the serial number of the Regulation in st10729/16.
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                                              DGB 2C                                             EN
 ---pagebreak--- 11.     The Commission, shall facilitate the access of Member States and notified bodies and
        manufacturers to advice provided by expert panels and expert laboratories concerning,
        inter alia, the criteria for an appropriate data set for assessment of the conformity of a
        device, in particular with regard to the clinical data required for clinical evaluation, with
        regard to physico-chemical characterisation, and with regard to microbiological,
        biocompatibility, mechanical, electrical, electronic and non-clinical toxicological testing.
12.     When adopting its scientific opinion in accordance with paragraph 9, the members of the
        expert panels shall use their best endeavours to reach consensus. If consensus cannot be
        reached, the expert panels shall decide by a majority of their members, and the scientific
        opinion shall mention the divergent positions and the grounds on which they are based.
        The Commission shall publish the scientific opinion and advice delivered in accordance
        with paragraphs 9 and 11 of this Article, ensuring consideration of aspects of
        confidentiality as set out in Article 109. The clinical evaluation guidance referred to in
        point (c) of paragraph 10 shall be published following consultation with the MDCG.
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 ---pagebreak--- 13.     The Commission may require manufacturers and notified bodies to pay fees for the advice
        provided by expert panels and expert laboratories. The structure and the level of fees as
        well as the scale and structure of recoverable costs shall be adopted by the Commission by
        means of implementing acts, taking into account the objectives of the adequate
        implementation of this Regulation, protection of health and safety, support of innovation
        and cost-effectiveness and the necessity to achieve active participation in the expert panels.
        Those implementing acts shall be adopted in accordance with the examination procedure
        referred to in Article 114(3).
14.     The fees payable to the Commission in accordance with the procedure under paragraph 13
        of this Article shall be set in a transparent manner and on the basis of the costs for the
        services provided. The fees payable shall be reduced in the case of a clinical evaluation
        consultation procedure initiated in accordance with point (c) of Section 5.1 of Annex IX
        involving a manufacturer who is a micro, small or medium-sized enterprise within the
        meaning of Recommendation 2003/361/EC.
15.     The Commission is empowered to adopt delegated acts in accordance with Article 115 to
        amend the tasks of expert panels and expert laboratories referred to in paragraph 10 of this
        Article.
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 ---pagebreak---                                                Article 107
                                           Conflict of interests
1.       Members of the MDCG, its sub-groups, and members of expert panels and expert
         laboratories shall not have financial or other interests in the medical device industry which
         could affect their impartiality. They shall undertake to act in the public interest and in an
         independent manner. They shall declare any direct or indirect interests they may have in
         the medical device industry and update that declaration whenever a relevant change occurs.
         The declaration of interests shall be made publicly available on the Commission website.
         This Article shall not apply to the representatives of stakeholder organisations participating
         in the sub-groups of the MDCG.
2.       Experts and other third parties invited by the MDCG on a case-by-case basis shall declare
         any interests they may have in the issue in question.
                                               Article 108
                                    Device registers and data banks
The Commission and the Member States shall take all appropriate measures to encourage the
establishment of registers and data banks for specific types of devices setting common principles to
collect comparable information. Such registers and data banks shall contribute to the independent
evaluation of the long-term safety and performance of devices, or the traceability of implantable
devices, or all of such characteristics.
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                                                DGB 2C                                              EN
 ---pagebreak---                                           Chapter IX
           Confidentiality, data protection, funding and penalties
                                             Article 109
                                           Confidentiality
1.      Unless otherwise provided for in this Regulation and without prejudice to existing national
        provisions and practices in the Member States on confidentiality, all parties involved in the
        application of this Regulation shall respect the confidentiality of information and data
        obtained in carrying out their tasks in order to protect the following:
        (a)   personal data, in accordance with Article 110;
        (b)   commercially confidential information and trade secrets of a natural or legal person,
              including intellectual property rights; unless disclosure is in the public interest;
        (c)   the effective implementation of this Regulation, in particular for the purpose of
              inspections, investigations or audits.
2.      Without prejudice to paragraph 1, information exchanged on a confidential basis between
        competent authorities and between competent authorities and the Commission shall not be
        disclosed without the prior agreement of the originating authority.
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                                               DGB 2C                                              EN
 ---pagebreak--- 3.      Paragraphs 1 and 2 shall not affect the rights and obligations of the Commission,
        Member States and notified bodies with regard to exchange of information and the
        dissemination of warnings, nor the obligations of the persons concerned to provide
        information under criminal law.
4.      The Commission and Member States may exchange confidential information with
        regulatory authorities of third countries with which they have concluded bilateral or
        multilateral confidentiality arrangements.
                                             Article 110
                                           Data protection
1.      Member States shall apply Directive 95/46/EC to the processing of personal data carried
        out in the Member States pursuant to this Regulation.
2.      Regulation (EC) No 45/2001 shall apply to the processing of personal data carried out by
        the Commission pursuant to this Regulation.
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 ---pagebreak---                                                 Article 111
                                              Levying of fees
1.       This Regulation shall be without prejudice to the possibility for Member States to levy fees
         for the activities set out in this Regulation, provided that the level of the fees is set in a
         transparent manner and on the basis of cost-recovery principles.
2.       Member States shall inform the Commission and the other Member States at least three
         months before the structure and level of fees is to be adopted. The structure and level of
         fees shall be made publicly available on request.
                                                Article 112
                               Funding of activities related to designation
                                     and monitoring of notified bodies
The costs associated with joint assessment activities shall be covered by the Commission. The
Commission shall, by means of implementing acts, lay down the scale and structure of recoverable
costs and other necessary implementing rules. Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 114(3).
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 ---pagebreak---                                                Article 113
                                                Penalties
The Member States shall lay down the rules on penalties applicable for infringement of the
provisions of this Regulation and shall take all measures necessary to ensure that they are
implemented. The penalties provided for shall be effective, proportionate, and dissuasive. The
Member States shall notify the Commission of those rules and of those measures by … [3 months
prior to the date of application of this Regulation] and shall notify it without delay of any
subsequent amendment affecting them.
                                             Chapter X
                                          Final provisions
                                               Article 114
                                          Committee procedure
1.        The Commission shall be assisted by a Committee on Medical Devices. That Committee
          shall be a committee within the meaning of Regulation (EU) No 182/2011.
2.        Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall
          apply.
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 ---pagebreak--- 3.      Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall
        apply.
        Where the committee delivers no opinion, the Commission shall not adopt the draft
        implementing act and the third subparagraph of Article 5(4) of
        Regulation (EU) No 182/2011 shall apply.
4.      Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in
        conjunction with Article 4 or Article 5 thereof, as appropriate, shall apply.
                                             Article 115
                                     Exercise of the delegation
1.      The power to adopt delegated acts is conferred on the Commission subject to the
        conditions laid down in this Article.
2.      The power to adopt delegated acts referred to in Articles 1(5), 3, 10(4), 18(3), 19(4),
        27(10), 44(11), 52(5), 56(6), 61(8), 70(8) and 106(15) shall be conferred on the
        Commission for a period of five years from … [date of entry into force of this Regulation].
        The Commission shall draw up a report in respect of the delegation of power not later than
        nine months before the end of the five year period. The delegation of power shall be tacitly
        extended for periods of an identical duration, unless the European Parliament or the
        Council opposes such extension not later than three months before the end of each period.
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 ---pagebreak--- 3.      The delegation of power referred to in Articles 1(5), 3, 10(4), 18(3), 19(4), 27(10), 44(11),
        52(5), 56(6), 61(8), 70(8) and 106(15) may be revoked at any time by the European
        Parliament or by the Council. A decision to revoke shall put an end to the delegation of the
        power specified in that decision. It shall take effect the day following the publication of the
        decision in the Official Journal of the European Union or at a later date specified therein.
        It shall not affect the validity of any delegated acts already in force.
4.      Before adopting a delegated act, the Commission shall consult experts designated by each
        Member State in accordance with the principles laid down in the Interinstitutional
        Agreement of 13 April 2016 on Better Law-Making.
5.      As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the
        European Parliament and to the Council.
6.      A delegated act adopted pursuant to Articles 1(5), 3, 10(4), 18(3), 19(4), 27(10), 44(11),
        52(5), 56(6), 61(8), 70(8) and 106(15) shall enter into force only if no objection has been
        expressed either by the European Parliament or by the Council within a period of three
        months of notification of that act to the European Parliament and the Council or if, before
        the expiry of that period, the European Parliament and the Council have both informed the
        Commission that they will not object. That period shall be extended by three months at the
        initiative of the European Parliament or of the Council.
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                                                 DGB 2C                                           EN
 ---pagebreak---                                               Article 116
                       Separate delegated acts for different delegated powers
The Commission shall adopt a separate delegated act in respect of each power delegated to it
pursuant to this Regulation.
                                              Article 117
                                 Amendment to Directive 2001/83/EC
In Annex I to Directive 2001/83/EC, point 12 of Section 3.2. is replaced by the following:
'(12)   Where, in accordance with the second subparagraph of Article 1(8) or the second
        subparagraph of Article 1(9) of Regulation (EU) 2017/… of the European Parliament and
        of the Council∗+, a product is governed by this Directive, the marketing authorisation
        dossier shall include, where available, the results of the assessment of the conformity of the
        device part with the relevant general safety and performance requirements set out in
        Annex I to that Regulation contained in the manufacturer's EU declaration of conformity or
        the relevant certificate issued by a notified body allowing the manufacturer to affix a
        CE marking to the medical device.
+
       OJ: Please insert the serial number of the Regulation in st10728/16.
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                                               DGB 2C                                           EN
 ---pagebreak---         If the dossier does not include the results of the conformity assessment referred to in the
        first subparagraph and where for the conformity assessment of the device, if used
        separately, the involvement of a notified body is required in accordance with
        Regulation (EU) 2017… +, the authority shall require the applicant to provide an opinion on
        the conformity of the device part with the relevant general safety and performance
        requirements set out in Annex I to that Regulation issued by a notified body designated in
        accordance with that Regulation for the type of device in question.
        ___________________
        *
               Regulation (EU) 2017/… of the European Parliament and of the Council of … on
               medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and
               Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and
               93/42/EEC (OJ L …, …, p. …). ++'.
+
      OJ: Please insert the serial number of the Regulation in st10728/16.
++
      OJ: Please insert the publication details for the Regulation in st10728/16.
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 ---pagebreak---                                                 Article 118
                              Amendment to Regulation (EC) No 178/2002
In the third subparagraph of Article 2 of Regulation (EC) No 178/2002, the following point is
added:
'(i)      medical devices within the meaning of Regulation (EU) 2017/… of the European
          Parliament and of the Council*+.
          __________________
          *
                 Regulation (EU) 2017/… of the European Parliament and of the Council of … on
                 medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and
                 Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and
                 93/42/EEC (OJ L …, …, p. …). ++'.
                                                Article 119
                             Amendment to Regulation (EC) No 1223/2009
In Article 2 of Regulation (EC) No 1223/2009, the following paragraph is added:
'4.       The Commission may, at the request of a Member State or on its own initiative, adopt the
          necessary measures to determine whether or not a specific product or group of products
          falls within the definition 'cosmetic product'. Those measures shall be adopted in
          accordance with the regulatory procedure referred to in Article 32(2).'.
+
        OJ: Please insert the number for the Regulation in st10728/16.
++
        OJ: Please insert the publication details for the Regulation in st10728/16.
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 ---pagebreak---                                              Article 120
                                       Transitional provisions
1.      From … [date of application of this Regulation], any publication of a notification in
        respect of a notified body in accordance with Directives 90/385/EEC and 93/42/EEC shall
        become void.
2.      Certificates issued by notified bodies in accordance with Directives 90/385/EEC and
        93/42/EEC prior to … [date of the entry into force of this Regulation] shall remain valid
        until the end of the period indicated on the certificate, except for certificates issued in
        accordance with Annex 4 to Directive 90/385/EEC or Annex IV to Directive 93/42/EEC
        which shall become void at the latest on … [two years after the date of application of this
        Regulation].
        Certificates issued by notified bodies in accordance with Directives 90/385/EEC and
        93/42/EEC from … [date of entry into force of this Regulation] shall remain valid until the
        end of the period indicated on the certificate, which shall not exceed five years from its
        issuance. They shall however become void at the latest on … [four years after the date of
        application of this Regulation].
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 ---pagebreak--- 3.      By way of derogation from Article 5 of this Regulation, a device with a certificate that was
        issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and which is
        valid by virtue of paragraph 2 of this Article may only be placed on the market or put into
        service provided that from the date of application of this Regulation it continues to comply
        with either of those Directives, and provided there are no significant changes in the design
        and intended purpose. However, the requirements of this Regulation relating to
        post-market surveillance, market surveillance, vigilance, registration of economic
        operators and of devices shall apply in place of the corresponding requirements in
        those Directives.
        Without prejudice to Chapter IV and paragraph 1 of this Article, the notified body that
        issued the certificate referred to in the first subparagraph shall continue to be responsible
        for the appropriate surveillance in respect of all of the applicable requirements relating to
        the devices it has certified.
4.      Devices lawfully placed on the market pursuant to Directives 90/385/EEC and 93/42/EEC
        prior to … [date of application of this Regulation], and devices placed on the market from
        … [date of application of this Regulation] by virtue of a certificate as referred to in
        paragraph 2 of this Article, may continue to be made available on the market or put into
        service until … [five years after the date of application of this Regulation].
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 ---pagebreak--- 5.      By way of derogation from Directives 90/385/EEC and 93/42/EEC, devices which comply
        with this Regulation may be placed on the market prior to … [date of application of this
        Regulation].
6.      By way of derogation from Directives 90/385/EEC and 93/42/EEC, conformity assessment
        bodies which comply with this Regulation may be designated and notified prior to … [date
        of application of this Regulation]. Notified bodies which are designated and notified in
        accordance with this Regulation may carry out the conformity assessment procedures laid
        down in this Regulation and issue certificates in accordance with this Regulation prior to
        … [date of application of this Regulation].
7.      As regards devices subject to the consultation procedure laid down in Article 54,
        paragraph 5 of this Article shall apply provided that the necessary appointments to the
        MDCG and expert panels have been made.
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                                               DGB 2C                                           EN
 ---pagebreak--- 8.      By way of derogation from Article 10a and point (a) of Article 10b(1) of
        Directive 90/385/EEC and Article 14(1) and (2) and points (a) and (b) of Article 14a(1) of
        Directive 93/42/EEC, manufacturers, authorised representatives, importers and notified
        bodies which, during the period starting on the later of the dates referred to point (d) of
        Article 123(3) and ending 18 months later, comply with Article 29(4) and Article 56(5) of
        this Regulation shall be considered to comply with the laws and regulations adopted by
        Member States in accordance with, respectively, Article 10a of Directive 90/385/EEC or
        Article 14(1) and (2) of Directive 93/42/EEC and with, respectively, point (a) of
        Article 10b(1) of Directive 90/385/EEC or points (a) and (b) of Article 14a(1) of
        Directive 93/42/EEC as specified in Decision 2010/227/EU.
9.      Authorisations granted by the competent authorities of the Member States in accordance
        with Article 9(9) of Directive 90/385/EEC or Article 11(13) of Directive 93/42/EEC shall
        keep the validity indicated in the authorisation.
10.     Devices falling within the scope of this Regulation in accordance with points (f) and (g) of
        Article 1(6) which have been legally placed on the market or put into service in accordance
        with the rules in force in the Member States prior to … [date of application of this
        Regulation] may continue to be placed on the market and put into service in the
        Member States concerned.
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 ---pagebreak--- 11.      Clinical investigations which have started to be conducted in accordance with Article 10 of
         Directive 90/385/EEC or Article 15 of Directive 93/42/EEC prior to … [date of application
         of this Regulation] may continue to be conducted. As of … [date of application of this
         Regulation], however, the reporting of serious adverse events and device deficiencies shall
         be carried out in accordance with this Regulation.
12.      Until the Commission has designated, pursuant to Article 27(2), issuing entities, GS1,
         HIBCC and ICCBBA shall be considered to be designated issuing entities.
                                              Article 121
                                              Evaluation
By … [seven years after the date of application of this Regulation], the Commission shall assess the
application of this Regulation and produce an evaluation report on the progress towards
achievement of the objectives contained herein including an assessment of the resources required to
implement this Regulation. Special attention shall be given to the traceability of medical devices
through the storage, pursuant to Article 27, of the UDI by economic operators, health institutions
and health professionals.
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 ---pagebreak---                                                 Article 122
                                                   Repeal
Without prejudice to Articles 120(3) and (4) of this Regulation, and without prejudice to the
obligations of the Member States and manufacturers as regards vigilance and to the obligations of
manufacturers as regards the making available of documentation, under Directives 90/385/EEC and
93/42/EEC, those Directives are repealed with effect from … [date of application of this
Regulation], with the exception of:
–        Articles 8 and 10, points (b) and (c) of Article 10b(1), Article 10b(2) and Article 10b(3) of
         Directive 90/385/EEC, and the obligations relating to vigilance and clinical investigations
         provided for in the corresponding Annexes, which are repealed with effect from the later of
         the dates referred to in point (d) of Article 123(3) of this Regulation;
–        Article 10a and point (a) of Article 10b(1) of Directive 90/385/EEC, and the obligations
         relating to registration of devices and economic operators, and to certificate notifications,
         provided for in the corresponding Annexes, which are repealed with effect from 18 months
         after the later of the dates referred to in point (d) of Article 123(3) of this Regulation;
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 ---pagebreak--- –        Article 10, points (c) and (d) of Article 14a(1), Article 14a(2), Article 14a(3) and
         Article 15 of Directive 93/42/EEC, and the obligations relating to vigilance and clinical
         investigations provided for in the corresponding Annexes, which are repealed with effect
         from the later of the dates referred to in point (d) of Article 123(3) of this Regulation; and
–        Article 14(1) and (2) and points (a) and (b) of Article 14a(1) of Directive 93/42/EEC, and
         the obligations relating to registration of devices and economic operators, and to certificate
         notifications, provided for in the corresponding Annexes, which are repealed with effect
         from 18 months after the later of the dates referred to in point (d) of Article 123(3) of this
         Regulation.
As regards the devices referred to in Article 120 (3) and (4) of this Regulation, the Directives
referred to in the first paragraph shall continue to apply until … [five years after the date of
application of this Regulation] to the extent necessary for the application of those paragraphs.
Notwithstanding the first paragraph, Regulations (EU) No 207/2012 and (EU) No 722/2012 shall
remain in force and continue to apply unless and until repealed by implementing acts adopted by the
Commission pursuant to this Regulation.
References to the repealed Directives shall be understood as references to this Regulation and shall
be read in accordance with the correlation table laid down in Annex XVII to this Regulation.
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 ---pagebreak---                                               Article 123
                               Entry into force and date of application
1.      This Regulation shall enter into force on the twentieth day following that of its publication
        in the Official Journal of the European Union.
2.      It shall apply from … [three years after the date of entry into force of this Regulation].
3.      By way of derogation from paragraph 2:
        (a)    Articles 35 to 50 shall apply from … [six months after the date of entry into force of
               this Regulation]. However, from that date until … [date of application of this
               Regulation], the obligations on notified bodies pursuant to Articles 35 to 50 shall
               apply only to those bodies which submit an application for designation in accordance
               with Article 38;
        (b)    Articles 101 and 103 shall apply from … [six months after the date of entry into
               force of this Regulation];
        (c)    Article 102 shall apply from … [twelve months after the date of entry into force of
               this Regulation];
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 ---pagebreak---         (d) without prejudice to the obligations on the Commission pursuant to Article 34,
            where, due to circumstances that could not reasonably have been foreseen when
            drafting the plan referred to in Article 34(1), Eudamed is not fully functional on …
            [three years after the date of entry into force of this Regulation], the obligations and
            requirements that relate to Eudamed shall apply from the date corresponding to
            six months after the date of publication of the notice referred to in Article 34(3). The
            provisions referred to in the preceding sentence are:
            –     Article 29,
            –     Article 31,
            –     Article 32,
            –     Article 33(4),
            –     the second sentence of Article 40(2),
            –     Article 42(10),
            –     Article 43(2),
            –     the second subparagraph of Article 44(12),
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                                              DGB 2C                                             EN
 ---pagebreak---          – points (d) and (e) of Article 46(7),
         – Article 53(2),
         – Article 54(3),
         – Article 55(1),
         – Articles 70 to 77,
         – paragraphs 1 to 13 of Article 78,
         – Articles 79 to 82,
         – Article 86(2),
         – Articles 87 and 88,
         – Article 89(5) and (7), and the third subparagraph of Article 89(8),
         – Article 90,
         – Article 93(4), (7) and (8),
         – Article 95(2) and (4),
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                                       DGB 2C                                  EN
 ---pagebreak---             –     the last sentence of Article 97(2),
            –     Article 99(4),
            –     the second sentence of the first subparagraph of Article 120(3).
            Until Eudamed is fully functional, the corresponding provisions of
            Directives 90/385/EEC and 93/42/EEC shall continue to apply for the purpose of
            meeting the obligations laid down in the provisions listed in the first paragraph of
            this point regarding exchange of information including, and in particular, information
            regarding vigilance reporting, clinical investigations, registration of devices and
            economic operators, and certificate notifications.
        (e) Article 29(4) and Article 56(5) shall apply from 18 months after the later of the dates
            referred to in point (d);
        (f) for implantable devices and for class III devices Article 27(4) shall apply from
            … [four years after the date of entry into force of this Regulation]. For class IIa and
            class IIb devices Article 27(4) shall apply from … [six years after the date of entry
            into force of this Regulation]. For class I devices Article 27(4) shall apply from
            … [eight years after the date of entry into force of this Regulation];
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 ---pagebreak---          (g)  for reusable devices that shall bear the UDI carrier on the device itself,
              Article 27(4) shall apply from two years after the date referred to in point (f) of
              this paragraph for the respective class of devices in that point;
         (h)  The procedure set out in Article 78 shall apply from … [ten years after the date
              of entry into force of this Regulation], without prejudice to Article 78(14);
         (i)  Article 120(12) shall apply from … [2 years after the date of entry into force of
              this Regulation].
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at …,
For the European Parliament                                  For the Council
The President                                                The President
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 ---pagebreak---                                            ANNEXES
I       General safety and performance requirements
II      Technical documentation
III     Technical documentation on post-market surveillance
IV      EU Declaration of conformity
V       CE marking of conformity
VI      Information to be submitted upon the registration of devices and economic operators in
        accordance with Articles 29(4) and 31; core data elements to be provided to the
        UDI database together with the UDI-DI in accordance with Articles 28 and 29;and the
        UDI system
VII     Requirements to be met by notified bodies
VIII    Classification rules
IX      Conformity assessment based on a quality management system and assessment of the
        technical documentation
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                                            DGB 2C                                           EN
 ---pagebreak--- X       Conformity assessment based on type examination
XI      Conformity assessment based on product conformity verification
XII     Certificates issued by a notified body
XIII    Procedure for custom-made devices
XIV     Clinical evaluation and post-market clinical follow-up
XV      Clinical investigations
XVI     List of groups of products without an intended medical purpose referred to in Article 1(2)
XVII    Correlation table
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 ---pagebreak---                                               ANNEX I
                 GENERAL SAFETY AND PERFORMANCE REQUIREMENTS
                                            Chapter I
                                   General requirements
1.      Devices shall achieve the performance intended by their manufacturer and shall be
        designed and manufactured in such a way that, during normal conditions of use, they are
        suitable for their intended purpose. They shall be safe and effective and shall not
        compromise the clinical condition or the safety of patients, or the safety and health of users
        or, where applicable, other persons, provided that any risks which may be associated with
        their use constitute acceptable risks when weighed against the benefits to the patient and
        are compatible with a high level of protection of health and safety, taking into account the
        generally acknowledged state of the art.
2.      The requirement in this Annex to reduce risks as far as possible means the reduction of
        risks as far as possible without adversely affecting the benefit-risk ratio.
3.      Manufacturers shall establish, implement, document and maintain a risk management
        system.
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ANNEX I                                        DGB 2C                                            EN
 ---pagebreak---         Risk management shall be understood as a continuous iterative process throughout the
        entire lifecycle of a device, requiring regular systematic updating. In carrying out risk
        management manufacturers shall:
        (a)   establish and document a risk management plan for each device;
        (b)   identify and analyse the known and foreseeable hazards associated with each device;
        (c)   estimate and evaluate the risks associated with, and occurring during, the intended
              use and during reasonably foreseeable misuse;
        (d)   eliminate or control the risks referred to in point (c) in accordance with the
              requirements of Section 4;
        (e)   evaluate the impact of information from the production phase and, in particular, from
              the post-market surveillance system, on hazards and the frequency of occurrence
              thereof, on estimates of their associated risks, as well as on the overall risk, benefit-
              risk ratio and risk acceptability; and
        (f)   based on the evaluation of the impact of the information referred to in point (e), if
              necessary amend control measures in line with the requirements of Section 4.
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ANNEX I                                         DGB 2C                                             EN
 ---pagebreak--- 4.      Risk control measures adopted by manufacturers for the design and manufacture of the
        devices shall conform to safety principles, taking account of the generally acknowledged
        state of the art. To reduce risks, Manufacturers shall manage risks so that the residual risk
        associated with each hazard as well as the overall residual risk is judged acceptable. In
        selecting the most appropriate solutions, manufacturers shall, in the following order of
        priority:
        (a)    eliminate or reduce risks as far as possible through safe design and manufacture;
        (b)    where appropriate, take adequate protection measures, including alarms if necessary,
               in relation to risks that cannot be eliminated; and
        (c)    provide information for safety (warnings/precautions/contra-indications) and, where
               appropriate, training to users.
        Manufacturers shall inform users of any residual risks.
5.      In eliminating or reducing risks related to use error, the manufacturer shall:
        (a)    reduce as far as possible the risks related to the ergonomic features of the device and
               the environment in which the device is intended to be used (design for patient
               safety), and
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ANNEX I                                          DGB 2C                                           EN
 ---pagebreak---         (b)   give consideration to the technical knowledge, experience, education, training and
              use environment, where applicable, and the medical and physical conditions of
              intended users (design for lay, professional, disabled or other users).
6.      The characteristics and performance of a device shall not be adversely affected to such a
        degree that the health or safety of the patient or the user and, where applicable, of other
        persons are compromised during the lifetime of the device, as indicated by the
        manufacturer, when the device is subjected to the stresses which can occur during normal
        conditions of use and has been properly maintained in accordance with the manufacturer's
        instructions.
7.      Devices shall be designed, manufactured and packaged in such a way that their
        characteristics and performance during their intended use are not adversely affected during
        transport and storage, for example, through fluctuations of temperature and humidity,
        taking account of the instructions and information provided by the manufacturer.
8.      All known and foreseeable risks, and any undesirable side-effects, shall be minimised and
        be acceptable when weighed against the evaluated benefits to the patient and/or user
        arising from the achieved performance of the device during normal conditions of use.
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ANNEX I                                        DGB 2C                                             EN
 ---pagebreak--- 9.      For the devices referred to in Annex XVI, the general safety requirements set out in
        Sections 1 and 8 shall be understood to mean that the device, when used under the
        conditions and for the purposes intended, does not present a risk at all or presents a risk
        that is no more than the maximum acceptable risk related to the product's use which is
        consistent with a high level of protection for the safety and health of persons.
                                            Chapter II
               Requirements regarding design and manufacture
10.     Chemical, physical and biological properties
10.1.   Devices shall be designed and manufactured in such a way as to ensure that the
        characteristics and performance requirements referred to in Chapter I are fulfilled.
        Particular attention shall be paid to:
        (a)    the choice of materials and substances used, particularly as regards toxicity and,
               where relevant, flammability;
        (b)    the compatibility between the materials and substances used and biological tissues,
               cells and body fluids, taking account of the intended purpose of the device and,
               where relevant, absorption, distribution, metabolism and excretion;
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ANNEX I                                        DGB 2C                                             EN
 ---pagebreak---         (c)   the compatibility between the different parts of a device which consists of more than
              one implantable part;
        (d)   the impact of processes on material properties;
        (e)   where appropriate, the results of biophysical or modelling research the validity of
              which has been demonstrated beforehand;
        (f)   the mechanical properties of the materials used, reflecting, where appropriate,
              matters such as strength, ductility, fracture resistance, wear resistance and fatigue
              resistance;
        (g)   surface properties; and
        (h)   the confirmation that the device meets any defined chemical and/or physical
              specifications.
10.2.   Devices shall be designed, manufactured and packaged in such a way as to minimise the
        risk posed by contaminants and residues to patients, taking account of the intended purpose
        of the device, and to the persons involved in the transport, storage and use of the devices.
        Particular attention shall be paid to tissues exposed to those contaminants and residues and
        to the duration and frequency of exposure.
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ANNEX I                                         DGB 2C                                            EN
 ---pagebreak--- 10.3.   Devices shall be designed and manufactured in such a way that they can be used safely
        with the materials and substances, including gases, with which they enter into contact
        during their intended use; if the devices are intended to administer medicinal products they
        shall be designed and manufactured in such a way as to be compatible with the medicinal
        products concerned in accordance with the provisions and restrictions governing those
        medicinal products and that the performance of both the medicinal products and of the
        devices is maintained in accordance with their respective indications and intended use.
10.4.   Substances
10.4.1. Design and manufacture of devices
        Devices shall be designed and manufactured in such a way as to reduce as far as possible
        the risks posed by substances or particles, including wear debris, degradation products and
        processing residues, that may be released from the device.
        Devices, or those parts thereof or those materials used therein that:
        –      are invasive and come into direct contact with the human body,
        –      (re)administer medicines, body liquids or other substances, including gases, to/from
               the body, or
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ANNEX I                                        DGB 2C                                            EN
 ---pagebreak---         –     transport or store such medicines, body fluids or substances, including gases, to be
              (re)administered to the body,
        shall only contain the following substances in a concentration that is above 0,1 % weight
        by weight (w/w) where justified pursuant to Section 10.4.2:
        (a)   substances which are carcinogenic, mutagenic or toxic to reproduction ('CMR'), of
              category 1A or 1B, in accordance with Part 3 of Annex VI to Regulation
              (EC) No 1272/2008 of the European Parliament and of the Council 1, or
        (b)   substances having endocrine-disrupting properties for which there is scientific
              evidence of probable serious effects to human health and which are identified either
              in accordance with the procedure set out in Article 59 of
              Regulation (EC) No 1907/2006 of the European Parliament and of the Council 2 or,
              once a delegated act has been adopted by the Commission pursuant to the first
              subparagraph of Article 5(3) of Regulation (EU) No 528/2012 of the European
              Parliament and the Council 3, in accordance with the criteria that are relevant to
              human health amongst the criteria established therein.
1
      Regulation (EC) No 1272/2008 of the European Parliament and of the Council of
      16 December 2008 on classification, labelling and packaging of substances and mixtures,
      amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending
      Regulation (EC) No 1907/2006 ( OJ L 353, 31.12.2008, p. 1).
2
      Regulation (EC) No 1907/2006 of the European Parliament and of the Council of
      18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of
      Chemicals (REACH) (OJ L 396, 30.12.2006, p. 1).
3
      Regulation (EU) No 528/2012 of the European Parliament and the Council of 22 May 2012
      concerning the making available on the market of and use of biocidal products (OJ L 167,
      27.06.2012, p. 1).
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ANNEX I                                       DGB 2C                                             EN
 ---pagebreak--- 10.4.2. Justification regarding the presence of CMR and/or endocrine-disrupting substances
        The justification for the presence of such substances shall be based upon:
        (a)    an analysis and estimation of potential patient or user exposure to the substance;
        (b)    an analysis of possible alternative substances, materials or designs, including, where
               available, information about independent research, peer-reviewed studies, scientific
               opinions from relevant scientific committees and an analysis of the availability of
               such alternatives;
        (c)    argumentation as to why possible substance and/ or material substitutes, if available,
               or design changes, if feasible, are inappropriate in relation to maintaining the
               functionality, performance and the benefit-risk ratios of the product; including taking
               into account if the intended use of such devices includes treatment of children or
               treatment of pregnant or breastfeeding women or treatment of other patient groups
               considered particularly vulnerable to such substances and/or materials; and
        (d)    where applicable and available, the latest relevant scientific committee guidelines in
               accordance with Sections 10.4.3. and 10.4.4.
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ANNEX I                                         DGB 2C                                            EN
 ---pagebreak--- 10.4.3. Guidelines on phthalates
        For the purposes of Section 10.4., the Commission shall, as soon as possible and by …
        [one year after the date of entry into force of this Regulation], provide the relevant
        scientific committee with a mandate to prepare guidelines that shall be ready before
        … [date of application of this Regulation]. The mandate for the committee shall encompass
        at least a benefit-risk assessment of the presence of phthalates which belong to either of the
        groups of substances referred to in points (a) and (b) of Section 10.4.1. The benefit-risk
        assessment shall take into account the intended purpose and context of the use of the
        device, as well as any available alternative substances and alternative materials, designs or
        medical treatments. When deemed appropriate on the basis of the latest scientific evidence,
        but at least every five years, the guidelines shall be updated.
10.4.4. Guidelines on other CMR and endocrine-disrupting substances
        Subsequently, the Commission shall mandate the relevant scientific committee to prepare
        guidelines as referred to in Section 10.4.3. also for other substances referred to in points (a)
        and (b) of Section 10.4.1., where appropriate.
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ANNEX I                                         DGB 2C                                            EN
 ---pagebreak--- 10.4.5. Labelling
        Where devices, parts thereof or materials used therein as referred to in Section 10.4.1.
        contain substances referred to in points (a) or (b) of Section 10.4.1. in a concentration
        above 0,1 % weight by weight (w/w), the presence of those substances shall be labelled on
        the device itself and/or on the packaging for each unit or, where appropriate, on the sales
        packaging, with the list of such substances. If the intended use of such devices includes
        treatment of children or treatment of pregnant or breastfeeding women or treatment of
        other patient groups considered particularly vulnerable to such substances and/or materials,
        information on residual risks for those patient groups and, if applicable, on appropriate
        precautionary measures shall be given in the instructions for use.
10.5.   Devices shall be designed and manufactured in such a way as to reduce as far as possible
        the risks posed by the unintentional ingress of substances into the device taking into
        account the device and the nature of the environment in which it is intended to be used.
10.6.   Devices shall be designed and manufactured in such a way as to reduce as far as possible
        the risks linked to the size and the properties of particles which are or can be released into
        the patient's or user's body, unless they come into contact with intact skin only. Special
        attention shall be given to nanomaterials.
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ANNEX I                                         DGB 2C                                            EN
 ---pagebreak--- 11.     Infection and microbial contamination
11.1.   Devices and their manufacturing processes shall be designed in such a way as to eliminate
        or to reduce as far as possible the risk of infection to patients, users and, where applicable,
        other persons. The design shall:
        (a)    reduce as far as possible and appropriate the risks from unintended cuts and pricks,
               such as needle stick injuries,
        (b)    allow easy and safe handling,
        (c)    reduce as far as possible any microbial leakage from the device and/or microbial
               exposure during use, and
        (d)    prevent microbial contamination of the device or its content such as specimens or
               fluids.
11.2.   Where necessary devices shall be designed to facilitate their safe cleaning, disinfection,
        and/or re-sterilisation.
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ANNEX I                                         DGB 2C                                             EN
 ---pagebreak--- 11.3.   Devices labelled as having a specific microbial state shall be designed, manufactured and
        packaged to ensure that they remain in that state when placed on the market and remain so
        under the transport and storage conditions specified by the manufacturer.
11.4.   Devices delivered in a sterile state shall be designed, manufactured and packaged in
        accordance with appropriate procedures, to ensure that they are sterile when placed on the
        market and that, unless the packaging which is intended to maintain their sterile condition
        is damaged, they remain sterile, under the transport and storage conditions specified by the
        manufacturer, until that packaging is opened at the point of use. It shall be ensured that the
        integrity of that packaging is clearly evident to the final user.
11.5.   Devices labelled as sterile shall be processed, manufactured, packaged and, sterilised by
        means of appropriate, validated methods.
11.6.   Devices intended to be sterilised shall be manufactured and packaged in appropriate and
        controlled conditions and facilities.
11.7.   Packaging systems for non-sterile devices shall maintain the integrity and cleanliness of
        the product and, where the devices are to be sterilised prior to use, minimise the risk of
        microbial contamination; the packaging system shall be suitable taking account of the
        method of sterilisation indicated by the manufacturer.
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ANNEX I                                         DGB 2C                                           EN
 ---pagebreak--- 11.8.   The labelling of the device shall distinguish between identical or similar devices placed on
        the market in both a sterile and a non-sterile condition additional to the symbol used to
        indicate that devices are sterile.
12.     Devices incorporating a substance considered to be a medicinal product and devices that
        are composed of substances or of combinations of substances that are absorbed by or
        locally dispersed in the human body.
12.1.   In the case of devices referred to in the first subparagraph of Article 1(8), the quality,
        safety and usefulness of the substance which, if used separately, would be considered to be
        a medicinal product within the meaning of point (2) of Article 1 of Directive 2001/83/EC,
        shall be verified by analogy with the methods specified in Annex I to
        Directive 2001/83/EC, as required by the applicable conformity assessment procedure
        under this Regulation.
12.2.   Devices that are composed of substances or of combinations of substances that are
        intended to be introduced into the human body, and that are absorbed by or locally
        dispersed in the human body shall comply, where applicable and in a manner limited to the
        aspects not covered by this Regulation, with the relevant requirements laid down in
        Annex I to Directive 2001/83/EC for the evaluation of absorption, distribution,
        metabolism, excretion, local tolerance, toxicity, interaction with other devices, medicinal
        products or other substances and potential for adverse reactions, as required by the
        applicable conformity assessment procedure under this Regulation.
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ANNEX I                                         DGB 2C                                             EN
 ---pagebreak--- 13.     Devices incorporating materials of biological origin
13.1.   For devices manufactured utilising derivatives of tissues or cells of human origin which are
        non-viable or are rendered non-viable covered by this Regulation in accordance with
        point (g) of Article 1(6), the following shall apply:
        (a)   donation, procurement and testing of the tissues and cells shall be done in accordance
              with Directive 2004/23/EC;
        (b)   processing, preservation and any other handling of those tissues and cells or their
              derivatives shall be carried out so as to provide safety for patients, users and, where
              applicable, other persons. In particular, safety with regard to viruses and other
              transmissible agents shall be addressed by appropriate methods of sourcing and by
              implementation of validated methods of elimination or inactivation in the course of
              the manufacturing process;
        (c)   the traceability system for those devices shall be complementary and compatible with
              the traceability and data protection requirements laid down in Directive 2004/23/EC
              and in Directive 2002/98/EC.
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ANNEX I                                        DGB 2C                                             EN
 ---pagebreak--- 13.2.   For devices manufactured utilising tissues or cells of animal origin, or their derivatives,
        which are non-viable or rendered non-viable the following shall apply:
        (a)   where feasible taking into account the animal species, tissues and cells of animal
              origin, or their derivatives, shall originate from animals that have been subjected to
              veterinary controls that are adapted to the intended use of the tissues. Information on
              the geographical origin of the animals shall be retained by manufacturers;
        (b)   sourcing, processing, preservation, testing and handling of tissues, cells and
              substances of animal origin, or their derivatives, shall be carried out so as to provide
              safety for patients, users and, where applicable, other persons. In particular safety
              with regard to viruses and other transmissible agents shall be addressed by
              implementation of validated methods of elimination or viral inactivation in the
              course of the manufacturing process, except when the use of such methods would
              lead to unacceptable degradation compromising the clinical benefit of the device;
        (c)   in the case of devices manufactured utilising tissues or cells of animal origin, or their
              derivatives, as referred to in Regulation (EU) No 722/2012 the particular
              requirements laid down in that Regulation shall apply.
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ANNEX I                                         DGB 2C                                            EN
 ---pagebreak--- 13.3.   For devices manufactured utilising non-viable biological substances other than those
        referred to in Sections 13.1 and 13.2, the processing, preservation, testing and handling of
        those substances shall be carried out so as to provide safety for patients, users and, where
        applicable, other persons, including in the waste disposal chain. In particular, safety with
        regard to viruses and other transmissible agents shall be addressed by appropriate methods
        of sourcing and by implementation of validated methods of elimination or inactivation in
        the course of the manufacturing process.
14.     Construction of devices and interaction with their environment
14.1.   If the device is intended for use in combination with other devices or equipment the whole
        combination, including the connection system shall be safe and shall not impair the
        specified performance of the devices. Any restrictions on use applying to such
        combinations shall be indicated on the label and/or in the instructions for use. Connections
        which the user has to handle, such as fluid, gas transfer, electrical or mechanical coupling,
        shall be designed and constructed in such a way as to minimise all possible risks, such as
        misconnection.
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ANNEX I                                        DGB 2C                                            EN
 ---pagebreak--- 14.2.   Devices shall be designed and manufactured in such a way as to remove or reduce as far as
        possible:
        (a)   the risk of injury, in connection with their physical features, including the
              volume/pressure ratio, dimensional and where appropriate ergonomic features;
        (b)   risks connected with reasonably foreseeable external influences or environmental
              conditions, such as magnetic fields, external electrical and electromagnetic effects,
              electrostatic discharge, radiation associated with diagnostic or therapeutic
              procedures, pressure, humidity, temperature, variations in pressure and acceleration
              or radio signal interferences;
        (c)   the risks associated with the use of the device when it comes into contact with
              materials, liquids, and substances, including gases, to which it is exposed during
              normal conditions of use;
        (d)   the risks associated with the possible negative interaction between software and the
              IT environment within which it operates and interacts;
        (e)   the risks of accidental ingress of substances into the device;
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ANNEX I                                        DGB 2C                                            EN
 ---pagebreak---         (f)   the risks of reciprocal interference with other devices normally used in the
              investigations or for the treatment given; and
        (g)   risks arising where maintenance or calibration are not possible (as with implants),
              from ageing of materials used or loss of accuracy of any measuring or control
              mechanism.
14.3.   Devices shall be designed and manufactured in such a way as to minimise the risks of fire
        or explosion during normal use and in single fault condition. Particular attention shall be
        paid to devices the intended use of which includes exposure to or use in association with
        flammable or explosive substances or substances which could cause combustion.
14.4.   Devices shall be designed and manufactured in such a way that adjustment, calibration,
        and maintenance can be done safely and effectively.
14.5.   Devices that are intended to be operated together with other devices or products shall be
        designed and manufactured in such a way that the interoperability and compatibility are
        reliable and safe.
14.6    Any measurement, monitoring or display scale shall be designed and manufactured in line
        with ergonomic principles, taking account of the intended purpose, users and the
        environmental conditions in which the devices are intended to be used.
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ANNEX I                                         DGB 2C                                           EN
 ---pagebreak--- 14.7.   Devices shall be designed and manufactured in such a way as to facilitate their safe
        disposal and the safe disposal of related waste substances by the user, patient or other
        person. To that end, manufacturers shall identify and test procedures and measures as a
        result of which their devices can be safely disposed after use. Such procedures shall be
        described in the instructions for use.
15.     Devices with a diagnostic or measuring function
15.1.   Diagnostic devices and devices with a measuring function, shall be designed and
        manufactured in such a way as to provide sufficient accuracy, precision and stability for
        their intended purpose, based on appropriate scientific and technical methods. The limits of
        accuracy shall be indicated by the manufacturer.
15.2.   The measurements made by devices with a measuring function shall be expressed in legal
        units conforming to the provisions of Council Directive 80/181/EEC 1.
1
      Council Directive 80/181/EEC of 20 December 1979 on the approximation of the laws of
      the Member States relating to units of measurement and on the repeal of
      Directive 71/354/EEC (OJ L 039, 15.2.1980, p. 40).
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ANNEX I                                        DGB 2C                                            EN
 ---pagebreak--- 16.     Protection against radiation
16.1.   General
        (a)   Devices shall be designed, manufactured and packaged in such a way that exposure
              of patients, users and other persons to radiation is reduced as far as possible, and in a
              manner that is compatible with the intended purpose, whilst not restricting the
              application of appropriate specified levels for therapeutic and diagnostic purposes.
        (b)   The operating instructions for devices emitting hazardous or potentially hazardous
              radiation shall contain detailed information as to the nature of the emitted radiation,
              the means of protecting the patient and the user, and on ways of avoiding misuse and
              of reducing the risks inherent to installation as far as possible and appropriate.
              Information regarding the acceptance and performance testing, the acceptance
              criteria, and the maintenance procedure shall also be specified.
16.2.   Intended radiation
        (a)   Where devices are designed to emit hazardous, or potentially hazardous, levels of
              ionizing and/or non-ionizing radiation necessary for a specific medical purpose the
              benefit of which is considered to outweigh the risks inherent to the emission, it shall
              be possible for the user to control the emissions. Such devices shall be designed and
              manufactured to ensure reproducibility of relevant variable parameters within an
              acceptable tolerance.
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ANNEX I                                        DGB 2C                                             EN
 ---pagebreak---         (b)    Where devices are intended to emit hazardous, or potentially hazardous, ionizing
               and/or non-ionizing radiation, they shall be fitted, where possible, with visual
               displays and/or audible warnings of such emissions.
16.3.   Devices shall be designed and manufactured in such a way that exposure of patients, users
        and other persons to the emission of unintended, stray or scattered radiation is reduced as
        far as possible. Where possible and appropriate, methods shall be selected which reduce
        the exposure to radiation of patients, users and other persons who may be affected.
16.4.   Ionising radiation
        (a)    Devices intended to emit ionizing radiation shall be designed and manufactured
               taking into account the requirements of the Directive 2013/59/Euratom laying down
               basic safety standards for protection against the dangers arising from exposure to
               ionising radiation.
        (b)    Devices intended to emit ionising radiation shall be designed and manufactured in
               such a way as to ensure that, where possible, taking into account the intended use,
               the quantity, geometry and quality of the radiation emitted can be varied and
               controlled, and, if possible, monitored during treatment.
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ANNEX I                                        DGB 2C                                            EN
 ---pagebreak---         (c)    Devices emitting ionising radiation intended for diagnostic radiology shall be
               designed and manufactured in such a way as to achieve an image and/or output
               quality that are appropriate to the intended medical purpose whilst minimising
               radiation exposure of the patient and user.
        (d)    Devices that emit ionising radiation and are intended for therapeutic radiology shall
               be designed and manufactured in such a way as to enable reliable monitoring and
               control of the delivered dose, the beam type, energy and, where appropriate, the
               quality of radiation.
17.     Electronic programmable systems – devices that incorporate electronic programmable
        systems and software that are devices in themselves
17.1.   Devices that incorporate electronic programmable systems, including software, or software
        that are devices in themselves, shall be designed to ensure repeatability, reliability and
        performance in line with their intended use. In the event of a single fault condition,
        appropriate means shall be adopted to eliminate or reduce as far as possible consequent
        risks or impairment of performance.
17.2.   For devices that incorporate software or for software that are devices in themselves, the
        software shall be developed and manufactured in accordance with the state of the art taking
        into account the principles of development life cycle, risk management, including
        information security, verification and validation.
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ANNEX I                                         DGB 2C                                            EN
 ---pagebreak--- 17.3.   Software referred to in this Section that is intended to be used in combination with mobile
        computing platforms shall be designed and manufactured taking into account the specific
        features of the mobile platform (e.g. size and contrast ratio of the screen) and the external
        factors related to their use (varying environment as regards level of light or noise).
17.4.   Manufacturers shall set out minimum requirements concerning hardware, IT networks
        characteristics and IT security measures, including protection against unauthorised access,
        necessary to run the software as intended.
18.     Active devices and devices connected to them
18.1.   For non-implantable active devices, in the event of a single fault condition, appropriate
        means shall be adopted to eliminate or reduce as far as possible consequent risks.
18.2.   Devices where the safety of the patient depends on an internal power supply shall be
        equipped with a means of determining the state of the power supply and an appropriate
        warning or indication for when the capacity of the power supply becomes critical. If
        necessary, such warning or indication shall be given prior to the power supply becoming
        critical.
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ANNEX I                                        DGB 2C                                             EN
 ---pagebreak--- 18.3.   Devices where the safety of the patient depends on an external power supply shall include
        an alarm system to signal any power failure.
18.4.   Devices intended to monitor one or more clinical parameters of a patient shall be equipped
        with appropriate alarm systems to alert the user of situations which could lead to death or
        severe deterioration of the patient's state of health.
18.5.   Devices shall be designed and manufactured in such a way as to reduce as far as possible
        the risks of creating electromagnetic interference which could impair the operation of the
        device in question or other devices or equipment in the intended environment.
18.6.   Devices shall be designed and manufactured in such a way as to provide a level of intrinsic
        immunity to electromagnetic interference such that is adequate to enable them to operate
        as intended.
18.7.   Devices shall be designed and manufactured in such a way as to avoid, as far as possible,
        the risk of accidental electric shocks to the patient, user or any other person, both during
        normal use of the device and in the event of a single fault condition in the device, provided
        the device is installed and maintained as indicated by the manufacturer.
18.8.   Devices shall be designed and manufactured in such a way as to protect, as far as possible,
        against unauthorised access that could hamper the device from functioning as intended.
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ANNEX I                                         DGB 2C                                            EN
 ---pagebreak--- 19.     Particular requirements for active implantable devices
19.1.   Active implantable devices shall be designed and manufactured in such a way as to remove
        or minimize as far as possible:
        (a)   risks connected with the use of energy sources with particular reference, where
              electricity is used, to insulation, leakage currents and overheating of the devices,
        (b)   risks connected with medical treatment, in particular those resulting from the use of
              defibrillators or high-frequency surgical equipment, and
        (c)   risks which may arise where maintenance and calibration are impossible, including:
              –      excessive increase of leakage currents,
              –      ageing of the materials used,
              –      excess heat generated by the device,
              –      decreased accuracy of any measuring or control mechanism.
19.2.   Active implantable devices shall be designed and manufactured in such a way as to ensure
        –     if applicable, the compatibility of the devices with the substances they are intended
              to administer, and
        –     the reliability of the source of energy.
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ANNEX I                                         DGB 2C                                            EN
 ---pagebreak--- 19.3.   Active implantable devices and, if appropriate, their component parts shall be identifiable
        to allow any necessary measure to be taken following the discovery of a potential risk in
        connection with the devices or their component parts.
19.4.   Active implantable devices shall bear a code by which they and their manufacturer can be
        unequivocally identified (particularly with regard to the type of device and its year of
        manufacture); it shall be possible to read this code, if necessary, without the need for a
        surgical operation.
20.     Protection against mechanical and thermal risks
20.1.   Devices shall be designed and manufactured in such a way as to protect patients and users
        against mechanical risks connected with, for example, resistance to movement, instability
        and moving parts.
20.2.   Devices shall be designed and manufactured in such a way as to reduce to the lowest
        possible level the risks arising from vibration generated by the devices, taking account of
        technical progress and of the means available for limiting vibrations, particularly at source,
        unless the vibrations are part of the specified performance.
20.3.   Devices shall be designed and manufactured in such a way as to reduce to the lowest
        possible level the risks arising from the noise emitted, taking account of technical progress
        and of the means available to reduce noise, particularly at source, unless the noise emitted
        is part of the specified performance.
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ANNEX I                                         DGB 2C                                            EN
 ---pagebreak--- 20.4.   Terminals and connectors to the electricity, gas or hydraulic and pneumatic energy
        supplies which the user or other person has to handle, shall be designed and constructed in
        such a way as to minimise all possible risks.
20.5.   Errors likely to be made when fitting or refitting certain parts which could be a source of
        risk shall be made impossible by the design and construction of such parts or, failing this,
        by information given on the parts themselves and/or their housings.
        The same information shall be given on moving parts and/or their housings where the
        direction of movement needs to be known in order to avoid a risk.
20.6.   Accessible parts of devices (excluding the parts or areas intended to supply heat or reach
        given temperatures) and their surroundings shall not attain potentially dangerous
        temperatures under normal conditions of use.
21.     Protection against the risks posed to the patient or user by devices supplying energy or
        substances
21.1.   Devices for supplying the patient with energy or substances shall be designed and
        constructed in such a way that the amount to be delivered can be set and maintained
        accurately enough to ensure the safety of the patient and of the user.
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ANNEX I                                        DGB 2C                                           EN
 ---pagebreak--- 21.2.   Devices shall be fitted with the means of preventing and/or indicating any inadequacies in
        the amount of energy delivered or substances delivered which could pose a danger.
        Devices shall incorporate suitable means to prevent, as far as possible, the accidental
        release of dangerous levels of energy or substances from an energy and/or substance
        source.
21.3.   The function of the controls and indicators shall be clearly specified on the devices. Where
        a device bears instructions required for its operation or indicates operating or adjustment
        parameters by means of a visual system, such information shall be understandable to the
        user and, as appropriate, the patient.
22.     Protection against the risks posed by medical devices intended by the manufacturer for use
        by lay persons
22.1.   Devices for use by lay persons shall be designed and manufactured in such a way that they
        perform appropriately for their intended purpose taking into account the skills and the
        means available to lay persons and the influence resulting from variation that can be
        reasonably anticipated in the lay person's technique and environment. The information and
        instructions provided by the manufacturer shall be easy for the lay person to understand
        and apply.
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ANNEX I                                        DGB 2C                                            EN
 ---pagebreak--- 22.2.   Devices for use by lay persons shall be designed and manufactured in such a way as to:
        –     ensure that the device can be used safely and accurately by the intended user at all
              stages of the procedure, if necessary after appropriate training and/or information,
        –     reduce, as far as possible and appropriate, the risk from unintended cuts and pricks
              such as needle stick injuries, and
        –     reduce as far as possible the risk of error by the intended user in the handling of the
              device and, if applicable, in the interpretation of the results.
22.3.   Devices for use by lay persons shall, where appropriate, include a procedure by which the
        lay person:
        –     can verify that, at the time of use, the device will perform as intended by the
              manufacturer, and
        –     if applicable, is warned if the device has failed to provide a valid result.
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ANNEX I                                         DGB 2C                                            EN
 ---pagebreak---                                            Chapter III
                     Requirements regarding the information
                                  supplied with the device
23.     Label and instructions for use
23.1.   General requirements regarding the information supplied by the manufacturer
        Each device shall be accompanied by the information needed to identify the device and its
        manufacturer, and by any safety and performance information relevant to the user, or any
        other person, as appropriate. Such information may appear on the device itself, on the
        packaging or in the instructions for use, and shall, if the manufacturer has a website, be
        made available and kept up to date on the website, taking into account the following:
        (a)   The medium, format, content, legibility, and location of the label and instructions for
              use shall be appropriate to the particular device, its intended purpose and the
              technical knowledge, experience, education or training of the intended user(s). In
              particular, instructions for use shall be written in terms readily understood by the
              intended user and, where appropriate, supplemented with drawings and diagrams.
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ANNEX I                                         DGB 2C                                            EN
 ---pagebreak---         (b) The information required on the label shall be provided on the device itself. If this is
            not practicable or appropriate, some or all of the information may appear on the
            packaging for each unit, and/or on the packaging of multiple devices.
        (c) Labels shall be provided in a human-readable format and may be supplemented by
            machine-readable information, such as radio-frequency identification ('RFID') or bar
            codes.
        (d) Instructions for use shall be provided together with devices. By way of exception,
            instructions for use shall not be required for class I and class IIa devices if such
            devices can be used safely without any such instructions and unless otherwise
            provided for elsewhere in this Section.
        (e) Where multiple devices are supplied to a single user and/or location, a single copy of
            the instructions for use may be provided if so agreed by the purchaser who in any
            case may request further copies to be provided free of charge.
        (f) Instructions for use may be provided to the user in non-paper format (e.g. electronic)
            to the extent, and only under the conditions, set out in Regulation (EU) No 207/2012
            or in any subsequent implementing rules adopted pursuant to this Regulation.
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ANNEX I                                      DGB 2C                                              EN
 ---pagebreak---         (g)   Residual risks which are required to be communicated to the user and/or other person
              shall be included as limitations, contra-indications, precautions or warnings in the
              information supplied by the manufacturer.
        (h)   Where appropriate, the information supplied by the manufacturer shall take the form
              of internationally recognised symbols. Any symbol or identification colour used shall
              conform to the harmonised standards or CS. In areas for which no harmonised
              standards or CS exist, the symbols and colours shall be described in the
              documentation supplied with the device.
23.2.   Information on the label
        The label shall bear all of the following particulars:
        (a)   the name or trade name of the device;
        (b)   the details strictly necessary for a user to identify the device, the contents of the
              packaging and, where it is not obvious for the user, the intended purpose of the
              device;
        (c)   the name, registered trade name or registered trade mark of the manufacturer and the
              address of its registered place of business;
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ANNEX I                                         DGB 2C                                              EN
 ---pagebreak---         (d) if the manufacturer has its registered place of business outside the Union, the name
            of the authorised representative and address of the registered place of business of the
            authorised representative;
        (e) where applicable, an indication that the device contains or incorporates:
            –      a medicinal substance, including a human blood or plasma derivative, or
            –      tissues or cells, or their derivatives, of human origin, or
            –      tissues or cells of animal origin, or their derivatives, as referred to in
                   Regulation (EU) No 722/2012;
        (f) where applicable, information labelled in accordance with Section 10.4.5.;
        (g) the lot number or the serial number of the device preceded by the words LOT
            NUMBER or SERIAL NUMBER or an equivalent symbol, as appropriate;
        (h) the UDI carrier referred to in Article 27(4) and Part C of Annex VII;
        (i) an unambiguous indication of t the time limit for using or implanting the device
            safely, expressed at least in terms of year and month, where this is relevant;
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ANNEX I                                        DGB 2C                                         EN
 ---pagebreak---         (j) where there is no indication of the date until when it may be used safely, the date of
            manufacture. This date of manufacture may be included as part of the lot number or
            serial number, provided the date is clearly identifiable;
        (k) an indication of any special storage and/or handling condition that applies;
        (l) if the device is supplied sterile, an indication of its sterile state and the sterilisation
            method;
        (m) warnings or precautions to be taken that need to be brought to the immediate
            attention of the user of the device, and to any other person. This information may be
            kept to a minimum in which case more detailed information shall appear in the
            instructions for use, taking into account the intended users;
        (n) if the device is intended for single use, an indication of that fact. A manufacturer's
            indication of single use shall be consistent across the Union;
        (o) if the device is a single-use device that has been reprocessed, an indication of that
            fact, the number of reprocessing cycles already performed, and any limitation as
            regards the number of reprocessing cycles;
        (p) if the device is custom-made, the words 'custom-made device';
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ANNEX I                                        DGB 2C                                                EN
 ---pagebreak---         (q)  an indication that the device is a medical device. If the device is intended for clinical
             investigation only, the words 'exclusively for clinical investigation';
        (r)  in the case of devices that are composed of substances or of combinations of
             substances that are intended to be introduced into the human body via a body orifice
             or applied to the skin and that are absorbed by or locally dispersed in the human
             body, the overall qualitative composition of the device and quantitative information
             on the main constituent or constituents responsible for achieving the principal
             intended action;
        (s)  for active implantable devices, the serial number, and for other implantable devices,
             the serial number or the lot number.
23.3.   Information on the packaging which maintains the sterile condition of a device ('sterile
        packaging')
        The following particulars shall appear on the sterile packaging:
        (a)  an indication permitting the sterile packaging to be recognised as such,
        (b)  a declaration that the device is in a sterile condition,
        (c)  the method of sterilisation,
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ANNEX I                                        DGB 2C                                            EN
 ---pagebreak---         (d)   the name and address of the manufacturer,
        (e)   a description of the device,
        (f)   if the device is intended for clinical investigations, the words 'exclusively for clinical
              investigations',
        (g)   if the device is custom-made, the words 'custom-made device',
        (h)   the month and year of manufacture,
        (i)   an unambiguous indication of the time limit for using or implanting the device safely
              expressed at least in terms of year and month, and
        (j)   an instruction to check the instructions for use for what to do if the sterile packaging
              is damaged or unintentionally opened before use.
23.4.   Information in the instructions for use
        The instructions for use shall contain all of the following particulars:
        (a)   the particulars referred to in points (a), (c), (e), (f), (k), (l), (n) and (r) of
              Section 23.2;
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ANNEX I                                         DGB 2C                                             EN
 ---pagebreak---         (b) the device's intended purpose with a clear specification of indications, contra-
            indications, the patient target group or groups, and of the intended users, as
            appropriate;
        (c) where applicable, a specification of the clinical benefits to be expected.
        (d) where applicable, links to the summary of safety and clinical performance referred to
            in Article 32;
        (e) the performance characteristics of the device;
        (f) where applicable, information allowing the healthcare professional to verify if the
            device is suitable and select the corresponding software and accessories;
        (g) any residual risks, contra-indications and any undesirable side-effects, including
            information to be conveyed to the patient in this regard;
        (h) specifications the user requires to use the device appropriately, e.g. if the device has
            a measuring function, the degree of accuracy claimed for it;
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ANNEX I                                       DGB 2C                                             EN
 ---pagebreak---         (i) details of any preparatory treatment or handling of the device before it is ready for
            use or during its use, such as sterilisation, final assembly, calibration, etc., including
            the levels of disinfection required to ensure patient safety and all available methods
            for achieving those levels of disinfection;
        (j) any requirements for special facilities, or special training, or particular qualifications
            of the device user and/or other persons;
        (k) the information needed to verify whether the device is properly installed and is ready
            to perform safely and as intended by the manufacturer, together with, where relevant:
            –     details of the nature, and frequency, of preventive and regular maintenance,
                  and of any preparatory cleaning or disinfection,
            –     identification of any consumable components and how to replace them,
            –     information on any necessary calibration to ensure that the device operates
                  properly and safely during its intended lifetime, and
            –     methods for eliminating the risks encountered by persons involved in
                  installing, calibrating or servicing devices;
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ANNEX I                                       DGB 2C                                               EN
 ---pagebreak---         (l) if the device is supplied sterile, instructions in the event of the sterile packaging
            being damaged or unintentionally opened before use;
        (m) if the device is supplied non-sterile with the intention that it is sterilised before use,
            the appropriate instructions for sterilisation;
        (n) if the device is reusable, information on the appropriate processes for allowing reuse,
            including cleaning, disinfection, packaging and, where appropriate, the validated
            method of re-sterilisation appropriate to the Member State or Member States in
            which the device has been placed on the market. Information shall be provided to
            identify when the device should no longer be reused, e.g. signs of material
            degradation or the maximum number of allowable reuses;
        (o) an indication, if appropriate, that a device can be reused only if it is reconditioned
            under the responsibility of the manufacturer to comply with the general safety and
            performance requirements;
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ANNEX I                                        DGB 2C                                              EN
 ---pagebreak---         (p) if the device bears an indication that it is for single use, information on known
            characteristics and technical factors known to the manufacturer that could pose a risk
            if the device were to be re-used. This information shall be based on a specific section
            of the manufacturer's risk management documentation, where such characteristics
            and technical factors shall be addressed in detail. If in accordance with point (d) of
            Section 23.1. no instructions for use are required, this information shall be made
            available to the user upon request;
        (q) for devices intended for use together with other devices and/or general purpose
            equipment:
            –      information to identify such devices or equipment, in order to obtain a safe
                   combination, and/or
            –      information on any known restrictions to combinations of devices and
                   equipment;
        (r) if the device emits radiation for medical purposes:
            –      detailed information as to the nature, type and where appropriate, the intensity
                   and distribution of the emitted radiation,
            –      the means of protecting the patient, user, or other person from unintended
                   radiation during use of the device;
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ANNEX I                                      DGB 2C                                             EN
 ---pagebreak---         (s) information that allows the user and/or patient to be informed of any warnings,
            precautions, contra-indications, measures to be taken and limitations of use regarding
            the device. That information shall, where relevant, allow the user to brief the patient
            about any warnings, precautions, contra-indications, measures to be taken and
            limitations of use regarding the device. The information shall cover, where
            appropriate:
            –     warnings, precautions and/or measures to be taken in the event of malfunction
                  of the device or changes in its performance that may affect safety,
            –     warnings, precautions and/or measures to be taken as regards the exposure to
                  reasonably foreseeable external influences or environmental conditions, such
                  as magnetic fields, external electrical and electromagnetic effects, electrostatic
                  discharge, radiation associated with diagnostic or therapeutic procedures,
                  pressure, humidity, or temperature,
            –     warnings, precautions and/or measures to be taken as regards the risks of
                  interference posed by the reasonably foreseeable presence of the device during
                  specific diagnostic investigations, evaluations, or therapeutic treatment or other
                  procedures such as electromagnetic interference emitted by the device affecting
                  other equipment,
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ANNEX I                                     DGB 2C                                             EN
 ---pagebreak---             –     if the device is intended to administer medicinal products, tissues or cells of
                  human or animal origin, or their derivatives, or biological substances, any
                  limitations or incompatibility in the choice of substances to be delivered,
            –     warnings, precautions and/or limitations related to the medicinal substance or
                  biological material that is incorporated into the device as an integral part of the
                  device; and
            –     precautions related to materials incorporated into the device that contain or
                  consist of CMR substances or endocrine-disrupting substances, or that could
                  result in sensitisation or an allergic reaction by the patient or user;
        (t) in the case of devices that are composed of substances or of combinations of
            substances that are intended to be introduced into the human body and that are
            absorbed by or locally dispersed in the human body, warnings and precautions,
            where appropriate, related to the general profile of interaction of the device and its
            products of metabolism with other devices, medicinal products and other substances
            as well as contra-indications, undesirable side-effects and risks relating to overdose;
        (u) in the case of implantable devices, the overall qualitative and quantitative
            information on the materials and substances to which patients can be exposed;
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ANNEX I                                       DGB 2C                                            EN
 ---pagebreak---         (v) warnings or precautions to be taken in order to facilitate the safe disposal of the
            device, its accessories and the consumables used with it, if any. This information
            shall cover, where appropriate:
            –      infection or microbial hazards such as explants, needles or surgical equipment
                   contaminated with potentially infectious substances of human origin, and
            –      physical hazards such as from sharps.
            If in accordance with the point (d) of Section 23.1 no instructions for use are
            required, this information shall be made available to the user upon request;
        (w) for devices intended for use by lay persons, the circumstances in which the user
            should consult a healthcare professional;
        (x) for the devices covered by this Regulation pursuant to Article 1(2), information
            regarding the absence of a clinical benefit and the risks related to use of the device;
        (y) date of issue of the instructions for use or, if they have been revised, date of issue and
            identifier of the latest revision of the instructions for use;
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ANNEX I                                        DGB 2C                                            EN
 ---pagebreak---         (z)  a notice to the user and/or patient that any serious incident that has occurred in
             relation to the device should be reported to the manufacturer and the competent
             authority of the Member State in which the user and/or patient is established;
        (aa) information to be supplied to the patient with an implanted device in accordance with
             Article 18;
        (ab) for devices that incorporate electronic programmable systems, including software, or
             software that are devices in themselves, minimum requirements concerning
             hardware, IT networks characteristics and IT security measures, including protection
             against unauthorised access, necessary to run the software as intended.
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ANNEX I                                       DGB 2C                                            EN
 ---pagebreak---                                               ANNEX II
                                  TECHNICAL DOCUMENTATION
The technical documentation and, if applicable, the summary thereof to be drawn up by the
manufacturer shall be presented in a clear, organised, readily searchable and unambiguous manner
and shall include in particular the elements listed in this Annex.
1.       DEVICE DESCRIPTION AND SPECIFICATION, INCLUDING VARIANTS AND
         ACCESSORIES
1.1.     Device description and specification
         (a)   product or trade name and a general description of the device including its intended
               purpose and intended users;
         (b)   the Basic UDI-DI as referred to in Part C of Annex VI assigned by the manufacturer
               to the device in question, as soon as identification of this device becomes based on a
               UDI system, or otherwise a clear identification by means of product code, catalogue
               number or other unambiguous reference allowing traceability;
         (c)   the intended patient population and medical conditions to be diagnosed, treated
               and/or monitored and other considerations such as patient selection criteria,
               indications, contra-indications, warnings;
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ANNEX II                                        DGB 2C                                           EN
 ---pagebreak---         (d) principles of operation of the device and its mode of action, scientifically
            demonstrated if necessary;
        (e) the rationale for the qualification of the product as a device;
        (f) the risk class of the device and the justification for the classification rule(s) applied
            in accordance with Annex VIII;
        (g) an explanation of any novel features;
        (h) a description of the accessories for a device, other devices and other products that are
            not devices, which are intended to be used in combination with it;
        (i) a description or complete list of the various configurations/variants of the device that
            are intended to be made available on the market;
        (j) a general description of the key functional elements, e.g. its parts/components
            (including software if appropriate), its formulation, its composition, its functionality
            and, where relevant, its qualitative and quantitative composition. Where appropriate,
            this shall include labelled pictorial representations (e.g. diagrams, photographs, and
            drawings), clearly indicating key parts/components, including sufficient explanation
            to understand the drawings and diagrams;
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ANNEX II                                      DGB 2C                                               EN
 ---pagebreak---         (k)  a description of the raw materials incorporated into key functional elements and
             those making either direct contact with the human body or indirect contact with the
             body, e.g., during extracorporeal circulation of body fluids;
        (l)  technical specifications, such as features, dimensions and performance attributes, of
             the device and any variants/configurations and accessories that would typically
             appear in the product specification made available to the user, for example in
             brochures, catalogues and similar publications.
1.2.    Reference to previous and similar generations of the device
        (a)  an overview of the previous generation or generations of the device produced by the
             manufacturer, where such devices exist;
        (b)  an overview of identified similar devices available on the Union or international
             markets, where such devices exist.
2.      INFORMATION TO BE SUPPLIED BY THE MANUFACTURER
        A complete set of:
        –    the label or labels on the device and on its packaging, such as single unit packaging,
             sales packaging, transport packaging in case of specific management conditions, in
             the languages accepted in the Member States where the device is envisaged to be
             sold; and
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ANNEX II                                      DGB 2C                                           EN
 ---pagebreak---         –    the instructions for use in the languages accepted in the Member States where the
             device is envisaged to be sold.
3.      DESIGN AND MANUFACTURING INFORMATION
        (a)  information to allow the design stages applied to the device to be understood;
        (b)  complete information and specifications, including the manufacturing processes and
             their validation, their adjuvants, the continuous monitoring and the final product
             testing. Data shall be fully included in the technical documentation;
        (c)  identification of all sites, including suppliers and sub-contractors, where design and
             manufacturing activities are performed.
4.      GENERAL SAFETY AND PERFORMANCE REQUIREMENTS
        The documentation shall contain information for the demonstration of conformity with the
        general safety and performance requirements set out in Annex I that are applicable to the
        device taking into account its intended purpose, and shall include a justification, validation
        and verification of the solutions adopted to meet those requirements. The demonstration of
        conformity shall include:
        (a)  the general safety and performance requirements that apply to the device and an
             explanation as to why others do not apply;
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ANNEX II                                        DGB 2C                                           EN
 ---pagebreak---         (b)  the method or methods used to demonstrate conformity with each applicable general
             safety and performance requirement;
        (c)  the harmonised standards, CS or other solutions applied; and
        (d)  the precise identity of the controlled documents offering evidence of conformity with
             each harmonised standard, CS or other method applied to demonstrate conformity
             with the general safety and performance requirements. The information referred to
             under this point shall incorporate a cross-reference to the location of such evidence
             within the full technical documentation and, if applicable, the summary technical
             documentation.
5.      BENEFIT-RISK ANALYSIS AND RISK MANAGEMENT
        The documentation shall contain information on:
        (a)  the benefit-risk analysis referred to in Sections 1 and 8 of Annex I, and
        (b)  the solutions adopted and the results of the risk management referred to in Section 3
             of Annex I.
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ANNEX II                                      DGB 2C                                            EN
 ---pagebreak--- 6.      PRODUCT VERIFICATION AND VALIDATION
        The documentation shall contain the results and critical analyses of all verifications and
        validation tests and/or studies undertaken to demonstrate conformity of the device with the
        requirements of this Regulation and in particular the applicable general safety and
        performance requirements.
6.1.    Pre-clinical and clinical data
        (a)   results of tests, such as engineering, laboratory, simulated use and animal tests, and
              evaluation of published literature applicable to the device, taking into account its
              intended purpose, or to similar devices, regarding the pre-clinical safety of the device
              and its conformity with the specifications;
        (b)   detailed information regarding test design, complete test or study protocols, methods
              of data analysis, in addition to data summaries and test conclusions regarding in
              particular:
              –     the biocompatibility of the device including the identification of all materials in
                    direct or indirect contact with the patient or user;
              –     physical, chemical and microbiological characterisation;
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ANNEX II                                        DGB 2C                                            EN
 ---pagebreak---              –      electrical safety and electromagnetic compatibility;
             –      software verification and validation (describing the software design and
                    development process and evidence of the validation of the software, as used in
                    the finished device. This information shall typically include the summary
                    results of all verification, validation and testing performed both in-house and in
                    a simulated or actual user environment prior to final release. It shall also
                    address all of the different hardware configurations and, where applicable,
                    operating systems identified in the information supplied by the manufacturer);
             –      stability, including shelf life; and
             –      performance and safety.
             Where applicable, conformity with the provisions of Directive 2004/10/EC of the
             European Parliament and of the Council 1 shall be demonstrated.
             Where no new testing has been undertaken, the documentation shall incorporate a
             rationale for that decision. An example of such a rationale would be that.
             biocompatibility testing on identical materials was conducted when those materials
             were incorporated in a previous version of the device that has been legally placed on
             the market or put into service;
1
      Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004
      on the harmonisation of laws, regulations and administrative provisions relating to the
      application of the principles of good laboratory practice and the verification of their
      applications for tests on chemical substances (OJ L 50, 20.2.2004, p. 44).
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ANNEX II                                         DGB 2C                                          EN
 ---pagebreak---         (c)  the clinical evaluation report and its updates and the clinical evaluation plan referred
             to in Article 61(12) and Part A of Annex XIV;
        (d)  the PMCF plan and PMCF evaluation report referred to in Part B of Annex XIV or a
             justification why a PMCF is not applicable.
6.2.    Additional information required in specific cases
        (a)  Where a device incorporates, as an integral part, a substance which, if used
             separately, may be considered to be a medicinal product within the meaning of point
             2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived from
             human blood or human plasma, as referred to in the first subparagraph of
             Article 1(8), a statement indicating this fact. In this case, the documentation shall
             identify the source of that substance and contain the data of the tests conducted to
             assess its safety, quality and usefulness, taking account of the intended purpose of the
             device.
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ANNEX II                                      DGB 2C                                             EN
 ---pagebreak---         (b) Where a device is manufactured utilising tissues or cells of human or animal origin,
            or their derivatives, and is covered by this Regulation in accordance with points (f)
            and (g) of Article 1(6, and where a device incorporates, as an integral part, tissues or
            cells of human origin or their derivatives that have an action ancillary to that of the
            device and is covered by this Regulation in accordance with the first subparagraph of
            Article 1(10), a statement indicating this fact. In such a case, the documentation shall
            identify all materials of human or animal origin used and provide detailed
            information concerning the conformity with Sections 13.1. or 13.2., respectively, of
            Annex I.
        (c) In the case of devices that are composed of substances or combinations of substances
            that are intended to be introduced into the human body and that are absorbed by or
            locally dispersed in the human body, detailed information, including test design,
            complete test or study protocols, methods of data analysis, and data summaries and
            test conclusions, regarding studies in relation to:
            –      absorption, distribution, metabolism and excretion;
            –      possible interactions of those substances, or of their products of metabolism in
                   the human body, with other devices, medicinal products or other substances,
                   considering the target population, and its associated medical conditions;
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ANNEX II                                      DGB 2C                                             EN
 ---pagebreak---             –      local tolerance; and
            –      toxicity, including single-dose toxicity, repeat-dose toxicity, genotoxicity,
                   carcinogenicity and reproductive and developmental toxicity, as applicable
                   depending on the level and nature of exposure to the device.
            In the absence of such studies, a justification shall be provided.
        (d) In the case of devices containing CMR or endocrine-disrupting substances referred to
            in Section 10.4.1 of Annex I, the justification referred to in Section 10.4.2 of that
            Annex.
        (e) In the case of devices placed on the market in a sterile or defined microbiological
            condition, a description of the environmental conditions for the relevant
            manufacturing steps. In the case of devices placed on the market in a sterile
            condition, a description of the methods used, including the validation reports, with
            respect to packaging, sterilisation and maintenance of sterility. The validation report
            shall address bioburden testing, pyrogen testing and, if applicable, testing for
            sterilant residues.
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ANNEX II                                      DGB 2C                                             EN
 ---pagebreak---         (f) In the case of devices placed on the market with a measuring function, a description
            of the methods used in order to ensure the accuracy as given in the specifications.
        (g) If the device is to be connected to other device(s) in order to operate as intended, a
            description of this combination/configuration including proof that it conforms to the
            general safety and performance requirements when connected to any such device(s)
            having regard to the characteristics specified by the manufacturer.
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ANNEX II                                     DGB 2C                                            EN
 ---pagebreak---                                              ANNEX III
          TECHNICAL DOCUMENTATION ON POST-MARKET SURVEILLANCE
The technical documentation on post-market surveillance to be drawn up by the manufacturer in
accordance with Articles 83 to 86 shall be presented in a clear, organised, readily searchable and
unambiguous manner and shall include in particular the elements described in this Annex.
1.1.    The post-market surveillance plan drawn up in accordance with Article 84.
        The manufacturer shall prove in a post-market surveillance plan that it complies with the
        obligation referred to in Article 83.
        (a)   The post-market surveillance plan shall address the collection and utilization of
              available information, in particular:
              –     information concerning serious incidents, including information from PSURs,
                    and field safety corrective actions;
              –     records referring to non-serious incidents and data on any undesirable
                    side-effects;
              –     information from trend reporting;
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ANNEX III                                      DGB 2C                                            EN
 ---pagebreak---             –    relevant specialist or technical literature, databases and/or registers;
            –    information, including feedbacks and complaints, provided by users,
                 distributors and importers; and
            –    publicly available information about similar medical devices.
        (b) The post-market surveillance plan shall cover at least:
            –    a proactive and systematic process to collect any information referred to in
                 point (a). The process shall allow a correct characterisation of the performance
                 of the devices and shall also allow a comparison to be made between the device
                 and similar products available on the market;
            –    effective and appropriate methods and processes to assess the collected data;
            –    suitable indicators and threshold values that shall be used in the continuous
                 reassessment of the benefit-risk analysis and of the risk management as
                 referred to in Section 3 of Annex I;
            –    effective and appropriate methods and tools to investigate complaints and
                 analyse market-related experience collected in the field;
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ANNEX III                                   DGB 2C                                           EN
 ---pagebreak---               –     methods and protocols to manage the events subject to the trend report as
                    provided for in Article 88, including the methods and protocols to be used to
                    establish any statistically significant increase in the frequency or severity of
                    incidents as well as the observation period;
              –     methods and protocols to communicate effectively with competent authorities,
                    notified bodies, economic operators and users;
              –     reference to procedures to fulfil the manufacturers obligations laid down in
                    Articles 83, 84 and 86;
              –     systematic procedures to identify and initiate appropriate measures including
                    corrective actions;
              –     effective tools to trace and identify devices for which corrective actions might
                    be necessary; and
              –     a PMCF plan as referred to in Part B of Annex XIV, or a justification as to why
                    a PMCF is not applicable.
1.2.    The PSUR referred to in Article 86 and the post-market surveillance report referred to in
        Article 85.
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ANNEX III                                       DGB 2C                                             EN
 ---pagebreak---                                             ANNEX IV
                             EU DECLARATION OF CONFORMITY
The EU declaration of conformity shall contain all of the following information:
1.      Name, registered trade name or registered trade mark and, if already issued, SRN as
        referred to in Article 31 of the manufacturer, and, if applicable, its authorised
        representative, and the address of their registered place of business where they can be
        contacted and their location be established;
2.      A statement that the EU declaration of conformity is issued under the sole responsibility of
        the manufacturer;
3.      The Basic UDI-DI as referred to in Part C of Annex VI;
4.      Product and trade name, product code, catalogue number or other unambiguous reference
        allowing identification and traceability of the device covered by the EU declaration of
        conformity, such as a photograph, where appropriate, as well as its intended purpose.
        Except for the product or trade name, the information allowing identification and
        traceability may be provided by the Basic UDI-DI referred to in point 3;
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ANNEX IV                                       DGB 2C                                           EN
 ---pagebreak--- 5.      Risk class of the device in accordance with the rules set out in Annex VIII;
6.      A statement that the device that is covered by the present declaration is in conformity with
        this Regulation and, if applicable, with any other relevant Union legislation that provides
        for the issuing of an EU declaration of conformity;
7.      References to any CS used and in relation to which conformity is declared;
8.      Where applicable, the name and identification number of the notified body, a description
        of the conformity assessment procedure performed and identification of the certificate or
        certificates issued;
9.      Where applicable, additional information;
10.     Place and date of issue of the declaration, name and function of the person who signed it as
        well as an indication for, and on behalf of whom, that person signed, signature.
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ANNEX IV                                       DGB 2C                                            EN
 ---pagebreak---                                            ANNEX V
                               CE MARKING OF CONFORMITY
1.      The CE marking shall consist of the initials 'CE' taking the following form:
2.      If the CE marking is reduced or enlarged, the proportions given in the above graduated
        drawing shall be respected.
3.      The various components of the CE marking shall have substantially the same vertical
        dimension, which may not be less than 5 mm. This minimum dimension may be waived
        for small-scale devices.
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ANNEX V                                      DGB 2C                                           EN
 ---pagebreak---                                              ANNEX VI
                               INFORMATION TO BE SUBMITTED
                            UPON THE REGISTRATION OF DEVICES
                   AND ECONOMIC OPERATORS IN ACCORDANCE WITH
                       ARTICLES 29(4) AND 31, CORE DATA ELEMENTS
                          TO BE PROVIDED TO THE UDI DATABASE
                                   TOGETHER WITH THE UDI-DI
                        IN ACCORDANCE WITH ARTICLES 28 AND 29,
                                      AND THE UDI SYSTEM
                                               PART A
                               INFORMATION TO BE SUBMITTED
          UPON THE REGISTRATION OF DEVICES AND ECONOMIC OPERATORS
                       IN ACCORDANCE WITH ARTICLES 29(4) AND 31
Manufacturers or, when applicable, authorised representatives, and, when applicable, importers
shall submit the information referred to in Section 1 and shall ensure that the information on their
devices referred to in Section 2 is complete, correct and updated by the relevant party.
1.       Information relating to the economic operator
1.1.     type of economic operator(manufacturer, authorised representative, or importer),
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ANNEX VI                                       DGB 2C                                            EN
 ---pagebreak--- 1.2.    name, address and contact details of the economic operator,
1.3.    where submission of information is carried out by another person on behalf of any of the
        economic operators mentioned under Section 1.1, the name, address and contact details of
        that person,
1.4.    name address and contact details of the person or persons responsible for regulatory
        compliance referred to in Article 15.
2.      Information relating to the device
2.1.    Basic UDI-DI,
2.2.    type, number and expiry date of the certificate issued by the notified body and the name or
        identification number of that notified body and the link to the information that appears on
        the certificate and was entered by the notified body in the electronic system on notified
        bodies and certificates,
2.3.    Member State in which the device is to or has been placed on the market in the Union,
2.4.    in the case of class IIa, class IIb or class III devices: Member States where the device is or
        is to be made available,
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ANNEX VI                                         DGB 2C                                           EN
 ---pagebreak--- 2.5.    risk class of the device,
2.6.    reprocessed single-use device (y/n),
2.7.    presence of a substance which, if used separately, may be considered to be a medicinal
        product and name of that substance,
2.8.    presence of a substance which, if used separately, may be considered to be a medicinal
        product derived from human blood or human plasma and name of this substance,
2.9.    presence of tissues or cells of human origin, or their derivatives (y/n),
2.10.   presence of tissues or cells of animal origin, or their derivatives, as referred to in
        Regulation (EU) No 722/2012 (y/n),
2.11.   where applicable, the single identification number of the clinical investigation or
        investigations conducted in relation to the device or a link to the clinical investigation
        registration in the electronic system on clinical investigations,
2.12.   in the case of devices listed in Annex XVI, specification as to whether the intended
        purpose of the device is other than a medical purpose,
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ANNEX VI                                       DGB 2C                                              EN
 ---pagebreak--- 2.13.   in the case of devices designed and manufactured by another legal or natural person as
        referred in Article 10(15), the name, address and contact details of that legal or natural
        person,
2.14.   in the case of class III or implantable devices, the summary of safety and clinical
        performance,
2.15.   status of the device (on the market, no longer placed on the market, recalled, field safety
        corrective action initiated).
                                               PART B
                          CORE DATA ELEMENTS TO BE PROVIDED
                   TO THE UDI DATABASE TOGETHER WITH THE UDI-DI
                         IN ACCORDANCE WITH ARTICLES 28 AND 29
The manufacturer shall provide to the UDI database the UDI-DI and all of the following
information relating to the manufacturer and the device:
1.      quantity per package configuration,
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ANNEX VI                                        DGB 2C                                            EN
 ---pagebreak--- 2.      the Basic UDI-DI as referred to in Article 29 and any additional UDI-DIs,
3.      the manner in which production of the device is controlled (expiry date or manufacturing
        date, lot number, serial number),
4.      if applicable, the unit of use UDI-DI (where a UDI is not labelled on the device at the level
        of its unit of use, a 'unit of use' DI shall be assigned so as to associate the use of a device
        with a patient),
5.      name and address of the manufacturer (as indicated on the label),
6.      the SRN issued in accordance with Article 31(2),
7.      if applicable, name and address of the authorised representative (as indicated on the label),
8.      the medical device nomenclature code as provided for in Article 26,
9.      risk class of the device,
10.     if applicable, name or trade name,
11.     if applicable, device model, reference, or catalogue number,
12.     if applicable, clinical size (including volume, length, gauge, diameter),
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ANNEX VI                                          DGB 2C                                             EN
 ---pagebreak--- 13.     additional product description (optional),
14.     if applicable, storage and/or handling conditions (as indicated on the label or in the
        instructions for use),
15.     if applicable, additional trade names of the device,
16.     labelled as a single-use device (y/n),
17.     if applicable, the maximum number of reuses,
18.     device labelled sterile (y/n),
19.     need for sterilisation before use (y/n),
20.     containing latex (y/n),
21.     where applicable, information labelled in accordance with Section 10.4.5 of Annex I,
22.     URL for additional information, such as electronic instructions for use (optional),
23.     if applicable, critical warnings or contra-indications,
24.     status of the device (on the market, no longer placed on the market, recalled, field safety
        corrective action initiated).
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ANNEX VI                                        DGB 2C                                           EN
 ---pagebreak---                                                  PART C
                                            The UDI System
1.      Definitions
        Automatic identification and data capture ('AIDC')
        AIDC is a technology used to automatically capture data. AIDC technologies include bar
        codes, smart cards, biometrics and RFID.
        Basic UDI-DI
        The Basic UDI-DI is the primary identifier of a device model. It is the DI assigned at the
        level of the device unit of use. It is the main key for records in the UDI database and is
        referenced in relevant certificates and EU declarations of conformity.
        Unit of Use DI
        The Unit of Use DI serves to associate the use of a device with a patient in instances in
        which a UDI is not labelled on the individual device at the level of its unit of use, for
        example in the event of several units of the same device being packaged together.
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ANNEX VI                                         DGB 2C                                           EN
 ---pagebreak---         Configurable device
        A configurable device is a device that consists of several components which can be
        assembled by the manufacturer in multiple configurations. Those individual components
        may be devices in themselves.
        Configurable devices include computed tomography (CT) systems, ultrasound systems,
        anaesthesia systems, physiological Monitoring systems, radiology information
        systems (RIS).
        Configuration
        Configuration is a combination of items of equipment, as specified by the manufacturer,
        that operate together as a device to achieve an intended purpose. The combination of items
        may be modified, adjusted or customized to meet specific needs.
        Configurations include inter alia:
        –     gantries, tubes, tables, consoles and other items of equipment that can be
              configured/combined to deliver an intended function in computed tomography.
        –     ventilators, breathing circuits, vaporizers combined to deliver an intended function in
              anaesthesia.
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ANNEX VI                                        DGB 2C                                          EN
 ---pagebreak---         UDI-DI
        The UDI-DI is a unique numeric or alphanumeric code specific to a model of device and
        that is also used as the 'access key' to information stored in a UDI database.
        Human Readable Interpretation ('HRI')
        HRI is a legible interpretation of the data characters encoded in the UDI carrier.
        Packaging levels
        Packaging levels means the various levels of device packaging that contain a defined
        quantity of devices, such as a carton or case.
        UDI-PI
        The UDI-PI is a numeric or alphanumeric code that identifies the unit of device
        production.
        The different types of UDI-PIs include serial number, lot number, software identification
        and manufacturing or expiry date or both types of date.
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ANNEX VI                                         DGB 2C                                        EN
 ---pagebreak---         Radio Frequency Identification RFID
        RFID is a technology that uses communication through the use of radio waves to exchange
        data between a reader and an electronic tag attached to an object, for the purpose of
        identification.
        Shipping containers
        A shipping container is a container in relation to which traceability is controlled by a
        process specific to logistics systems.
        Unique Device Identifier ('UDI')
        The UDI is a series of numeric or alphanumeric characters that is created through a
        globally accepted device identification and coding standard. It allows the unambiguous
        identification of a specific device on the market. The UDI is comprised of the UDI-DI and
        the UDI-PI.
        The word 'Unique' does not imply serialisation of individual production units.
        UDI carrier
        The UDI carrier is the means of conveying the UDI by using AIDC and, if applicable,
        its HRI.
        UDI carriers include, inter alia, ID/linear bar code, 2D/Matrix bar code, RFID.
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ANNEX VI                                       DGB 2C                                            EN
 ---pagebreak--- 2.      General requirements
2.1.    The affixing of the UDI is an additional requirement – it does not replace any other
        marking or labelling requirements laid down in Annex I to this Regulation.
2.2.    The manufacturer shall assign and maintain unique UDIs for its devices.
2.3.    Only the manufacturer may place the UDI on the device or its packaging.
2.4.    Only coding standards provided by issuing entities designated by the Commission pursuant
        to Article 27(2) may be used.
3.      The UDI
3.1.    A UDI shall be assigned to the device itself or its packaging. Higher levels of packaging
        shall have their own UDI.
3.2.    Shipping containers shall be exempted from the requirement in Section 3.1. By way of
        example, a UDI shall not be required on a logistics unit; where a healthcare provider orders
        multiple devices using the UDI or model number of individual devices and the
        manufacturer places those devices in a container for shipping or to protect the individually
        packaged devices, the container (logistics unit) shall not be subject to UDI requirements.
3.3.    The UDI shall contain two parts: a UDI-DI and a UDI-PI.
3.4.    The UDI-DI shall be unique at each level of device packaging.
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ANNEX VI                                      DGB 2C                                            EN
 ---pagebreak--- 3.5.    If a lot number, serial number, software identification or expiry date appears on the label, it
        shall be part of the UDI-PI. If there is also a manufacturing date on the label, it does not
        need to be included in the UDI-PI. If there is only a manufacturing date on the label, this
        shall be used as the UDI-PI.
3.6.    Each component that is considered to be a device and is commercially available on its own
        shall be assigned a separate UDI unless the components are part of a configurable device
        that is marked with its own UDI.
3.7.    Systems and procedure packs as referred to in Article 22 shall be assigned and bear their
        own UDI.
3.8.    The manufacturer shall assign the UDI to a device following the relevant coding standard.
3.9.    A new UDI-DI shall be required whenever there is a change that could lead to
        misidentification of the device and/or ambiguity in its traceability; in particular any change
        of one of the following UDI database data elements shall require a new UDI-DI:
        (a)    name or trade name,
        (b)    device version or model,
        (c)    labelled as single use,
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ANNEX VI                                        DGB 2C                                            EN
 ---pagebreak---         (d)   packaged sterile,
        (e)   need for sterilization before use,
        (f)   quantity of devices provided in a package,
        (g)   critical warnings or contra-indications: e.g. containing latex or DEHP.
3.10.   Manufacturers that repackage and/or relabel devices, with their own label shall retain a
        record of the original device manufacturer's UDI.
4.      UDI carrier
4.1.    The UDI carrier (AIDC and HRI representation of the UDI) shall be placed on the label or
        on the device itself and on all higher levels of device packaging. Higher levels do not
        include shipping containers.
4.2.    In the event of there being significant space constraints on the unit of use packaging the
        UDI carrier may be placed on the next higher packaging level.
4.3.    For single-use devices of classes I and IIa packaged and labelled individually, the
        UDI carrier shall not be required to appear on the packaging but it shall appear on a higher
        level of packaging, e.g. a carton containing several individually packaged devices.
        However, when the healthcare provider is not expected to have access, in cases such as in
        home healthcare settings, to the higher level of device packaging, the UDI shall be placed
        on the packaging of the individual device.
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ANNEX VI                                       DGB 2C                                            EN
 ---pagebreak--- 4.4.    For devices exclusively intended for retail point of sale the UDI-PIs in AIDC shall not be
        required to appear on the point of sale packaging.
4.5.    When AIDC carriers other than the UDI carrier are part of the product labelling, the
        UDI carrier shall be readily identifiable.
4.6.    If linear bar codes are used, the UDI-DI and UDI-PI may be concatenated or
        non-concatenated in two or more bar codes. All parts and elements of the linear bar code
        shall be distinguishable and identifiable.
4.7.    If there are significant constraints limiting the use of both AIDC and HRI on the label, only
        the AIDC format shall be required to appear on the label. For devices intended to be used
        outside healthcare facilities such as devices for home care, the HRI shall however appear
        on the label even if this results in there being no space for the AIDC.
4.8.    The HRI format shall follow the rules of the UDI code-issuing entity.
4.9.    If the manufacturer is using RFID technology, a linear or 2D bar code in line with the
        standard provided by the issuing entities shall also be provided on the label.
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ANNEX VI                                         DGB 2C                                         EN
 ---pagebreak--- 4.10.   Devices that are reusable shall bear a UDI carrier on the device itself. The UDI carrier for
        reusable devices that require cleaning, disinfection, sterilisation or refurbishing between
        patient uses shall be permanent and readable after each process performed to make the
        device ready for the subsequent use throughout the intended lifetime of the device. The
        requirement of this Section shall not apply to devices in the following circumstances:
        (a)    any type of direct marking would interfere with the safety or performance of the
               device;
        (b)    the device cannot be directly marked because it is not technologically feasible.
4.11.   The UDI carrier shall be readable during normal use and throughout the intended lifetime
        of the device.
4.12.   If the UDI carrier is readily readable, or in the case of AIDC scannable, through the
        device's packaging, the placing of the UDI carrier on the packaging shall not be required.
4.13.   In the case of single finished devices made up of multiple parts that must be assembled
        before their first use it shall be sufficient to place the UDI carrier on only one part of each
        device.
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ANNEX VI                                          DGB 2C                                            EN
 ---pagebreak--- 4.14.   The UDI carrier shall be placed in a manner such that the AIDC can be accessed during
        normal operation or storage.
4.15.   Bar code carriers that include both a UDI-DI and a UDI-PI may also include essential data
        for the device to operate or other data.
5.      General principles of the UDI database
5.1.    The UDI database shall support the use of all core UDI database data elements referred to
        in Part B of this Annex.
5.2.    Manufacturers shall be responsible for the initial submission and updates of the identifying
        information and other device data elements in the UDI database.
5.3.    Appropriate methods/procedures for validation of the data provided shall be implemented.
5.4.    Manufacturers shall periodically verify the correctness of all of the data relevant to devices
        they have placed on the market, except for devices that are no longer available on the
        market.
5.5.    The presence of the device UDI-DI in the UDI database shall not be assumed to mean that
        the device is in conformity with this Regulation.
5.6.    The database shall allow for the linking of all the packaging levels of the device.
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ANNEX VI                                       DGB 2C                                            EN
 ---pagebreak--- 5.7.    The data for new UDI-DIs shall be available at the time the device is placed on the market.
5.8.    Manufacturers shall update the relevant UDI database record within 30 days of a change
        being made to an element, which does not require a new UDI-DI.
5.9.    Internationally-accepted standards for data submission and updates shall, wherever
        possible, be used by the UDI database.
5.10.   The user interface of the UDI database shall be available in all official languages of the
        Union. The use of free-text fields shall, however, be minimized in order to reduce
        translations.
5.11.   Data relating to devices that are no longer available on the market shall be retained in the
        UDI database.
6.      Rules for specific device types
6.1.    Implantable devices:
6.1.1.  Implantable devices shall, at their lowest level of packaging ('unit packs'), be identified, or
        marked using AIDC, with a UDI (UDI-DI + UDI-PI);
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ANNEX VI                                       DGB 2C                                             EN
 ---pagebreak--- 6.1.2.  The UDI-PI shall have at least the following characteristics:
        (a)  the serial number for active implantable devices,
        (b)  the serial number or lot number for other implantable devices.
6.1.3.  The UDI of the implantable device shall be identifiable prior to implantation.
6.2.    Reusable devices requiring cleaning, disinfection, sterilisation or refurbishing between
        uses
6.2.1.  The UDI of such devices shall be placed on the device and be readable after each
        procedure to make the device ready for the next use.
6.2.2.  The UDI-PI characteristics such as the lot or serial number shall be defined by the
        manufacturer.
6.3.    Systems and procedure packs as referred to in Article 22
6.3.1.  The natural or legal person referred to in Article 22 shall be responsible for identifying the
        system or procedure pack with a UDI including both UDI-DI and UDI-PI.
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ANNEX VI                                      DGB 2C                                              EN
 ---pagebreak--- 6.3.2.  Device contents of system or procedure packs shall bear a UDI carrier on their packaging
        or on the device itself.
        Exemptions:
        (a)   individual single-use disposable devices, the uses of which are generally known to
              the persons by whom they are intended to be used, which are contained within a
              system or procedure pack, and which are not intended for individual use outside the
              context of the system or procedure pack, shall not be required to bear their own
              UDI carrier;
        (b)   devices that are exempted from bearing a UDI carrier on the relevant level of
              packaging shall not be required to bear a UDI carrier when included within a system
              or procedure pack.
6.3.3.  Placement of the UDI carrier on systems or procedure packs
        (a)   The system or procedure pack UDI carrier shall as a general rule be affixed to the
              outside of the packaging.
        (b)   The UDI carrier shall be readable, or, in the case of AIDC, scannable, whether
              placed on the outside of the packaging of the system or procedure pack or inside
              transparent packaging.
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ANNEX VI                                      DGB 2C                                           EN
 ---pagebreak--- 6.4.    Configurable devices:
6.4.1.  A UDI shall be assigned to the configurable device in its entirety and shall be called the
        configurable device UDI.
6.4.2.  The configurable device UDI-DI shall be assigned to groups of configurations, not per
        configuration within the group. A group of configurations is defined as the collection of
        possible configurations for a given device as described in the technical documentation.
6.4.3.  A configurable device UDI-PI shall be assigned to each individual configurable device.
6.4.4.  The carrier of the configurable device UDI shall be placed on the assembly that is most
        unlikely to be exchanged during the lifetime of the system and shall be identified as the
        configurable device UDI.
6.4.5.  Each component that is considered a device and is commercially available on its own shall
        be assigned a separate UDI.
6.5.    Device Software
6.5.1.  UDI assignment Criteria
        The UDI shall be assigned at the system level of the software. Only software which is
        commercially available on its own and software which constitutes a device in itself, shall
        be subject to that requirement.
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ANNEX VI                                      DGB 2C                                             EN
 ---pagebreak---         The software identification shall be considered to be the manufacturing control mechanism
        and shall be displayed in the UDI-PI.
6.5.2.  A new UDI-DI shall be required whenever there is a modification that changes:
        (a)    the original performance;
        (b)    the safety or the intended use of the software;
        (c)    interpretation of data.
        Such modifications include new or modified algorithms, database structures, operating
        platform, architecture or new user interfaces or new channels for interoperability.
6.5.3.  Minor software revisions shall require a new UDI-PI and not a new UDI-DI.
        Minor software revisions are generally associated with bug fixes, usability enhancements
        that are not for safety purposes, security patches or operating efficiency.
        Minor software revisions shall be identified by a manufacturer-specific form of
        identification.
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ANNEX VI                                       DGB 2C                                        EN
 ---pagebreak--- 6.5.4.  UDI placement criteria for software
        (a)  where the software is delivered on a physical medium, e.g. CD or DVD, each
             packaging level shall bear the human readable and AIDC representation of the
             complete UDI. The UDI that is applied to the physical medium containing the
             software and its packaging shall be identical to the UDI assigned to the system level
             software;
        (b)  the UDI shall be provided on a readily accessible screen for the user in an
             easily-readable plain-text format, such as an 'about' file, or included on the start-up
             screen;
        (c)  software lacking a user interface such as middleware for image conversion, shall be
             capable of transmitting the UDI through an application programming interface (API);
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ANNEX VI                                     DGB 2C                                               EN
 ---pagebreak---         (d) only the human readable portion of the UDI shall be required in electronic displays
            of the software. The marking of UDI using AIDC shall not be required in the
            electronic displays, such as 'about' menu, splash screen etc.;
        (e) the human readable format of the UDI for the software shall include the Application
            Identifiers (AI) for the standard used by the issuing entities, so as to assist the user in
            identifying the UDI and determining which standard is being used to create the UDI.
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ANNEX VI                                     DGB 2C                                               EN
 ---pagebreak---                                               ANNEX VII
                      REQUIREMENTS TO BE MET BY NOTIFIED BODIES
1.      ORGANISATIONAL AND GENERAL REQUIREMENTS
1.1.    Legal status and organisational structure
1.1.1.  Each notified body shall be established under the national law of a Member State, or under
        the law of a third country with which the Union has concluded an agreement in this
        respect. Its legal personality and status shall be fully documented. Such documentation
        shall include information about ownership and the legal or natural persons exercising
        control over the notified body.
1.1.2.  If the notified body is a legal entity that is part of a larger organisation, the activities of that
        organisation as well as its organisational structure and governance, and the relationship
        with the notified body shall be clearly documented. In such cases, the requirements of
        Section 1.2 are applicable to both the notified body and the organisation to which it
        belongs.
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ANNEX VII                                        DGB 2C                                               EN
 ---pagebreak--- 1.1.3.  If a notified body wholly or partly owns legal entities established in a Member State or in a
        third country or is owned by another legal entity, the activities and responsibilities of those
        entities, as well as their legal and operational relationships with the notified body, shall be
        clearly defined and documented. Personnel of those entities performing conformity
        assessment activities under this Regulation shall be subject to the applicable requirements
        of this Regulation.
1.1.4.  The organisational structure, allocation of responsibilities, reporting lines and operation of
        the notified body shall be such that they ensure that there is confidence in the performance
        by the notified body and in the results of the conformity assessment activities it conducts.
1.1.5.  The notified body shall clearly document its organisational structure and the functions,
        responsibilities and authority of its top-level management and of other personnel who may
        have an influence upon the performance by the notified body and upon the results of its
        conformity assessment activities.
1.1.6.  The notified body shall identify the persons in top-level management that have overall
        authority and responsibility for each of the following:
        –      the provision of adequate resources for conformity assessment activities;
        –      the development of procedures and policies for the operation of the notified body;
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ANNEX VII                                       DGB 2C                                             EN
 ---pagebreak---         –      the supervision of implementation of the procedures, policies and quality
               management systems of the notified body;
        –     the supervision of the notified body's finances;
        –     the activities and decisions taken by the notified body, including contractual
              agreements;
        –     the delegation of authority to personnel and/or committees, where necessary, for the
              performance of defined activities;
        –     the interaction with the authority responsible for notified bodies and the obligations
              regarding communications with other competent authorities, the Commission and
              other notified bodies.
1.2.    Independence and impartiality
1.2.1.  The notified body shall be a third-party body that is independent of the manufacturer of the
        device in relation to which it performs conformity assessment activities. The notified body
        shall also be independent of any other economic operator having an interest in the device
        as well as of any competitors of the manufacturer. This does not preclude the notified body
        from carrying out conformity assessment activities for competing manufacturers.
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ANNEX VII                                      DGB 2C                                            EN
 ---pagebreak--- 1.2.2.  The notified body shall be organised and operated so as to safeguard the independence,
        objectivity and impartiality of its activities. The notified body shall document and
        implement a structure and procedures for safeguarding impartiality and for promoting and
        applying the principles of impartiality throughout its organisation, personnel and
        assessment activities. Such procedures shall provide for the identification, investigation
        and resolution of any case in which a conflict of interest may arise, including involvement
        in consultancy services in the field of devices prior to taking up employment with the
        notified body. The investigation, outcome and its resolution shall be documented.
1.2.3.  The notified body, its top-level management and the personnel responsible for carrying out
        the conformity assessment tasks shall not:
        (a)   be the designer, manufacturer, supplier, installer, purchaser, owner or maintainer of
              devices which they assess, nor the authorised representative of any of those parties.
              Such restriction shall not preclude the purchase and use of assessed devices that are
              necessary for the operations of the notified body and the conduct of the conformity
              assessment, or the use of such devices for personal purposes;
        (b)   be involved in the design, manufacture or construction, marketing, installation and
              use, or maintenance of the devices for which they are designated, nor represent the
              parties engaged in those activities;
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ANNEX VII                                       DGB 2C                                           EN
 ---pagebreak---         (c)    engage in any activity that may conflict with their independence of judgement or
               integrity in relation to conformity assessment activities for which they are
               designated;
        (d)    offer or provide any service which may jeopardise the confidence in their
               independence, impartiality or objectivity. In particular, they shall not offer or provide
               consultancy services to the manufacturer, its authorised representative, a supplier or a
               commercial competitor as regards the design, construction, marketing or
               maintenance of devices or processes under assessment, and
        (e)    be linked to any organisation which itself provides consultancy services as referred
               to in point (d). Such restriction does not preclude general training activities that are
               not client specific and that relate to regulation of devices or to related standards.
1.2.4.  Involvement in consultancy services in the field of devices prior to taking up employment
        with a notified body shall be fully documented at the time of employment and potential
        conflicts of interest shall be monitored and resolved in accordance with this Annex.
        Personnel who were formerly employed by a specific client or provided consultancy
        services in the field of devices to that specific client prior to taking up employment with a
        notified body, shall not be assigned for conformity assessment activities for that specific
        client or companies belonging to the same group for a period of three years.
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ANNEX VII                                        DGB 2C                                              EN
 ---pagebreak--- 1.2.5.  The impartiality of notified bodies, of their top level management and of the assessment
        personnel shall be guaranteed. The level of the remuneration of the top level management
        and assessment personnel of a notified body and subcontractors, involved in assessment
        activities shall not depend on the results of the assessments. Notified bodies shall make
        publicly available the declarations of interest of their top-level management.
1.2.6.  If a notified body is owned by a public entity or institution, independence and absence of
        any conflict of interest shall be ensured and documented between, on the one hand, the
        authority responsible for notified bodies and/or the competent authority and, on the other
        hand, the notified body.
1.2.7.  The notified body shall ensure and document that the activities of its subsidiaries or
        subcontractors, or of any associated body, including the activities of its owners do not
        affect its independence, impartiality or the objectivity of its conformity assessment
        activities.
1.2.8.  The notified body shall operate in accordance with a set of consistent, fair and reasonable
        terms and conditions, taking into account the interests of small and medium-sized
        enterprises as defined in Recommendation 2003/361/EC in relation to fees.
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ANNEX VII                                      DGB 2C                                            EN
 ---pagebreak--- 1.2.9.  The requirements laid down in this Section in no way preclude exchanges of technical
        information and regulatory guidance between a notified body and a manufacturer applying
        for conformity assessment.
1.3.    Confidentiality
1.3.1.  The notified body shall have documented procedures in place ensuring that its personnel,
        committees, subsidiaries, subcontractors, and any associated body or personnel of external
        bodies respect the confidentiality of the information which comes into its possession
        during the performance of conformity assessment activities, except when disclosure is
        required by law.
1.3.2.  The personnel of a notified body shall observe professional secrecy in carrying out their
        tasks under this Regulation or any provision of national law giving effect to it, except in
        relation to the authorities responsible for notified bodies, competent authorities for medical
        devices in the Member States or the Commission. Proprietary rights shall be protected. The
        notified body shall have documented procedures in place in respect of the requirements of
        this Section.
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ANNEX VII                                      DGB 2C                                            EN
 ---pagebreak--- 1.4.    Liability
1.4.1.  The notified body shall take out appropriate liability insurance for its conformity
        assessment activities, unless liability is assumed by the Member State in question in
        accordance with national law or that Member State is directly responsible for the
        conformity assessment.
1.4.2.  The scope and overall financial value of the liability insurance shall correspond to the level
        and geographic scope of activities of the notified body and be commensurate with the risk
        profile of the devices certified by the notified body. The liability insurance shall cover
        cases where the notified body may be obliged to withdraw, restrict or suspend certificates.
1.5.    Financial requirements
        The notified body shall have at its disposal the financial resources required to conduct its
        conformity assessment activities within its scope of designation and related business
        operations. It shall document and provide evidence of its financial capacity and its
        long-term economic viability, taking into account, where relevant, any specific
        circumstances during an initial start-up phase.
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ANNEX VII                                       DGB 2C                                             EN
 ---pagebreak--- 1.6.    Participation in coordination activities
1.6.1.  The notified body shall participate in, or ensure that its assessment personnel is informed
        of, any relevant standardisation activities and in the activities of the notified body
        coordination group referred to in Article 49 and that its assessment and decision-making
        personnel are informed of all relevant legislation, guidance and best practice documents
        adopted in the framework of this Regulation.
1.6.2.  The notified body shall take into consideration guidance and best practice documents.
2.      QUALITY MANAGEMENT REQUIREMENTS
2.1.    The notified body shall establish, document, implement, maintain and operate a quality
        management system that is appropriate to the nature, area and scale of its conformity
        assessment activities and is capable of supporting and demonstrating the consistent
        fulfilment of the requirements of this Regulation.
2.2.    The quality management system of the notified body shall address at least the following:
        –     management system structure and documentation, including policies and objectives
              for its activities;
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ANNEX VII                                      DGB 2C                                            EN
 ---pagebreak---         –      policies for assignment of activities and responsibilities to personnel;
        –      assessment and decision-making processes in accordance with the tasks,
               responsibilities and role of the notified body's personnel and top-level management;
        –      the planning, conduct, evaluation and, if necessary, adaptation of its conformity
               assessment procedures;
        –      control of documents;
        –      control of records;
        –      management reviews;
        –      internal audits;
        –      corrective and preventive actions;
        –      complaints and appeals; and
        –      continuous training.
        Where documents are used in various languages, the notified body shall ensure and control
        that they have the same content.
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ANNEX VII                                       DGB 2C                                           EN
 ---pagebreak--- 2.3.    The top-level management of the notified body shall ensure that the quality management
        system is fully understood, implemented and maintained throughout the notified body
        organisation including subsidiaries and subcontractors involved in conformity assessment
        activities pursuant to this Regulation.
2.4.    The notified body shall require all personnel to formally commit themselves by a signature
        or equivalent to comply with the procedures defined by the notified body. That
        commitment shall cover aspects relating to confidentiality and to independence from
        commercial and other interests, and any existing or prior association with clients. The
        personnel shall be required to complete written statements indicating their compliance with
        confidentiality, independence and impartiality principles.
3.      RESOURCE REQUIREMENTS
3.1.    General
3.1.1.  Notified bodies shall be capable of carrying out all the tasks falling to them under this
        Regulation with the highest degree of professional integrity and the requisite competence
        in the specific field, whether those tasks are carried out by notified bodies themselves or on
        their behalf and under their responsibility.
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ANNEX VII                                       DGB 2C                                            EN
 ---pagebreak---         In particular, notified bodies shall have the necessary personnel and possess or have access
        to all equipment, facilities and competence needed to perform properly the technical,
        scientific and administrative tasks entailed in the conformity assessment activities in
        relation to which they have been designated.
        Such requirement presupposes at all times and for each conformity assessment procedure
        and each type of devices in relation to which they have been designated, that the notified
        body has permanent availability of sufficient administrative, technical and scientific
        personnel who possess experience and knowledge relating to the relevant devices and the
        corresponding technologies. Such personnel shall be in sufficient numbers to ensure that
        the notified body in question can perform the conformity assessment tasks, including the
        assessment of the medical functionality, clinical evaluations and the performance and
        safety of devices, for which it has been designated, having regard to the requirements of
        this Regulation, in particular, those set out in Annex I.
        A notified body's cumulative competences shall be such as to enable it to assess the types
        of devices for which it is designated. The notified body shall have sufficient internal
        competence to critically evaluate assessments conducted by external expertise. Tasks
        which a notified body is precluded from subcontracting are set out in Section 4.1.
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ANNEX VII                                       DGB 2C                                          EN
 ---pagebreak---         Personnel involved in the management of the operation of a notified body's conformity
        assessment activities for devices shall have appropriate knowledge to set up and operate a
        system for the selection of assessment and verification staff, for verification of their
        competence, for authorisation and allocation of their tasks, for organisation of their initial
        and ongoing training and for the assignment of their duties and the monitoring of those
        staff, in order to ensure that personnel who carry out and perform assessment and
        verification operations are competent to fulfil the tasks required of them.
        The notified body shall identify at least one individual within its top-level management as
        having overall responsibility for all conformity assessment activities in relation to devices.
3.1.2.  The notified body shall ensure that personnel involved in conformity assessment activities
        maintain their qualification and expertise by implementing a system for exchange of
        experience and a continuous training and education programme.
3.1.3.  The notified body shall clearly document the extent and limits of duties and responsibilities
        and the level of authorisation of the personnel, including any subcontractors and external
        experts, involved in conformity assessment activities and inform those personnel
        accordingly.
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ANNEX VII                                      DGB 2C                                             EN
 ---pagebreak--- 3.2.    Qualification criteria in relation to personnel
3.2.1.  The Notified Body shall establish and document qualification criteria and procedures for
        selection and authorisation of persons involved in conformity assessment activities,
        including as regards knowledge, experience and other competence required, and the
        required initial and ongoing training. The qualification criteria shall address the various
        functions within the conformity assessment process, such as auditing, product evaluation
        or testing, technical documentation review and decision-making, as well as the devices,
        technologies and areas, such as biocompatibility, sterilisation, tissues and cells of human
        and animal origin and clinical evaluation, covered by the scope of designation.
3.2.2.  The qualification criteria referred to in Section 3.2.1 shall refer to the scope of a notified
        body's designation in accordance with the scope description used by the Member State for
        the notification referred to in Article 42(3), providing a sufficient level of detail for the
        required qualification within the subdivisions of the scope description.
        Specific qualification criteria shall be defined at least for the assessment of:
        –      the pre-clinical evaluation,
        –      clinical evaluation,
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ANNEX VII                                       DGB 2C                                               EN
 ---pagebreak---         –     tissues and cells of human and animal origin,
        –     functional safety,
        –     software,
        –     packaging,
        –     devices that incorporate as an integral part a medicinal product,
        –     devices that are composed of substances or of combinations of substances that are
              absorbed by or locally dispersed in the human body and
        –     the different types of sterilisation processes.
3.2.3.  The personnel responsible for establishing qualification criteria and for authorising other
        personnel to perform specific conformity assessment activities shall be employed by the
        notified body itself and shall not be external experts or subcontracted. They shall have
        proven knowledge and experience in all of the following:
        –     Union devices legislation and relevant guidance documents;
        –     the conformity assessment procedures provided for in this Regulation;
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ANNEX VII                                        DGB 2C                                          EN
 ---pagebreak---         –     a broad base of knowledge of device technologies and the design and manufacture of
              devices;
        –     the notified body's quality management system, related procedures and the required
              qualification criteria;
        –     training relevant to personnel involved in conformity assessment activities in relation
              to devices;
        –     adequate experience in conformity assessments under this Regulation or previously
              applicable law within a notified body.
3.2.4.  The notified body shall have permanent availability of personnel with relevant clinical
        expertise and where possible such personnel shall be employed by the notified body itself.
        Such personnel shall be integrated throughout the notified body's assessment and decision-
        making process in order to:
        –     identify when specialist input is required for the assessment of the clinical evaluation
              conducted by the manufacturer and identify appropriately qualified experts;
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ANNEX VII                                      DGB 2C                                            EN
 ---pagebreak---         – appropriately train external clinical experts in the relevant requirements of this
          Regulation, CS, guidance and harmonised standards and ensure that the external
          clinical experts are fully aware of the context and implications of their assessment
          and the advice they provide;
        – be able to review and scientifically challenge the clinical data contained within the
          clinical evaluation, and any associated clinical investigations, and appropriately
          guide external clinical experts in the assessment of the clinical evaluation presented
          by the manufacturer;
        – be able to scientifically evaluate and, if necessary, challenge the clinical evaluation
          presented, and the results of the external clinical experts' assessment of the
          manufacturer's clinical evaluation;
        – be able to ascertain the comparability and consistency of the assessments of clinical
          evaluations conducted by clinical experts;
        – be able to make an assessment of the manufacturer's clinical evaluation and a clinical
          judgement of the opinion provided by any external expert and make a
          recommendation to the notified body's decision maker; and
        – be able to draw up records and reports demonstrating that the relevant conformity
          assessment activities have been appropriately carried out.
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ANNEX VII                                  DGB 2C                                              EN
 ---pagebreak--- 3.2.5.  The personnel responsible for carrying out product-related reviews (product reviewers),
        such as technical documentation reviews or type examination, including aspects such as
        clinical evaluation, biological safety, sterilisation and software validation, shall have all of
        the following proven qualifications:
        –     successful completion of a university or a technical college degree or equivalent
              qualification in relevant studies, e.g. medicine, pharmacy, engineering or other
              relevant sciences;
        –     four years' professional experience in the field of healthcare products or related
              activities, such as in manufacturing, auditing or research, of which two years shall be
              in the design, manufacture, testing or use of the device or technology to be assessed
              or related to the scientific aspects to be assessed;
        –     knowledge of device legislation, including the general safety and performance
              requirements set out in Annex I;
        –     appropriate knowledge and experience of relevant harmonised standards, CS and
              guidance documents;
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ANNEX VII                                       DGB 2C                                             EN
 ---pagebreak---         –    appropriate knowledge and experience of risk management and related device
             standards and guidance documents;
        –    appropriate knowledge and experience of clinical evaluation;
        –    appropriate knowledge of the devices which they are assessing;
        –    appropriate knowledge and experience of the conformity assessment procedures laid
             down in Annexes IX to XI, in particular of the aspects of those procedures for which
             they are responsible, and adequate authorisation for carrying out those assessments;
        –    the ability to draw up records and reports demonstrating that the relevant conformity
             assessment activities have been appropriately carried out.
3.2.6.  The personnel responsible for carrying out audits of the manufacturer's quality
        management system (site auditors) shall have all of the following proven qualifications:
        –    successful completion of a university or a technical college degree or equivalent
             qualification in relevant studies, such as medicine, pharmacy, engineering or other
             relevant sciences;
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ANNEX VII                                     DGB 2C                                           EN
 ---pagebreak---         – four years' professional experience in the field of healthcare products or related
          activities, such as in manufacturing, auditing or research, of which two years shall be
          in the area of quality management;
        – appropriate knowledge of devices legislation as well as related harmonised standards,
          CS and guidance documents;
        – appropriate knowledge and experience of risk management and related device
          standards and guidance documents;
        – appropriate knowledge of quality management systems and related standards and
          guidance documents;
        – appropriate knowledge and experience of the conformity assessment procedures laid
          down in Annexes IX to XI, in particular of the aspects of those procedures for which
          they are responsible, and adequate authorisation for carrying out those audits;
        – training in auditing techniques enabling them to challenge quality management
          systems;
        – the ability to draw up records and reports demonstrating that the relevant conformity
          assessment activities have been appropriately carried out.
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ANNEX VII                                 DGB 2C                                             EN
 ---pagebreak--- 3.2.7.  The personnel with overall responsibility for final reviews and decision-making on
        certification shall be employed by the notified body itself and shall not be external experts
        or be subcontracted. Those personnel shall, as a group, have proven knowledge and
        comprehensive experience of all of the following:
        –      devices legislation and relevant guidance documents;
        –      the device conformity assessments relevant to this Regulation;
        –      the types of qualifications, experience and expertise relevant to device conformity
               assessment;
        –      a broad base of knowledge of device technologies, including sufficient experience of
               conformity assessment of devices being reviewed for certification, the device
               industry and the design and manufacture of devices;
        –      the notified body's quality management system, related procedures and the required
               qualifications for personnel involved;
        –      the ability to draw up records and reports demonstrating that the conformity
               assessment activities have been appropriately carried out.
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ANNEX VII                                       DGB 2C                                           EN
 ---pagebreak--- 3.3.    Documentation of qualification, training and authorisation of personnel
3.3.1.  The notified body shall have a procedure in place to fully document the qualification of
        each member of personnel involved in conformity assessment activities and the satisfaction
        of the qualification criteria referred to in Section 3.2. Where in exceptional circumstances
        the fulfilment of the qualification criteria set out in Section 3.2. cannot be fully
        demonstrated, the notified body shall justify to the authority responsible for notified bodies
        the authorisation of those members of personnel to carry out specific conformity
        assessment activities.
3.3.2.  For all of its personnel referred to in Sections 3.2.3 to 3.2.7, the notified body shall
        establish and maintain up to date:
        –     a matrix detailing the authorisations and responsibilities of the personnel in respect
              of conformity assessment activities; and
        –     records attesting to the required knowledge and experience for the conformity
              assessment activity for which they are authorised. The records shall contain a
              rationale for defining the scope of the responsibilities for each of the assessment
              personnel and records of the conformity assessment activities carried out by each of
              them.
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ANNEX VII                                        DGB 2C                                           EN
 ---pagebreak--- 3.4.    Subcontractors and external experts
3.4.1.  Notified bodies may, without prejudice to Section 3.2, subcontract certain clearly defined
        component parts of a conformity assessment activity.
        The subcontracting of the auditing of quality management systems or of product related
        reviews as a whole shall not be permitted; nevertheless parts of those activities may be
        conducted by subcontractors and external auditors and experts working on behalf of the
        notified body. The notified body in question shall retain full responsibility for being able to
        produce appropriate evidence of the competence of subcontractors and experts to fulfil
        their specific tasks, for making a decision based on a subcontractor's assessment and for
        the work conducted by subcontractors and experts on its behalf.
        The following activities may not be subcontracted by notified bodies:
        –      review of the qualifications and monitoring of the performance of external experts;
        –      auditing and certification activities where the subcontracting in question is to
               auditing or certification organisations;
        –      allocation of work to external experts for specific conformity assessment activities;
               and
        –      final review and decision making functions.
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ANNEX VII                                       DGB 2C                                            EN
 ---pagebreak--- 3.4.2.  Where a notified body subcontracts certain conformity assessment activities either to an
        organisation or an individual, it shall have a policy describing the conditions under which
        subcontracting may take place, and shall ensure that:
        –      the subcontractor meets the relevant requirements of this Annex;
        –      subcontractors and external experts do not further subcontract work to organisations
               or personnel; and
        –      the natural or legal person that applied for conformity assessment has been informed
               of the requirements referred to in the first and second indent.
        Any subcontracting or consultation of external personnel shall be properly documented,
        shall not involve any intermediaries and shall be subject to a written agreement covering,
        among other things, confidentiality and conflicts of interest. The notified body in question
        shall take full responsibility for the tasks performed by subcontractors.
3.4.3.  Where subcontractors or external experts are used in the context of a conformity
        assessment, in particular regarding novel, invasive and implantable devices or
        technologies, the notified body in question shall have internal competence in each product
        area for which it is designated that is adequate for the purpose of leading the overall
        conformity assessment, verifying the appropriateness and validity of expert opinions and
        making decisions on certification.
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ANNEX VII                                        DGB 2C                                         EN
 ---pagebreak--- 3.5.    Monitoring of competences, training and exchange of experience
3.5.1.  The notified body shall establish procedures for the initial evaluation and on-going
        monitoring of the competence, conformity assessment activities and performance of all
        internal and external personnel, and subcontractors, involved in conformity assessment
        activities.
3.5.2.  Notified bodies shall review at regular intervals, the competence of their personnel,
        identify training needs and draw up a training plan to maintain the required level of
        qualification and knowledge of individual personnel. That review shall at a minimum,
        verify that personnel:
        –     are aware of Union and national law in force on devices, relevant harmonised
               standards, CS, guidance documents and the results of the coordination activities
               referred to in Section 1.6; and
        –     take part in the internal exchange of experience and the continuous training and
              education programme referred to in Section 3.1.2.
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ANNEX VII                                      DGB 2C                                           EN
 ---pagebreak--- 4.      PROCESS REQUIREMENTS
4.1.    General
        The notified body shall have in place documented processes and sufficiently detailed
        procedures for the conduct of each conformity assessment activity for which it is
        designated, comprising the individual steps from pre-application activities up to decision
        making and surveillance and taking into account, when necessary, the respective
        specificities of the devices.
        The requirements laid down in Sections 4.3, 4.4, 4.7 and 4.8 shall be fulfilled as part of the
        internal activities of notified bodies and shall not be subcontracted.
4.2.    Notified body quotations and pre-application activities
        The notified body shall:
        (a)   publish a publicly available description of the application procedure by which
              manufacturers can obtain certification from it. That description shall include which
              languages are acceptable for submission of documentation and for any related
              correspondence;
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ANNEX VII                                       DGB 2C                                           EN
 ---pagebreak---         (b) have documented procedures relating to, and documented details about, fees charged
            for specific conformity assessment activities and any other financial conditions
            relating to notified bodies' assessment activities for devices;
        (c) have documented procedures in relation to advertising of their conformity
            assessment services. Those procedures shall ensure that advertising or promotional
            activities in no way imply or are capable of leading to an inference that their
            conformity assessment will offer manufacturers earlier market access or be quicker,
            easier or less stringent than that of other notified bodies;
        (d) have documented procedures requiring the review of pre-application information,
            including the preliminary verification that the product is covered by this Regulation
            and its classification, prior to issuing any quotation to the manufacturer relating to a
            specific conformity assessment; and
        (e) ensure that all contracts relating to the conformity assessment activities covered by
            this Regulation are concluded directly between the manufacturer and the notified
            body and not with any other organisation.
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ANNEX VII                                      DGB 2C                                           EN
 ---pagebreak--- 4.3.    Application review and contract
        The notified body shall require a formal application signed by a manufacturer or an
        authorised representative containing all of the information and the manufacturer's
        declarations required by the relevant conformity assessment as referred to in Annexes IX
        to XI.
        The contract between a notified body and a manufacturer shall take the form of a written
        agreement signed by both parties. It shall be kept by the notified body. This contract shall
        have clear terms and conditions and contain obligations that enable the notified body to act
        as required under this Regulation, including an obligation on the manufacturer to inform
        the notified body of vigilance reports, the right of the notified body to suspend, restrict or
        withdraw certificates issued and the duty of the notified body to fulfil its information
        obligations.
        The notified body shall have documented procedures to review applications, addressing:
        (a)    the completeness of those applications with respect to the requirements of the
               relevant conformity assessment procedure, as referred to in the corresponding
               Annex, under which approval has been sought,
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ANNEX VII                                     DGB 2C                                               EN
 ---pagebreak---         (b)   the verification of the qualification of products covered by those applications as
              devices and their respective classifications,
        (c)   whether the conformity assessment procedures chosen by the applicant are applicable
              to the device in question under this Regulation,
        (d)   the ability of the notified body to assess the application based on its designation, and
        (e)   the availability of sufficient and appropriate resources.
        The outcome of each review of an application shall be documented. Refusals or
        withdrawals of applications shall be notified to the electronic system referred to in
        Article 57 and shall be accessible to other notified bodies.
4.4.    Allocation of resources
        The notified body shall have documented procedures to ensure that all conformity
        assessment activities are conducted by appropriately authorised and qualified personnel
        who are sufficiently experienced in the evaluation of the devices, systems and processes
        and related documentation that are subject to conformity assessment.
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ANNEX VII                                       DGB 2C                                            EN
 ---pagebreak---         For each application, the notified body shall determine the resources needed and identify
        one individual responsible for ensuring that the assessment of that application is conducted
        in accordance with the relevant procedures and for ensuring that the appropriate resources
        including personnel are utilised for each of the tasks of the assessment. The allocation of
        tasks required to be carried out as part of the conformity assessment and any changes
        subsequently made to this allocation shall be documented.
4.5.    Conformity assessment activities
4.5.1.  General
        The notified body and its personnel shall carry out the conformity assessment activities
        with the highest degree of professional integrity and the requisite technical and scientific
        competence in the specific fields.
        The notified body shall have expertise, facilities and documented procedures that are
        sufficient to effectively conduct the conformity assessment activities for which the notified
        body in question is designated, taking account of the relevant requirements set out in
        Annexes IX to XI, and in particular all of the following requirements:
        –     appropriately plan the conduct of each individual project,
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ANNEX VII                                      DGB 2C                                            EN
 ---pagebreak---         – ensure that the composition of the assessment teams is such that there is sufficient
          experience in relation to the technology concerned, and that there is continuous
          objectivity and independence, and to provide for rotation of the members of the
          assessment team at appropriate intervals,
        – specify the rationale for fixing time limits for completion of conformity assessment
          activities,
        – assess the manufacturer's technical documentation and the solutions adopted to meet
          the requirements laid down in Annex I,
        – review the manufacturer's procedures and documentation relating to the evaluation of
          pre-clinical aspects,
        – review the manufacturer's procedures and documentation relating to clinical
          evaluation,
        – address the interface between the manufacturer's risk management process and its
          appraisal and analysis of the pre-clinical and clinical evaluation and to evaluate their
          relevance for the demonstration of conformity with the relevant requirements in
          Annex I,
        – carry out the specific procedures referred to in Sections 5.2 to 5.4 of Annex IX,
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ANNEX VII                                   DGB 2C                                            EN
 ---pagebreak---         –     in the case of class IIa or class IIb devices, assess the technical documentation of
              devices selected on a representative basis,
        –     plan and periodically carry out appropriate surveillance audits and assessments, carry
              out or request certain tests to verify the proper functioning of the quality
              management system and to perform unannounced on site audits,
        –     relating to the sampling of devices, verify that the manufactured device is in
              conformity with the technical documentation; such requirements shall define the
              relevant sampling criteria and testing procedure prior to sampling,
        –     evaluate and verify a manufacturer's compliance with relevant Annexes.
        The notified body shall, where relevant, take into consideration available CS, guidance and
        best practice documents and harmonised standards, even if the manufacturer does not
        claim to be in compliance.
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ANNEX VII                                        DGB 2C                                          EN
 ---pagebreak--- 4.5.2.  Quality management system auditing
        (a)   As part of the assessment of the quality management system, a notified body shall
              prior to an audit and in accordance with its documented procedures:
             –       assess the documentation submitted in accordance with the relevant conformity
                     assessment Annex, and draw up an audit programme which clearly identifies
                     the number and sequence of activities required to demonstrate complete
                     coverage of a manufacturer's quality management system and to determine
                     whether it meets the requirements of this Regulation,
              –      identify links between, and allocation of responsibilities among, the various
                     manufacturing sites, and identify relevant suppliers and/or subcontractors of
                     the manufacturer, and consider the need to specifically audit any of those
                     suppliers or subcontractors or both,
              –      clearly define, for each audit identified in the audit programme, the objectives,
                     criteria and scope of the audit, and draw up an audit plan that adequately
                     addresses and takes account of the specific requirements for the devices,
                     technologies and processes involved,
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ANNEX VII                                       DGB 2C                                            EN
 ---pagebreak---             –     draw up and keep up to date, for class IIa and class IIb devices, a sampling plan
                  for the assessment of technical documentation as referred to in Annexes II and
                  III covering the range of such devices covered by the manufacturer's
                  application. That plan shall ensure that all devices covered by the certificate are
                  sampled over the period of validity of the certificate, and
            –     select and assign appropriately qualified and authorised personnel for
                  conducting the individual audits. The respective roles, responsibilities and
                  authorities of the team members shall be clearly defined and documented.
        (b) Based on the audit programme it has drawn up, the notified body shall, in accordance
            with its documented procedures:
            –     audit the manufacturer's quality management system, in order to verify that the
                  quality management system ensures that the devices covered conform to the
                  relevant provisions of this Regulation which apply to devices at every stage,
                  from design through final quality control to ongoing surveillance, and shall
                  determine whether the requirements of this Regulation are met,
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ANNEX VII                                   DGB 2C                                              EN
 ---pagebreak---           – based on relevant technical documentation and in order to determine whether
            the manufacturer meets the requirements referred to in the relevant conformity
            assessment Annex, review and audit the manufacturer's processes and
            subsystems, in particular for:
            –     design and development,
            –     production and process controls,
            –     product documentation,
            –     purchasing controls including verification of purchased devices,
            –     corrective and preventive actions, including for post-market surveillance,
                  and
            –     PMCF,
            and review and audit requirements and provisions adopted by the
            manufacturer, including those in relation to fulfilling the general safety and
            performance requirements set out in Annex I.
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ANNEX VII                             DGB 2C                                             EN
 ---pagebreak---             The documentation shall be sampled in such a manner as to reflect the risks
            associated with the intended use of the device, the complexity of the
            manufacturing technologies, the range and classes of devices produced and any
            available post-market surveillance information,
          – if not already covered by the audit programme, audit the control of processes
            on the premises of the manufacturer's suppliers, when the conformity of
            finished devices is significantly influenced by the activity of suppliers and, in
            particular when the manufacturer cannot demonstrate sufficient control over its
            suppliers,
          – conduct assessments of the technical documentation based on its sampling plan
            and taking account of Sections 4.5.4. and 4.5.5. for pre-clinical and clinical
            evaluations, and
          – the notified body shall ensure that audit findings are appropriately and
            consistently classified in accordance with the requirements of this Regulation
            and with relevant standards, or with best practice documents developed or
            adopted by the MDCG.
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ANNEX VII                              DGB 2C                                            EN
 ---pagebreak--- 4.5.3.  Product verification
        Assessment of the technical documentation
        For assessment of the technical documentation conducted in accordance with Chapter II of
        Annex IX, notified bodies shall have sufficient expertise, facilities and documented
        procedures for:
        –     the allocation of appropriately qualified and authorised personnel for the examination
              of individual aspects such as use of the device, biocompatibility, clinical evaluation,
              risk management, and sterilisation, and
        –     the assessment of conformity of the design with this Regulation. and for taking
              account of Sections 4.5.4. to 4.5.6. That assessment shall include examination of the
              implementation by manufacturers of incoming, in-process and final checks and the
              results thereof. If further tests or other evidence is required for the assessment of
              conformity with the requirements of this Regulation, the notified body in question
              shall carry out adequate physical or laboratory tests in relation to the device or
              request the manufacturer to carry out such tests.
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ANNEX VII                                        DGB 2C                                            EN
 ---pagebreak---         Type-examinations
        The notified body shall have documented procedures, sufficient expertise and facilities for
        the type-examination of devices in accordance with Annex X including the capacity to:
        –     examine and assess the technical documentation taking account of Sections 4.5.4.
              to 4.5.6., and verify that the type has been manufactured in conformity with that
              documentation;
        –     establish a test plan identifying all relevant and critical parameters which need to be
              tested by the notified body or under its responsibility;
        –     document its rationale for the selection of those parameters;
        –     carry out the appropriate examinations and tests in order to verify that the solutions
              adopted by the manufacturer meet the general safety and performance requirements
              set out in Annex I. Such examinations and tests shall include all tests necessary to
              verify that the manufacturer has in fact applied the relevant standards it has opted to
              use;
        –     agree with the applicant as to where the necessary tests will be performed if they are
              not to be carried out directly by the notified body; and
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ANNEX VII                                       DGB 2C                                            EN
 ---pagebreak---         –     assume full responsibility for test results. Test reports submitted by the manufacturer
              shall only be taken into account if they have been issued by conformity assessment
              bodies which are competent and independent of the manufacturer.
        Verification by examination and testing of every product
        The notified body shall:
        (a)   have documented procedures, sufficient expertise and facilities for the verification by
              examination and testing of every product in accordance with Part B of Annex XI;
        (b)   establish a test plan identifying all relevant and critical parameters which need to be
              tested by the notified body or under its responsibility in order to:
              –     verify, for class IIb devices, the conformity of the device with the type
                    described in the EU type-examination certificate and with the requirements of
                    this Regulation which apply to those devices,
              –     confirm, for class IIa devices, the conformity with the technical documentation
                    referred to in Annexes II and III and with the requirements of this Regulation
                    which apply to those devices;
        (c)   document its rationale for the selection of the parameters referred to in point (b);
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ANNEX VII                                       DGB 2C                                            EN
 ---pagebreak---         (d)   have documented procedures to carry out the appropriate assessments and tests in
              order to verify the conformity of the device with the requirements of this Regulation
              by examining and testing every product as specified in Section 15 of Annex XI;
        (e)   have documented procedures providing for the reaching of an agreement with the
              applicant concerning when and where necessary tests that are not to be carried out by
              the notified body itself are to be performed; and
        (f)   assume full responsibility for test results in accordance with documented procedures;
              test reports submitted by the manufacturer shall only be taken into account if they
              have been issued by conformity assessment bodies which are competent and
              independent of the manufacturer.
4.5.4.  Pre-clinical evaluation assessment
        The notified body shall have documented procedures in place for the review of the
        manufacturer's procedures and documentation relating to the evaluation of pre-clinical
        aspects. The notified body shall examine, validate and verify that the manufacturer's
        procedures and documentation adequately address:
        (a)   the planning, conduct, assessment, reporting and, where appropriate, updating of the
              pre-clinical evaluation, in particular of
              –      the scientific pre-clinical literature search, and
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ANNEX VII                                        DGB 2C                                         EN
 ---pagebreak---                –      the pre-clinical testing, for example laboratory testing, simulated use testing,
                      computer modelling, the use of animal models,
        (b)    the nature and duration of body contact and the specific associated biological risks,
        (c)    the interface with the risk management process, and
        (d)    the appraisal and analysis of the available pre-clinical data and its relevance with
               regard to demonstrating conformity with the relevant requirements in Annex I.
        The notified body's assessment of pre-clinical evaluation procedures and documentation
        shall address the results of literature searches and all validation, verification and testing
        performed and conclusions drawn, and shall typically include considering the use of
        alternative materials and substances and take account of the packaging, stability, including
        shelf life, of the finished device. Where no new testing has been undertaken by a
        manufacturer or where there are deviations from procedures, the notified body in question
        shall critically examine the justification presented by the manufacturer.
4.5.5.  Clinical evaluation assessment
        The notified body shall have documented procedures in place relating to the assessment of
        a manufacturer's procedures and documentation relating to clinical evaluation both for
        initial conformity assessment and on an ongoing basis. The notified body shall examine,
        validate and verify that manufacturers' procedures and documentation adequately address:
        –      the planning, conduct, assessment, reporting and updating of the clinical evaluation
               as referred to in Annex XIV,
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ANNEX VII                                         DGB 2C                                            EN
 ---pagebreak---         –     post-market surveillance and PMCF,
        –     the interface with the risk management process,
        –     the appraisal and analysis of the available data and its relevance with regard to
              demonstrating conformity with the relevant requirements in Annex I, and
        –     the conclusions drawn with regard to the clinical evidence and drawing up of the
              clinical evaluation report.
        These procedures referred to in the first paragraph shall take into consideration available
        CS, guidance and best practice documents.
        The notified body's assessment of clinical evaluations as referred to in Annex XIV shall
        cover:
        –     the intended use specified by the manufacturer and claims for the device defined by
              it,
        –     the planning of the clinical evaluation,
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ANNEX VII                                      DGB 2C                                            EN
 ---pagebreak---         –      the methodology for the literature search,
        –      relevant documentation from the literature search,
        –      the clinical investigation,
        –      validity of equivalence claimed in relation to other devices, the demonstration of
               equivalence, the suitability and conclusions data from equivalent and similar devices,
        –      post-market surveillance and PMCF,
        –      the clinical evaluation report, and
        –      justifications in relation to non-performance of clinical investigations or PMCF.
        In relation to clinical data from clinical investigations included within the clinical
        evaluation, the notified body in question shall ensure that the conclusions drawn by the
        manufacturer are valid in the light of the approved clinical investigation plan.
        The notified body shall ensure that the clinical evaluation adequately addresses the relevant
        safety and performance requirements provided for in Annex I, that it is appropriately
        aligned with the risk management requirements, that it is conducted in accordance with
        Annex XIV and that it is appropriately reflected in the information provided relating to the
        device.
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ANNEX VII                                        DGB 2C                                          EN
 ---pagebreak--- 4.5.6.  Specific Procedures
        The notified body shall have documented procedures, sufficient expertise and facilities for
        the procedures referred to in Sections 5 and 6 of Annex IX, Section 6 of Annex X and
        Section 16 of Annex XI, for which they are designated.
        In the case of devices manufactured utilising tissues or cells of animal origin or their
        derivatives, such as from TSE susceptible species, as referred to in
        Regulation (EU) No 722/2012, the notified body shall have documented procedures in
        place that fulfil the requirements laid down in that Regulation, including for the
        preparation of a summary evaluation report for the relevant competent authority.
4.6.    Reporting
        The notified body shall:
        –     ensure that all steps of the conformity assessment are documented so that the
              conclusions of the assessment are clear and demonstrate compliance with the
              requirements of this Regulation and can represent objective evidence of such
              compliance to persons that are not themselves involved in the assessment, for
              example personnel in designating authorities,
        –     ensure that records that are sufficient to provide a discernible audit trail are available
              for quality management system audits,
        –     clearly document the conclusions of its assessment of clinical evaluation in a clinical
              evaluation assessment report, and
        –     for each specific project, provide a detailed report which shall be based on a standard
              format containing a minimum set of elements determined by the MDCG.
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ANNEX VII                                       DGB 2C                                              EN
 ---pagebreak---         The report of the notified body shall:
        –     clearly document the outcome of its assessment and draw clear conclusions from the
              verification of the manufacturer's conformity with the requirements of this
              Regulation,
        –     make a recommendation for a final review and for a final decision to be taken by the
              notified body; this recommendation shall be signed off by the member of personnel
              responsible in the notified body, and
        –     be provided to the manufacturer in question.
4.7.    Final review
        The notified body shall prior to making a final decision:
        –     ensure that the personnel assigned for the final review and decision-making on
              specific projects are appropriately authorised and are different from the personnel
              who have conducted the assessments,
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ANNEX VII                                      DGB 2C                                           EN
 ---pagebreak---         –     verify that the report or reports and supporting documentation needed for decision
              making, including concerning resolution of non-conformities noted during
              assessment, are complete and sufficient with respect to the scope of the application,
              and
        –     verify whether there are any unresolved non-conformities preventing issuance of a
              certificate.
4.8.    Decisions and Certifications
        The notified body shall have documented procedures for decision-making including as
        regards the allocation of responsibilities for the issuance, suspension, restriction and
        withdrawal of certificates. Those procedures shall include the notification requirements
        laid down in Chapter V of this Regulation. The procedures shall allow the notified body in
        question to:
        –     decide, based on the assessment documentation and additional information available,
              whether the requirements of this Regulation are fulfilled,
        –     decide, based on the results of its assessment of the clinical evaluation and risk
              management, whether the post-market surveillance plan, including the PMCF plan, is
              adequate,
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ANNEX VII                                       DGB 2C                                           EN
 ---pagebreak---         – decide on specific milestones for further review by the notified body of the up to date
          clinical evaluation,
        – decide whether specific conditions or provisions need to be defined for the
          certification,
        – decide, based on the novelty, risk classification, clinical evaluation and conclusions
          from the risk analysis of the device, on a period of certification not exceeding
          five years,
        – clearly document decision making and approval steps including approval by
          signature of the members of personnel responsible,
        – clearly document responsibilities and mechanisms for communication of decisions,
          in particular, where the final signatory of a certificate differs from the decision maker
          or decision makers or does not fulfil the requirements laid down in Section 3.2.7,
        – issue a certificate or certificates in accordance with the minimum requirements laid
          down in Annex XII for a period of validity not exceeding five years and shall
          indicate whether there are specific conditions or limitations associated with the
          certification,
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ANNEX VII                                    DGB 2C                                            EN
 ---pagebreak---         –     issue a certificate or certificates for the applicant alone and shall not issue certificates
              covering multiple entities, and
        –     ensure that the manufacturer is notified of the outcome of the assessment and the
              resultant decision and that they are entered into the electronic system referred to in
              Article 57.
4.9.    Changes and modifications
        The notified body shall have documented procedures and contractual arrangements with
        manufacturers in place relating to the manufacturers' information obligations and the
        assessment of changes to:
        –     the approved quality management system or systems or to the product-range covered,
        –     the approved design of a device,
        –     the intended use of or claims made for the device,
        –     the approved type of a device, and
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ANNEX VII                                        DGB 2C                                              EN
 ---pagebreak---         –     any substance incorporated in or utilised for the manufacturing of a device and being
              subject to the specific procedures in accordance with Section 4.5.6.
        The procedures and contractual arrangements referred to in the first paragraph shall include
        measures for checking the significance of the changes referred to in the first paragraph.
        In accordance with its documented procedures, the notified body in question shall:
        –     ensure that manufacturers submit for prior approval plans for changes as referred to
              in the first paragraph and relevant information relating to such changes,
        –     assess the changes proposed and verify whether, after these changes, the quality
              management system, or the design of a device or type of a device, still meets the
              requirements of this Regulation, and
        –     notify the manufacturer of its decision and provide a report or as applicable a
              supplementary report, which shall contain the justified conclusions of its assessment.
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ANNEX VII                                      DGB 2C                                           EN
 ---pagebreak--- 4.10.   Surveillance activities and post-certification monitoring
        The notified body shall have documented procedures:
        –    defining how and when surveillance activities of manufacturers are to be conducted.
             Those procedures shall include arrangements for unannounced on-site audits of
             manufacturers and, where applicable, subcontractors and suppliers carrying out
             product tests and the monitoring of compliance with any conditions binding
             manufacturers and associated with certification decisions, such as updates to clinical
             data at defined intervals,
        –    for screening relevant sources of scientific and clinical data and post-market
             information relating to the scope of their designation. Such information shall be
             taken into account in the planning and conduct of surveillance activities, and
        –    to review vigilance data to which they have access under Article 92(2) in order to
             estimate its impact, if any, on the validity of existing certificates. The results of the
             evaluation and any decisions taken shall be thoroughly documented.
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ANNEX VII                                      DGB 2C                                               EN
 ---pagebreak---         The notified body in question shall, upon receipt of information about vigilance cases from
        a manufacturer or competent authorities, decide which of the following options to apply:
        –    not to take action on the basis that the vigilance case is clearly not related to the
             certification granted,
        –    observe the manufacturer's and competent authority's activities and the results of the
             manufacturer's investigation so as to determine whether the certification granted is at
             risk or whether adequate corrective action has been taken,
        –    perform extraordinary surveillance measures, such as document reviews, short-notice
             or unannounced audits and product testing, where it is likely that the certification
             granted is at risk,
        –    increase the frequency of surveillance audits,
        –    review specific products or processes on the occasion of the next audit of the
             manufacturer, or
        –    take any other relevant measure.
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ANNEX VII                                     DGB 2C                                               EN
 ---pagebreak---         In relation to surveillance audits of manufacturers, the notified body shall have
        documented procedures to:
        –      conduct surveillance audits of the manufacturer on at least an annual basis which
               shall be planned and conducted in line with the relevant requirements in Section 4.5,
        –      ensure adequate assessment of the manufacturer's documentation on, and application
               of the provisions on, vigilance, the post-market surveillance, and PMCF,
        –      sample and test devices and technical documentation, during audits, according to pre-
               defined sampling criteria and testing procedures to ensure that the manufacturer
               continuously applies the approved quality management system,
        –      ensure that the manufacturer complies with the documentation and information
               obligations laid down in the relevant Annexes and that its procedures take into
               account best practices in the implementation of quality management systems,
        –      ensure that the manufacturer does not use quality management system or device
               approvals in a misleading manner,
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ANNEX VII                                       DGB 2C                                          EN
 ---pagebreak---         –    gather sufficient information to determine if the quality management system
             continues to comply with the requirements of this Regulation,
        –    ask the manufacturer, if non-conformities are detected, for corrections, corrective
             actions and, where applicable, preventive actions, and
        –    where necessary, impose specific restrictions on the relevant certificate or suspend or
             withdraw it.
        The notified body shall, if listed as part of the conditions for certification:
        –    conduct an in-depth review of the clinical evaluation as most recently updated by the
             manufacturer based on the manufacturer's post-market surveillance, on its PMCF and
             on clinical literature relevant to the condition being treated with the device or on
             clinical literature relevant to similar devices,
        –    clearly document the outcome of the in-depth review and address any specific
             concerns to the manufacturer or impose any specific conditions on it, and
        –    ensure that the clinical evaluation as most recently updated, is appropriately reflected
             in the instructions for use and, where applicable, the summary of safety and
             performance.
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ANNEX VII                                       DGB 2C                                           EN
 ---pagebreak--- 4.11.   Re-certification
        The notified body shall have documented procedures in place relating to the re-certification
        reviews and the renewal of certificates. Re-certification of approved quality management
        systems or EU technical documentation assessment certificates or EU type-examination
        certificates shall occur at least every five years.
        The notified body shall have documented procedures relating to renewals of EU technical
        documentation assessment certificates and EU type-examination certificates and those
        procedures shall require the manufacturer in question to submit a summary of changes and
        scientific findings for the device, including:
        (a)    all changes to the originally approved device, including changes not yet notified,
        (b)    experience gained from post-market surveillance,
        (c)    experience from risk management,
        (d)    experience from updating the proof of compliance with the general safety and
               performance requirements set out in Annex I,
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ANNEX VII                                        DGB 2C                                         EN
 ---pagebreak---         (e) experience from reviews of the clinical evaluation, including the results of any
            clinical investigations and PMCF,
        (f) changes to the requirements, to components of the device or to the scientific or
            regulatory environment,
        (g) changes to applied or new harmonised standards, CS or equivalent documents, and
        (h) changes in medical, scientific and technical knowledge, such as:
            –     new treatments,
            –     changes in test methods,
            –     new scientific findings on materials and components, including findings on
                  their biocompatibility,
            –     experience from studies on comparable devices,
            –     data from registers and registries,
            –     experience from clinical investigations with comparable devices.
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ANNEX VII                                   DGB 2C                                           EN
 ---pagebreak---         The notified body shall have documented procedures to assess the information referred to
        in the second paragraph and shall pay particular attention to clinical data from post-market
        surveillance and PMCF activities undertaken since the previous certification or re-
        certification, including appropriate updates to manufacturers' clinical evaluation reports.
        For decision on re-certification the notified body in question shall use the same methods
        and principles as for the initial certification decision. If necessary, separate forms shall be
        established for re-certification taking into account the steps taken for certification such as
        application and application review.
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ANNEX VII                                        DGB 2C                                             EN
 ---pagebreak---                                            ANNEX VIII
                                  CLASSIFICATION RULES
                                           Chapter I
                     Definitions specific to classification rules
1.      DURATION OF USE
1.1.    'Transient' means normally intended for continuous use for less than 60 minutes.
1.2.    'Short term' means normally intended for continuous use for between 60 minutes and
        30 days.
1.3.    'Long term' means normally intended for continuous use for more than 30 days.
2.      INVASIVE AND ACTIVE DEVICES
2.1.    'Body orifice' means any natural opening in the body, as well as the external surface of the
        eyeball, or any permanent artificial opening, such as a stoma.
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ANNEX VIII                                    DGB 2C                                            EN
 ---pagebreak--- 2.2.    'Surgically invasive device' means:
        (a)    an invasive device which penetrates inside the body through the surface of the body,
               including through mucous membranes of body orifices with the aid or in the context
               of a surgical operation; and
        (b)    a device which produces penetration other than through a body orifice.
2.3.    'Reusable surgical instrument' means an instrument intended for surgical use in cutting,
        drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures,
        without a connection to an active device and which is intended by the manufacturer to be
        reused after appropriate procedures such as cleaning, disinfection and sterilisation have
        been carried out.
2.4.    'Active therapeutic device' means any active device used, whether alone or in combination
        with other devices, to support, modify, replace or restore biological functions or structures
        with a view to treatment or alleviation of an illness, injury or disability.
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ANNEX VIII                                     DGB 2C                                            EN
 ---pagebreak--- 2.5.    'Active device intended for diagnosis and monitoring' means any active device used,
        whether alone or in combination with other devices, to supply information for detecting,
        diagnosing, monitoring or treating physiological conditions, states of health, illnesses or
        congenital deformities.
2.6.    'Central circulatory system' means the following blood vessels: arteriae pulmonales, aorta
        ascendens, arcus aortae, aorta descendens to the bifurcatio aortae, arteriae coronariae,
        arteria carotis communis, arteria carotis externa, arteria carotis interna, arteriae
        cerebrales, truncus brachiocephalicus, venae cordis, venae pulmonales, vena cava
        superior and vena cava inferior.
2.7.    'Central nervous system' means the brain, meninges and spinal cord.
2.8.    'Injured skin or mucus membrane' means an area of skin or a mucus membrane presenting
        a pathological change or change following disease or a wound.
                                           Chapter II
                                    Implementing rules
3.1.    Application of the classification rules shall be governed by the intended purpose of the
        devices.
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ANNEX VIII                                     DGB 2C                                            EN
 ---pagebreak--- 3.2.    If the device in question is intended to be used in combination with another device, the
        classification rules shall apply separately to each of the devices. Accessories for a medical
        device and for a product listed in Annex XVI shall be classified in their own right
        separately from the device with which they are used.
3.3.    Software, which drives a device or influences the use of a device, shall fall within the same
        class as the device.
        If the software is independent of any other device, it shall be classified in its own right.
3.4.    If the device is not intended to be used solely or principally in a specific part of the body, it
        shall be considered and classified on the basis of the most critical specified use.
3.5.    If several rules, or if, within the same rule, several sub-rules, apply to the same device
        based on the device's intended purpose, the strictest rule and sub-rule resulting in the
        higher classification shall apply.
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ANNEX VIII                                      DGB 2C                                             EN
 ---pagebreak--- 3.6.    In calculating the duration referred to in Section 1, continuous use shall mean:
        (a)   the entire duration of use of the same device without regard to temporary interruption
              of use during a procedure or temporary removal for purposes such as cleaning or
              disinfection of the device. Whether the interruption of use or the removal is
              temporary shall be established in relation to the duration of the use prior to and after
              the period when the use is interrupted or the device removed; and
        (b)   the accumulated use of a device that is intended by the manufacturer to be replaced
              immediately with another of the same type.
3.7.    A device is considered to allow direct diagnosis when it provides the diagnosis of the
        disease or condition in question by itself or when it provides decisive information for the
        diagnosis.
                                           Chapter III
                                     Classification rules
4.      NON-INVASIVE DEVICES
4.1.    Rule 1
        All non-invasive devices are classified as class I, unless one of the rules set out hereinafter
        applies.
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ANNEX VIII                                     DGB 2C                                             EN
 ---pagebreak--- 4.2.    Rule 2
        All non-invasive devices intended for channelling or storing blood, body liquids, cells or
        tissues, liquids or gases for the purpose of eventual infusion, administration or introduction
        into the body are classified as class IIa:
        –      if they may be connected to a class IIa, class IIb or class III active device; or
        –      if they are intended for use for channelling or storing blood or other body liquids or
               for storing organs, parts of organs or body cells and tissues, except for blood bags;
               blood bags are classified as class IIb.
        In all other cases such devices are classified as class I.
4.3.    Rule 3
        All non-invasive devices intended for modifying the biological or chemical composition of
        human tissues or cells, blood, other body liquids or other liquids intended for implantation
        or administration into the body are classified as class IIb, unless the treatment for which
        the device is used consists of filtration, centrifugation or exchanges of gas, heat, in which
        case they are classified as class IIa.
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ANNEX VIII                                      DGB 2C                                            EN
 ---pagebreak---         All non-invasive devices consisting of a substance or a mixture of substances intended to
        be used in vitro in direct contact with human cells, tissues or organs taken from the human
        body or used in vitro with human embryos before their implantation or administration into
        the body are classified as class III.
4.4.    Rule 4
        All non-invasive devices which come into contact with injured skin or mucous membrane
        are classified as:
        –     class I if they are intended to be used as a mechanical barrier, for compression or for
              absorption of exudates;
        –     class IIb if they are intended to be used principally for injuries to skin which have
              breached the dermis or mucous membrane and can only heal by secondary intent;
        –     class IIa if they are principally intended to manage the micro-environment of injured
              skin or mucous membrane; and
        –     class IIa in all other cases.
        This rule applies also to the invasive devices that come into contact with injured mucous
        membrane.
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ANNEX VIII                                      DGB 2C                                            EN
 ---pagebreak--- 5.      INVASIVE DEVICES
5.1.    Rule 5
        All invasive devices with respect to body orifices, other than surgically invasive devices,
        which are not intended for connection to an active device or which are intended for
        connection to a class I active device are classified as:
        –      class I if they are intended for transient use;
        –      class IIa if they are intended for short-term use, except if they are used in the oral
               cavity as far as the pharynx, in an ear canal up to the ear drum or in the nasal cavity,
               in which case they are classified as class I; and
        –      class IIb if they are intended for long-term use, except if they are used in the oral
               cavity as far as the pharynx, in an ear canal up to the ear drum or in the nasal cavity
               and are not liable to be absorbed by the mucous membrane, in which case they are
               classified as class IIa.
        All invasive devices with respect to body orifices, other than surgically invasive devices,
        intended for connection to a class IIa, class IIb or class III active device, are classified as
        class IIa.
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ANNEX VIII                                       DGB 2C                                              EN
 ---pagebreak--- 5.2.    Rule 6
        All surgically invasive devices intended for transient use are classified as class IIa unless
        they:
        –     are intended specifically to control, diagnose, monitor or correct a defect of the heart
              or of the central circulatory system through direct contact with those parts of the
              body, in which case they are classified as class III;
        –     are reusable surgical instruments, in which case they are classified as class I;
        –     are intended specifically for use in direct contact with the heart or central circulatory
              system or the central nervous system, in which case they are classified as class III;
        –     are intended to supply energy in the form of ionising radiation in which case they are
              classified as class IIb;
        –     have a biological effect or are wholly or mainly absorbed in which case they are
              classified as class IIb; or
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ANNEX VIII                                     DGB 2C                                              EN
 ---pagebreak---         –     are intended to administer medicinal products by means of a delivery system, if such
              administration of a medicinal product is done in a manner that is potentially
              hazardous taking account of the mode of application, in which case they are
              classified as class IIb.
5.3.    Rule 7
        All surgically invasive devices intended for short-term use are classified as class IIa unless
        they:
        –     are intended specifically to control, diagnose, monitor or correct a defect of the heart
              or of the central circulatory system through direct contact with those parts of the
              body, in which case they are classified as class III;
        –     are intended specifically for use in direct contact with the heart or central circulatory
              system or the central nervous system, in which case they are classified as class III;
        –     are intended to supply energy in the form of ionizing radiation in which case they are
              classified as class IIb;
        –     have a biological effect or are wholly or mainly absorbed in which case they are
              classified as class III;
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ANNEX VIII                                     DGB 2C                                              EN
 ---pagebreak---         –     are intended to undergo chemical change in the body in which case they are
              classified as class IIb, except if the devices are placed in the teeth; or
        –     are intended to administer medicines, in which case they are classified as class IIb.
5.4.    Rule 8
        All implantable devices and long-term surgically invasive devices are classified as class IIb
        unless they:
        –     are intended to be placed in the teeth, in which case they are classified as class IIa;
        –     are intended to be used in direct contact with the heart, the central circulatory system
              or the central nervous system, in which case they are classified as class III;
        –     have a biological effect or are wholly or mainly absorbed, in which case they are
              classified as class III;
        –     are intended to undergo chemical change in the body in which case they are
              classified as class III, except if the devices are placed in the teeth;
        –     are intended to administer medicinal products, in which case they are classified as
              class III;
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ANNEX VIII                                       DGB 2C                                            EN
 ---pagebreak---         –      are active implantable devices or their accessories, in which cases they are classified
               as class III;
        –      are breast implants or surgical meshes, in which cases they are classified as class III;
        –      are total or partial joint replacements, in which case they are classified as class III,
               with the exception of ancillary components such as screws, wedges, plates and
               instruments; or
        –      are spinal disc replacement implants or are implantable devices that come into
               contact with the spinal column, in which case they are classified as class III with the
               exception of components such as screws, wedges, plates and instruments.
6.      ACTIVE DEVICES
6.1.    Rule 9
        All active therapeutic devices intended to administer or exchange energy are classified as
        class IIa unless their characteristics are such that they may administer energy to or
        exchange energy with the human body in a potentially hazardous way, taking account of
        the nature, the density and site of application of the energy, in which case they are
        classified as class IIb.
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ANNEX VIII                                       DGB 2C                                             EN
 ---pagebreak---         All active devices intended to control or monitor the performance of active therapeutic
        class IIb devices, or intended directly to influence the performance of such devices are
        classified as class IIb.
        All active devices intended to emit ionizing radiation for therapeutic purposes, including
        devices which control or monitor such devices, or which directly influence their
        performance, are classified as class IIb.
        All active devices that are intended for controlling, monitoring or directly influencing the
        performance of active implantable devices are classified as class III.
6.2.    Rule 10
        Active devices intended for diagnosis and monitoring are classified as class IIa:
        –      if they are intended to supply energy which will be absorbed by the human body,
               except for devices intended to illuminate the patient's body, in the visible spectrum,
               in which case they are classified as class I;
        –      if they are intended to image in vivo distribution of radiopharmaceuticals; or
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ANNEX VIII                                     DGB 2C                                              EN
 ---pagebreak---         –     if they are intended to allow direct diagnosis or monitoring of vital physiological
              processes, unless they are specifically intended for monitoring of vital physiological
              parameters and the nature of variations of those parameters is such that it could result
              in immediate danger to the patient, for instance variations in cardiac performance,
              respiration, activity of the central nervous system, or they are intended for diagnosis
              in clinical situations where the patient is in immediate danger, in which cases they
              are classified as class IIb.
        Active devices intended to emit ionizing radiation and intended for diagnostic or
        therapeutic radiology, including interventional radiology devices and devices which
        control or monitor such devices, or which directly influence their performance, are
        classified as class IIb.
6.3.    Rule 11
        Software intended to provide information which is used to take decisions with diagnosis or
        therapeutic purposes is classified as class IIa, except if such decisions have an impact that
        may cause:
        –     death or an irreversible deterioration of a person's state of health, in which case it is
              in class III; or
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ANNEX VIII                                      DGB 2C                                             EN
 ---pagebreak---         –      a serious deterioration of a person's state of health or a surgical intervention, in which
               case it is classified as class IIb.
        Software intended to monitor physiological processes is classified as class IIa, except if it
        is intended for monitoring of vital physiological parameters, where the nature of variations
        of those parameters is such that it could result in immediate danger to the patient, in which
        case it is classified as class IIb.
        All other software are classified as class I.
6.4.    Rule 12
        All active devices intended to administer and/or remove medicinal products, body liquids
        or other substances to or from the body are classified as class IIa, unless this is done in a
        manner that is potentially hazardous, taking account of the nature of the substances
        involved, of the part of the body concerned and of the mode of application in which case
        they are classified as class IIb.
6.5.    Rule 13
        All other active devices are classified as class I.
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ANNEX VIII                                         DGB 2C                                           EN
 ---pagebreak--- 7.      SPECIAL RULES
7.1.    Rule 14
        All devices incorporating, as an integral part, a substance which, if used separately, can be
        considered to be a medicinal product, as defined in point 2 of Article 1 of
        Directive 2001/83/EC, including a medicinal product derived from human blood or human
        plasma, as defined in point 10 of Article 1 of that Directive, and that has an action ancillary
        to that of the devices, are classified as class III.
7.2.    Rule 15
        All devices used for contraception or prevention of the transmission of sexually transmitted
        diseases are classified as class IIb, unless they are implantable or long term invasive
        devices, in which case they are classified as class III.
7.3.    Rule 16
        All devices intended specifically to be used for disinfecting, cleaning, rinsing or, where
        appropriate, hydrating contact lenses are classified as class IIb.
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ANNEX VIII                                      DGB 2C                                           EN
 ---pagebreak---         All devices intended specifically to be used for disinfecting or sterilising medical devices
        are classified as class IIa, unless they are disinfecting solutions or washer-disinfectors
        intended specifically to be used for disinfecting invasive devices, as the end point of
        processing, in which case they are classified as class IIb.
        This rule does not apply to devices that are intended to clean devices other than contact
        lenses by means of physical action only.
7.4.    Rule 17
        Devices specifically intended for recording of diagnostic images generated by X-ray
        radiation are classified as class IIa.
7.5.    Rule 18
        All devices manufactured utilising tissues or cells of human or animal origin, or their
        derivatives, which are non-viable or rendered non-viable, are classified as class III, unless
        such devices are manufactured utilising tissues or cells of animal origin, or their
        derivatives, which are non-viable or rendered non-viable and are devices intended to come
        into contact with intact skin only.
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ANNEX VIII                                      DGB 2C                                             EN
 ---pagebreak--- 7.6.    Rule 19
        All devices incorporating or consisting of nanomaterial are classified as:
        –      class III if they present a high or medium potential for internal exposure;
        –      class IIb if they present a low potential for internal exposure; and
        –      class IIa if they present a negligible potential for internal exposure.
7.7.    Rule 20
        All invasive devices with respect to body orifices, other than surgically invasive devices,
        which are intended to administer medicinal products by inhalation are classified as
        class IIa, unless their mode of action has an essential impact on the efficacy and safety of
        the administered medicinal product or they are intended to treat life-threatening conditions,
        in which case they are classified as class IIb.
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ANNEX VIII                                       DGB 2C                                          EN
 ---pagebreak--- 7.8.    Rule 21
        Devices that are composed of substances or of combinations of substances that are
        intended to be introduced into the human body via a body orifice or applied to the skin and
        that are absorbed by or locally dispersed in the human body are classified as:
        –      class III if they, or their products of metabolism, are systemically absorbed by the
               human body in order to achieve the intended purpose;
        –      class III if they achieve their intended purpose in the stomach or lower
               gastrointestinal tract and they, or their products of metabolism, are systemically
               absorbed by the human body;
        –      class IIa if they are applied to the skin or if they are applied in the nasal or oral cavity
               as far as the pharynx, and achieve their intended purpose on those cavities; and
        –      class IIb in all other cases.
7.9.    Rule 22
        Active therapeutic devices with an integrated or incorporated diagnostic function which
        significantly determines the patient management by the device, such as closed loop
        systems or automated external defibrillators, are classified as class III.
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ANNEX VIII                                       DGB 2C                                               EN
 ---pagebreak---                                             ANNEX IX
                          CONFORMITY ASSESSMENT BASED ON
                            A QUALITY MANAGEMENT SYSTEM
                AND ON ASSESSMENT OF TECHNICAL DOCUMENTATION
                                           Chapter I
                             Quality Management System
1.      The manufacturer shall establish, document and implement a quality management system
        as described in Article 10(9) and maintain its effectiveness throughout the life cycle of the
        devices concerned. The manufacturer shall ensure the application of the quality
        management system as specified in Section 2 and shall be subject to audit, as laid down in
        Sections 2.3 and 2.4, and to surveillance as specified in Section 3.
2.      Quality management system assessment
2.1.    The manufacturer shall lodge an application for assessment of its quality management
        system with a notified body. The application shall include:
        –     the name of the manufacturer and address of its registered place of business and any
              additional manufacturing site covered by the quality management system, and, if the
              manufacturer's application is lodged by its authorised representative, the name of the
              authorised representative and the address of the authorised representative's registered
              place of business,
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ANNEX IX                                      DGB 2C                                             EN
 ---pagebreak---         – all relevant information on the device or group of devices covered by the quality
          management system,
        – a written declaration that no application has been lodged with any other notified body
          for the same device-related quality management system, or information about any
          previous application for the same device-related quality management system,
        – a draft of an EU declaration of conformity in accordance with Article 19 and
          Annex IV for the device model covered by the conformity assessment procedure,
        – the documentation on the manufacturer's quality management system,
        – a documented description of the procedures in place to fulfil the obligations arising
          from the quality management system and required under this Regulation and the
          undertaking by the manufacturer in question to apply those procedures,
        – a description of the procedures in place to ensure that the quality management system
          remains adequate and effective, and the undertaking by the manufacturer to apply
          those procedures,
        – the documentation on the manufacturer's post-market surveillance system and, where
          applicable, on the PMCF plan, and the procedures put in place to ensure compliance
          with the obligations resulting from the provisions on vigilance set out in Articles 87
          to 92,
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ANNEX IX                                   DGB 2C                                            EN
 ---pagebreak---         –     a description of the procedures in place to keep up to date the post-market
              surveillance system, and, where applicable, the PMCF plan, and the procedures
              ensuring compliance with the obligations resulting from the provisions on vigilance
              set out in Articles 87 to 92, as well as the undertaking by the manufacturer to apply
              those procedures,
        –     documentation on the clinical evaluation plan, and
        –     a description of the procedures in place to keep up to date the clinical evaluation
              plan, taking into account the state of the art.
2.2.    Implementation of the quality management system shall ensure compliance with this
        Regulation. All the elements, requirements and provisions adopted by the manufacturer for
        its quality management system shall be documented in a systematic and orderly manner in
        the form of a quality manual and written policies and procedures such as quality
        programmes, quality plans and quality records.
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ANNEX IX                                        DGB 2C                                            EN
 ---pagebreak---         Moreover, the documentation to be submitted for the assessment of the quality
        management system shall include an adequate description of, in particular:
        (a) the manufacturer's quality objectives;
        (b) the organisation of the business and in particular:
            –      the organisational structures with the assignment of staff responsibilities in
                   relation to critical procedures, the responsibilities of the managerial staff and
                   their organisational authority,
            –      the methods of monitoring whether the operation of the quality management
                   system is efficient and in particular the ability of that system to achieve the
                   desired design and device quality, including control of devices which fail to
                   conform,
            –      where the design, manufacture and/or final verification and testing of the
                   devices, or parts of any of those processes, is carried out by another party, the
                   methods of monitoring the efficient operation of the quality management
                   system and in particular the type and extent of control applied to the other
                   party, and
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ANNEX IX                                      DGB 2C                                              EN
 ---pagebreak---             –     where the manufacturer does not have a registered place of business in a
                  Member State, the draft mandate for the designation of an authorised
                  representative and a letter of intention from the authorised representative to
                  accept the mandate;
        (c) the procedures and techniques for monitoring, verifying, validating and controlling
            the design of the devices and the corresponding documentation as well as the data
            and records arising from those procedures and techniques. Those procedures and
            techniques shall specifically cover:
            –     the strategy for regulatory compliance, including processes for identification of
                  relevant legal requirements, qualification, classification, handling of
                  equivalence, choice of and compliance with conformity assessment procedures,
            –     identification of applicable general safety and performance requirements and
                  solutions to fulfil those requirements, taking applicable CS and, where opted
                  for, harmonised standards or other adequate solutions into account,
            –     risk management as referred to in Section 3 of Annex I,
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ANNEX IX                                      DGB 2C                                           EN
 ---pagebreak---             –      the clinical evaluation, pursuant to Article 61 and Annex XIV, including
                   post-market clinical follow-up,
            –      solutions for fulfilling the applicable specific requirements regarding design
                   and construction, including appropriate pre-clinical evaluation, in particular the
                   requirements of Chapter II of Annex I,
            –      solutions for fulfilling the applicable specific requirements regarding the
                   information to be supplied with the device, in particular the requirements of
                   Chapter III of Annex I,
            –      the device identification procedures drawn up and kept up to date from
                   drawings, specifications or other relevant documents at every stage of
                   manufacture, and
            –      management of design or quality management system changes; and
        (d) the verification and quality assurance techniques at the manufacturing stage and in
            particular the processes and procedures which are to be used, particularly as regards
            sterilisation and the relevant documents; and
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ANNEX IX                                       DGB 2C                                           EN
 ---pagebreak---         (e)   the appropriate tests and trials which are to be carried out before, during and after
              manufacture, the frequency with which they are to take place, and the test equipment
              to be used; it shall be possible to trace back adequately the calibration of that test
              equipment.
        In addition, the manufacturer shall grant the notified body access to the technical
        documentation referred to in Annexes II and III.
2.3.    Audit
        The notified body shall audit the quality management system to determine whether it meets
        the requirements referred to in Section 2.2. Where the manufacturer uses a harmonised
        standard or CS related to a quality management system, the notified body shall assess
        conformity with those standards or CS. The notified body shall assume that a quality
        management system which satisfies the relevant harmonised standards or CS conforms to
        the requirements covered by those standards or CS, unless it duly substantiates not doing
        so.
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ANNEX IX                                        DGB 2C                                             EN
 ---pagebreak---         The audit team of the notified body shall include at least one member with past experience
        of assessments of the technology concerned in accordance with Sections 4.3. to 4.5. of
        Annex VII. In circumstances where such experience is not immediately obvious or
        applicable, the notified body shall provide a documented rationale for the composition of
        that team. The assessment procedure shall include an audit on the manufacturer's premises
        and, if appropriate, on the premises of the manufacturer's suppliers and/or subcontractors to
        verify the manufacturing and other relevant processes.
        Moreover, in the case of class IIa and class IIb devices, the quality management system
        assessment shall be accompanied by the assessment of technical documentation for devices
        selected on a representative basis in accordance with Sections 4.4 to 4.8. In choosing
        representative samples, the notified body shall take into account the published guidance
        developed by the MDCG pursuant to Article 105 and in particular the novelty of the
        technology, similarities in design, technology, manufacturing and sterilisation methods, the
        intended purpose and the results of any previous relevant assessments such as with regard
        to physical, chemical, biological or clinical properties, that have been carried out in
        accordance with this Regulation. The notified body in question shall document its rationale
        for the samples taken.
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ANNEX IX                                       DGB 2C                                           EN
 ---pagebreak---         If the quality management system conforms to the relevant provisions of this Regulation,
        the notified body shall issue an EU quality management system certificate. The notified
        body shall notify the manufacturer of its decision to issue the certificate. The decision shall
        contain the conclusions of the audit and a reasoned report.
2.4.    The manufacturer in question shall inform the notified body which approved the quality
        management system of any plan for substantial changes to the quality management system,
        or the device-range covered. The notified body shall assess the changes proposed,
        determine the need for additional audits and verify whether after those changes the quality
        management system still meets the requirements referred to in Section 2.2. It shall notify
        the manufacturer of its decision which shall contain the conclusions of the assessment, and
        where applicable, conclusions of additional audits. The approval of any substantial change
        to the quality management system or the device-range covered shall take the form of a
        supplement to the EU quality management system certificate.
3.      Surveillance assessment applicable to class IIa, class IIb and class III devices
3.1.    The aim of surveillance is to ensure that the manufacturer duly fulfils the obligations
        arising from the approved quality management system.
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ANNEX IX                                      DGB 2C                                              EN
 ---pagebreak--- 3.2.    The manufacturer shall give authorisation to the notified body to carry out all the necessary
        audits, including on-site audits, and supply it with all relevant information, in particular:
        –     the documentation on its quality management system,
        –     documentation on any findings and conclusions resulting from the application of the
              post-market surveillance plan, including the PMCF plan, for a representative sample
              of devices, and of the provisions on vigilance set out in Articles 87 to 92,
        –     the data stipulated in the part of the quality management system relating to design,
              such as the results of analyses, calculations, tests and the solutions adopted regarding
              the risk-management as referred to in Section 4 of Annex I, and
        –     the data stipulated in the part of the quality management system relating to
              manufacture, such as quality control reports and test data, calibration data, and
              records on the qualifications of the personnel concerned.
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ANNEX IX                                        DGB 2C                                             EN
 ---pagebreak--- 3.3.    Notified bodies shall periodically, at least once every 12 months, carry out appropriate
        audits and assessments to make sure that the manufacturer in question applies the approved
        quality management system and the post-market surveillance plan. Those audits and
        assessments shall include audits on the premises of the manufacturer and, if appropriate, of
        the manufacturer's suppliers and/or subcontractors. At the time of such on-site audits, the
        notified body shall, where necessary, carry out or ask for tests in order to check that the
        quality management system is working properly. It shall provide the manufacturer with a
        surveillance audit report and, if a test has been carried out, with a test report.
3.4.    The notified body shall randomly perform at least once every five years unannounced
        audits on the site of the manufacturer and, where appropriate, of the manufacturer's
        suppliers and/or subcontractors, which may be combined with the periodic surveillance
        assessment referred to in Section 3.3. or be performed in addition to that surveillance
        assessment. The notified body shall establish a plan for such unannounced on-site audits
        but shall not disclose it to the manufacturer.
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ANNEX IX                                        DGB 2C                                            EN
 ---pagebreak---         Within the context of such unannounced on-site audits, the notified body shall test an
        adequate sample of the devices produced or an adequate sample from the manufacturing
        process to verify that the manufactured device is in conformity with the technical
        documentation, with the exception of the devices referred to in the second subparagraph of
        Article 52(8). Prior to unannounced on-site audits, the notified body shall specify the
        relevant sampling criteria and testing procedure.
        Instead of, or in addition to, sampling referred to in the second paragraph, the notified body
        shall take samples of devices from the market to verify that the manufactured device is in
        conformity with the technical documentation, with the exception of the devices referred to
        in the second subparagraph of Article 52(8). Prior to the sampling, the notified body in
        question shall specify the relevant sampling criteria and testing procedure.
        The notified body shall provide the manufacturer in question with an on-site audit report
        which shall include, if applicable, the result of the sample test.
3.5.    In the case of class IIa and class IIb devices, the surveillance assessment shall also include
        an assessment of the technical documentation as referred to in Sections 4.4 to 4.8 for the
        device or devices concerned on the basis of further representative samples chosen in
        accordance with the rationale documented by the notified body in accordance with the
        second paragraph of Section 2.3.
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ANNEX IX                                        DGB 2C                                            EN
 ---pagebreak---         In the case of class III devices, the surveillance assessment shall also include a test of the
        approved parts and/or materials that are essential for the integrity of the device, including,
        where appropriate, a check that the quantities of produced or purchased parts and/or
        materials correspond to the quantities of finished devices.
3.6.    The notified body shall ensure that the composition of the assessment team is such that
        there is sufficient experience with the evaluation of the devices, systems and processes
        concerned, continuous objectivity and neutrality; this shall include a rotation of the
        members of the assessment team at appropriate intervals. As a general rule, a lead auditor
        shall neither lead nor attend audits for more than three consecutive years in respect of the
        same manufacturer.
3.7.    If the notified body finds a divergence between the sample taken from the devices
        produced or from the market and the specifications laid down in the technical
        documentation or the approved design, it shall suspend or withdraw the relevant certificate
        or impose restrictions on it.
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ANNEX IX                                        DGB 2C                                             EN
 ---pagebreak---                                             Chapter II
                    Assessment of the technical documentation
4.      Assessment of the technical documentation applicable to class III devices and to the
        class IIb devices referred to in the second subparagraph of Article 52(4)
4.1.    In addition to the obligations laid down in Section 2, the manufacturer shall lodge with the
        notified body an application for assessment of the technical documentation relating to the
        device which it plans to place on the market or put into service and which is covered by the
        quality management system referred to in Section 2.
4.2.    The application shall describe the design, manufacture and performance of the device in
        question. It shall include the technical documentation as referred to in Annexes II and III.
4.3.    The notified body shall examine the application by using staff, employed by it, with proven
        knowledge and experience regarding the technology concerned and its clinical application.
        The notified body may require the application to be completed by having further tests
        carried out or requesting further evidence to be provided to allow assessment of conformity
        with the relevant requirements of the Regulation. The notified body shall carry out
        adequate physical or laboratory tests in relation to the device or request the manufacturer to
        carry out such tests.
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ANNEX IX                                        DGB 2C                                          EN
 ---pagebreak--- 4.4.    The notified body shall review the clinical evidence presented by the manufacturer in the
        clinical evaluation report and the related clinical evaluation that was conducted. The
        notified body shall employ device reviewers with sufficient clinical expertise and, if
        necessary, use external clinical experts with direct and current experience relating to the
        device in question or the clinical condition in which it is utilised, for the purposes of that
        review.
4.5.    The notified body shall, in circumstances in which the clinical evidence is based partly or
        totally on data from devices which are claimed to be equivalent to the device under
        assessment, assess the suitability of using such data, taking into account factors such as
        new indications and innovation. The notified body shall clearly document its conclusions
        on the claimed equivalence, and on the relevance and adequacy of the data for
        demonstrating conformity. For any characteristic of the device claimed as innovative by
        the manufacturer or for new indications, the notified body shall assess to what extent
        specific claims are supported by specific pre-clinical and clinical data and risk analysis.
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ANNEX IX                                       DGB 2C                                               EN
 ---pagebreak--- 4.6.    The notified body shall verify that the clinical evidence and the clinical evaluation are
        adequate and shall verify the conclusions drawn by the manufacturer on the conformity
        with the relevant general safety and performance requirements. That verification shall
        include consideration of the adequacy of the benefit-risk determination, the risk
        management, the instructions for use, the user training and the manufacturer's post-market
        surveillance plan, and include a review of the need for, and the adequacy of, the PMCF
        plan proposed, where applicable.
4.7.    Based on its assessment of the clinical evidence, the notified body shall consider the
        clinical evaluation and the benefit-risk determination and whether specific milestones need
        to be defined to allow the notified body to review updates to the clinical evidence that
        result from post-market surveillance and PMCF data.
4.8.    The notified body shall clearly document the outcome of its assessment in the clinical
        evaluation assessment report.
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ANNEX IX                                       DGB 2C                                             EN
 ---pagebreak--- 4.9.    The notified body shall provide the manufacturer with a report on the technical
        documentation assessment, including a clinical evaluation assessment report. If the device
        conforms to the relevant provisions of this Regulation, the notified body shall issue an
        EU technical documentation assessment certificate. The certificate shall contain the
        conclusions of the technical documentation assessment, the conditions of the certificate's
        validity, the data needed for identification of the approved design, and, where appropriate,
        a description of the intended purpose of the device.
4.10.   Changes to the approved device shall require approval from the notified body which issued
        the EU technical documentation assessment certificate where such changes could affect the
        safety and performance of the device or the conditions prescribed for use of the device.
        Where the manufacturer plans to introduce any of the above-mentioned changes it shall
        inform the notified body which issued the EU technical documentation assessment
        certificate thereof. The notified body shall assess the planned changes and decide whether
        the planned changes require a new conformity assessment in accordance with Article 52 or
        whether they could be addressed by means of a supplement to the EU technical
        documentation assessment certificate. In the latter case, the notified body shall assess the
        changes, notify the manufacturer of its decision and, where the changes are approved,
        provide it with a supplement to the EU technical documentation assessment certificate.
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ANNEX IX                                       DGB 2C                                             EN
 ---pagebreak--- 5.      Specific additional procedures
5.1.    Assessment procedure for certain class III and class IIb devices
        (a)  For class III implantable devices, and for class IIb active devices intended to
             administer and/or remove a medicinal product as referred to in Section 6.4. of
             Annex VIII (Rule 12), the notified body shall, having verified the quality of clinical
             data supporting the clinical evaluation report of the manufacturer referred to in
             Article 61(12), prepare a clinical evaluation assessment report which sets out its
             conclusions concerning the clinical evidence provided by the manufacturer, in
             particular concerning the benefit-risk determination, the consistency of that evidence
             with the intended purpose, including the medical indication or indications and the
             PMCF plan referred to in Article 10(3) and Part B of Annex XIV.
             The notified body shall transmit its clinical evaluation assessment report, along with
             the manufacturer's clinical evaluation documentation, referred to in points (c) and (d)
             of Section 6.1 of Annex II, to the Commission.
             The Commission shall immediately transmit those documents to the relevant expert
             panel referred to in Article 106.
        (b)  The notified body may be requested to present its conclusions as referred to in
             point (a) to the expert panel concerned.
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ANNEX IX                                      DGB 2C                                            EN
 ---pagebreak---         (c) The expert panel shall decide, under the supervision of the Commission, on the basis
            of all of the following criteria:
            (i)    the novelty of the device or of the related clinical procedure involved, and the
                   possible major clinical or health impact thereof;
            (ii)   a significantly adverse change in the benefit-risk profile of a specific category
                   or group of devices due to scientifically valid health concerns in respect of
                   components or source material or in respect of the impact on health in the case
                   of failure of the device;
            (iii) a significantly increased rate of serious incidents reported in accordance with
                   Article 87 in respect of a specific category or group of devices,
            whether to provide a scientific opinion on the clinical evaluation assessment report of
            the notified body based on the clinical evidence provided by the manufacturer, in
            particular concerning the benefit-risk determination, the consistency of that evidence
            with the medical indication or indications and the PMCF plan. That scientific opinion
            shall be provided within a period of 60 days, starting on the day of receipt of the
            documents from the Commission as referred to in point (a). The reasons for the
            decision to provide a scientific opinion on the basis of the criteria in points (i), (ii)
            and (iii) shall be included in the scientific opinion. Where the information submitted
            is not sufficient for the expert panel to reach a conclusion, this shall be stated in the
            scientific opinion.
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ANNEX IX                                      DGB 2C                                               EN
 ---pagebreak---         (d) The expert panel may decide, under the supervision of the Commission, on the basis
            of the criteria laid down in point (c) not to provide a scientific opinion, in which case
            it shall inform the notified body as soon as possible and in any event within 21 days
            of receipt of the documents as referred to in point (a) from the Commission. The
            expert panel shall within that time limit provide the notified body and the
            Commission with the reasons for its decision, whereupon the notified body may
            proceed with the certification procedure of that device.
        (e) The expert panel shall within 21 days of receipt of the documents from the
            Commission notify the Commission, through Eudamed whether it intends to provide
            a scientific opinion, pursuant to point (c), or whether it intends not to provide a
            scientific opinion, pursuant to point (d).
        (f) Where no opinion has been delivered within a period of 60 days, the notified body
            may proceed with the certification procedure of the device in question.
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ANNEX IX                                     DGB 2C                                             EN
 ---pagebreak---         (g) The notified body shall give due consideration to the views expressed in the
            scientific opinion of the expert panel. Where the expert panel finds that the level of
            clinical evidence is not sufficient or otherwise gives rise to serious concerns about
            the benefit-risk determination, the consistency of that evidence with the intended
            purpose, including the medical indication(s), and with the PMCF plan, the notified
            body shall, if necessary, advise the manufacturer to restrict the intended purpose of
            the device to certain groups of patients or certain medical indications and/or to
            impose a limit on the duration of validity of the certificate, to undertake specific
            PMCF studies, to adapt the instructions for use or the summary of safety and
            performance, or to impose other restrictions in its conformity assessment report, as
            appropriate. The notified body shall provide a full justification where it has not
            followed the advice of the expert panel in its conformity assessment report and the
            Commission shall without prejudice to Article 109 make both the scientific opinion
            of the expert panel and the written justification provided by the notified body
            publicly available via Eudamed.
        (h) The Commission, after consultation with the Member States and relevant scientific
            experts shall provide guidance for expert panels for consistent interpretation of the
            criteria in point (c) before … [date of application of this Regulation].
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ANNEX IX                                     DGB 2C                                              EN
 ---pagebreak--- 5.2.    Procedure in the case of devices incorporating a medicinal substance
        (a)  Where a device incorporates, as an integral part, a substance which, if used
             separately, may be considered to be a medicinal product within the meaning of
             point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived
             from human blood or human plasma and that has an action ancillary to that of the
             device, the quality, safety and usefulness of the substance shall be verified by
             analogy with the methods specified in Annex I to Directive 2001/83/EC.
        (b)  Before issuing an EU technical documentation assessment certificate, the notified
             body shall, having verified the usefulness of the substance as part of the device and
             taking account of the intended purpose of the device, seek a scientific opinion from
             one of the competent authorities designated by the Member States in accordance with
             Directive 2001/83/EC or from the EMA, either of which to be referred to in this
             Section as 'the medicinal products authority consulted' depending on which has been
             consulted under this point, on the quality and safety of the substance including the
             benefit or risk of the incorporation of the substance into the device. Where the device
             incorporates a human blood or plasma derivative or a substance that, if used
             separately, may be considered to be a medicinal product falling exclusively within
             the scope of the annex to Regulation (EC) No 726/2004, the notified body shall seek
             the opinion of the EMA.
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ANNEX IX                                      DGB 2C                                            EN
 ---pagebreak---         (c) When issuing its opinion, the medicinal products authority consulted shall take into
            account the manufacturing process and the data relating to the usefulness of
            incorporation of the substance into the device as determined by the notified body.
        (d) The medicinal products authority consulted shall provide its opinion to the notified
            body within 210 days of receipt of all the necessary documentation.
        (e) The scientific opinion of the medicinal products authority consulted, and any
            possible update of that opinion, shall be included in the documentation of the notified
            body concerning the device. The notified body shall give due consideration to the
            views expressed in the scientific opinion when making its decision. The notified
            body shall not deliver the certificate if the scientific opinion is unfavourable and shall
            convey its final decision to the medicinal products authority consulted.
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ANNEX IX                                     DGB 2C                                             EN
 ---pagebreak---         (f) Before any change is made with respect to an ancillary substance incorporated in a
            device, in particular related to its manufacturing process, the manufacturer shall
            inform the notified body of the changes. That notified body shall seek the opinion of
            the medicinal products authority consulted, in order to confirm that the quality and
            safety of the ancillary substance remain unchanged. The medicinal products authority
            consulted shall take into account the data relating to the usefulness of incorporation
            of the substance into the device as determined by the notified body, in order to
            ensure that the changes have no negative impact on the risk or benefit previously
            established concerning the incorporation of the substance into the device. The
            medicinal products authority consulted shall provide its opinion within 60 days after
            receipt of all the necessary documentation regarding the changes. The notified body
            shall not deliver the supplement to the EU technical documentation assessment
            certificate if the scientific opinion provided by the medicinal products authority
            consulted is unfavourable. The notified body shall convey its final decision to the
            medicinal products authority consulted.
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ANNEX IX                                       DGB 2C                                          EN
 ---pagebreak---         (g) Where the medicinal products authority consulted obtains information on the
            ancillary substance, which could have an impact on the risk or benefit previously
            established concerning the incorporation of the substance into the device, it shall
            advise the notified body as to whether this information has an impact on the risk or
            benefit previously established concerning the incorporation of the substance into the
            device. The notified body shall take that advice into account in reconsidering its
            assessment of the conformity assessment procedure.
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ANNEX IX                                    DGB 2C                                             EN
 ---pagebreak--- 5.3.    Procedure in the case of devices manufactured utilising, or incorporating, tissues or cells of
        human or animal origin, or their derivatives, that are non-viable or rendered non-viable
5.3.1.  Tissues or cells of human origin or their derivatives
        (a)  For devices manufactured utilising derivatives of tissues or cells of human origin that
             are covered by this Regulation in accordance with point (g) of Article 1(6) and for
             devices that incorporate, as an integral part, tissues or cells of human origin, or their
             derivatives, covered by Directive 2004/23/EC, that have an action ancillary to that of
             the device, the notified body shall, prior to issuing an EU technical documentation
             assessment certificate, seek a scientific opinion from one of the competent authorities
             designated by the Member States in accordance with Directive 2004/23/EC ('human
             tissues and cells competent authority') on the aspects relating to the donation,
             procurement and testing of tissues or cells of human origin or their derivatives. The
             notified body shall submit a summary of the preliminary conformity assessment
             which provides, among other things, information about the non-viability of the
             human tissues or cells in question, their donation, procurement and testing and the
             risk or benefit of the incorporation of the tissues or cells of human origin or their
             derivatives into the device.
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ANNEX IX                                      DGB 2C                                              EN
 ---pagebreak---         (b) Within 120 days of receipt of all the necessary documentation, the human tissues and
            cells competent authority shall provide to the notified body its opinion.
        (c) The scientific opinion of the human tissues and cells competent authority, and any
            possible update, shall be included in the documentation of the notified body
            concerning the device. The notified body shall give due consideration to the views
            expressed in the scientific opinion of the human tissues and cells competent authority
            when making its decision. The notified body shall not deliver the certificate if that
            scientific opinion is unfavourable. It shall convey its final decision to the human
            tissues and cells competent authority concerned.
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ANNEX IX                                     DGB 2C                                             EN
 ---pagebreak---         (d) Before any change is made with respect to non-viable tissues or cells of human
            origin or their derivatives incorporated in a device, in particular relating to their
            donation, testing or procurement, the manufacturer shall inform the notified body of
            the intended changes. The notified body shall consult the authority that was involved
            in the initial consultation, in order to confirm that the quality and safety of the tissues
            or cells of human origin or their derivatives incorporated in the device are
            maintained. The human tissues and cells competent authority concerned shall take
            into account the data relating to the usefulness of incorporation of the tissues or cells
            of human origin or their derivatives into the device as determined by the notified
            body, in order to ensure that the changes have no negative impact on the established
            benefit-risk ratio of the addition of the tissues or cells of human origin or their
            derivatives in the device. It shall provide its opinion within 60 days of receipt of all
            the necessary documentation regarding the intended changes. The notified body shall
            not deliver a supplement to the EU technical documentation assessment certificate if
            the scientific opinion is unfavourable and shall convey its final decision to the human
            tissues and cells competent authority concerned.
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ANNEX IX                                      DGB 2C                                              EN
 ---pagebreak--- 5.3.2.  Tissues or cells of animal origin or their derivatives
        In the case of devices manufactured utilising animal tissue which is rendered non-viable or
        utilising non-viable products derived from animal tissue, as referred to in
        Regulation (EU) No 722/2012, the notified body shall apply the relevant requirements laid
        down in that Regulation.
5.4.    Procedure in the case of devices that are composed of substances or of combinations of
        substances that are absorbed by or locally dispersed in the human body
        (a)    The quality and safety of devices that are composed of substances or of combinations
               of substances that are intended to be introduced into the human body via a body
               orifice or applied to the skin and that are absorbed by, or locally dispersed in, the
               human body, shall be verified where applicable and only in respect of the
               requirements not covered by this Regulation, in accordance with the relevant
               requirements laid down in Annex I to Directive 2001/83/EC for the evaluation of
               absorption, distribution, metabolism, excretion, local tolerance, toxicity, interaction
               with other devices, medicinal products or other substances and potential for adverse
               reactions.
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ANNEX IX                                        DGB 2C                                             EN
 ---pagebreak---         (b) In addition, for devices, or their products of metabolism, that are systemically
            absorbed by the human body in order to achieve their intended purpose, the notified
            body shall seek a scientific opinion from one of the competent authorities designated
            by the Member States in accordance with Directive 2001/83/EC or from the EMA,
            either of which to be referred to in this Section as 'the medicinal products authority
            consulted' depending on which has been consulted under this point, on the
            compliance of the device with the relevant requirements laid down in Annex I to
            Directive 2001/83/EC.
        (c) The opinion of the medicinal products authority consulted shall be drawn up within
            150 days of receipt of all the necessary documentation.
        (d) The scientific opinion of the medicinal products authority consulted, and any
            possible update, shall be included in the documentation of the notified body
            concerning the device. The notified body shall give due consideration to the views
            expressed in the scientific opinion when making its decision and shall convey its
            final decision to the medicinal products authority consulted.
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ANNEX IX                                      DGB 2C                                           EN
 ---pagebreak--- 6.      Batch verification in the case of devices incorporating, as an integral part, a medicinal
        substance which, if used separately, would be considered to be a medicinal product derived
        from human blood or human plasma as referred to in Article 1(8)
        Upon completing the manufacture of each batch of devices that incorporate, as an integral
        part, a medicinal substance which, if used separately, would be considered to be a
        medicinal product derived from human blood or human plasma as referred to in the first
        subparagraph of Article 1(8), the manufacturer shall inform the notified body of the release
        of the batch of devices and send it the official certificate concerning the release of the
        batch of human blood or plasma derivative used in the device, issued by a Member State
        laboratory or a laboratory designated for that purpose by a Member State in accordance
        with Article 114(2) of Directive 2001/83/EC.
                                          Chapter III
                                Administrative provisions
7.      The manufacturer or, where the manufacturer does not have a registered place of business
        in a Member State, its authorised representative shall, for a period ending no sooner than
        ten years, and in the case of implantable devices no sooner than 15 years, after the last
        device has been placed on the market, keep at the disposal of the competent authorities:
        –      the EU declaration of conformity,
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ANNEX IX                                       DGB 2C                                              EN
 ---pagebreak---         –     the documentation referred to in the fifth indent of Section 2.1 and in particular the
              data and records arising from the procedures referred to in point (c) of the second
              paragraph of Section 2.2,
        –     information on the changes referred to in Section 2.4,
        –     the documentation referred to in Section 4.2, and
        –     the decisions and reports from the notified body as referred to in this Annex.
8.      Each Member State shall require that the documentation referred to in Section 7 is kept at
        the disposal of competent authorities for the period indicated in that Section in case a
        manufacturer, or its authorised representative, established within its territory goes bankrupt
        or ceases its business activity prior to the end of that period.
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ANNEX IX                                        DGB 2C                                            EN
 ---pagebreak---                                              ANNEX X
              CONFORMITY ASSESSMENT BASED ON TYPE EXAMINATION
1.      EU type-examination is the procedure whereby a notified body ascertains and certifies that
        a device, including its technical documentation and relevant life cycle processes and a
        corresponding representative sample of the device production envisaged, fulfil the relevant
        provisions of this Regulation.
2.      Application
        The manufacturer shall lodge an application for assessment with a notified body. The
        application shall include:
        –     the name of the manufacturer and address of the registered place of business of the
              manufacturer and, if the application is lodged by the authorised representative, the
              name of the authorised representative and the address of its registered place of
              business,
        –     the technical documentation referred to in Annexes II and III. The applicant shall
              make a representative sample of the device production envisaged ('type') available to
              the notified body. The notified body may request other samples as necessary, and
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ANNEX X                                       DGB 2C                                            EN
 ---pagebreak---         –    a written declaration that no application has been lodged with any other notified body
             for the same type, or information about any previous application for the same type
             that was refused by another notified body or was withdrawn by the manufacturer or
             its authorised representative before that other notified body made its final
             assessment.
3.      Assessment
        The notified body shall:
        (a)  examine the application by using staff with proven knowledge and experience
             regarding the technology concerned and its clinical application. The notified body
             may require the application to be completed by having further tests carried out or
             requesting further evidence to be provided to allow assessment of conformity with
             the relevant requirements of this Regulation. The notified body shall carry out
             adequate physical or laboratory tests in relation to the device or request the
             manufacturer to carry out such tests;
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ANNEX X                                      DGB 2C                                            EN
 ---pagebreak---         (b) examine and assess the technical documentation for conformity with the
            requirements of this Regulation that are applicable to the device and verify that the
            type has been manufactured in conformity with that documentation; it shall also
            record the items designed in conformity with the applicable standards referred to in
            Article 8 or with applicable CS, and record the items not designed on the basis of the
            relevant standards referred to in Article 8 or of the relevant CS;
        (c) review the clinical evidence presented by the manufacturer in the clinical evaluation
            report in accordance with Section 4 of Annex XIV. The notified body shall employ
            device reviewers with sufficient clinical expertise and, if necessary, use external
            clinical experts with direct and current experience relating to the device in question
            or to the clinical condition in which it is utilised, for the purposes of that review;
        (d) in circumstances in which the clinical evidence is based partly or totally on data from
            devices which are claimed to be similar or equivalent to the device under assessment,
            assess the suitability of using such data, taking into account factors such as new
            indications and innovation. The notified body shall clearly document its conclusions
            on the claimed equivalence, and on the relevance and adequacy of the data for
            demonstrating conformity;
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ANNEX X                                       DGB 2C                                              EN
 ---pagebreak---         (e) clearly document the outcome of its assessment in a pre-clinical and clinical
            evaluation assessment report as part of the EU type examination report referred to in
            point (i);
        (f) carry out or arrange for the appropriate assessments and the physical or laboratory
            tests necessary to verify whether the solutions adopted by the manufacturer meet the
            general safety and performance requirements laid down in this Regulation in the
            event that the standards referred to in Article 8 or the CS have not been applied.
            Where the device has to be connected to another device or devices in order to operate
            as intended, proof shall be provided that it conforms to the general safety and
            performance requirements when connected to any such device or devices having the
            characteristics specified by the manufacturer;
        (g) carry out or arrange for the appropriate assessments and the physical or laboratory
            tests necessary to verify whether, in the event that the manufacturer has chosen to
            apply the relevant harmonised standards, those standards have actually been applied;
        (h) agree with the applicant on the place where the necessary assessments and tests are
            to be carried out; and
        (i) draw up an EU type-examination report on the results of the assessments and tests
            carried out under points (a) to (g).
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ANNEX X                                      DGB 2C                                            EN
 ---pagebreak--- 4.      Certificate
        If the type conforms to this Regulation, the notified body shall issue an
        EU type-examination certificate. The certificate shall contain the name and address of the
        manufacturer, the conclusions of the type examination assessment, the conditions of the
        certificate's validity and the data needed for identification of the type approved. The
        certificate shall be drawn up in accordance with Annex XII. The relevant parts of the
        documentation shall be annexed to the certificate and a copy kept by the notified body.
5.      Changes to the type
5.1.    The applicant shall inform the notified body which issued the EU type-examination
        certificate of any planned change to the approved type or of its intended purpose and
        conditions of use.
5.2.    Changes to the approved device including limitations of its intended purpose and
        conditions of use shall require approval from the notified body which issued the
        EU type-examination certificate where such changes may affect conformity with the
        general safety and performance requirements or with the conditions prescribed for use of
        the product. The notified body shall examine the planned changes, notify the manufacturer
        of its decision and provide him with a supplement to the EU type-examination report. The
        approval of any change to the approved type shall take the form of a supplement to the
        EU type-examination certificate.
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ANNEX X                                         DGB 2C                                          EN
 ---pagebreak--- 5.3.    Changes to the intended purpose and conditions of use of the approved device, with the
        exception of limitations of the intended purpose and conditions of use, shall necessitate a
        new application for a conformity assessment.
6.      Specific additional procedures
        Section 5 of Annex IX shall apply with the proviso that any reference to an EU technical
        documentation assessment certificate shall be understood as a reference to an
        EU type-examination certificate.
7.      Administrative provisions
        The manufacturer or, where the manufacturer does not have a registered place of business
        in a Member State, its authorised representative shall, for a period ending no sooner than
        ten years, and in the case of implantable devices no sooner than 15 years, after the last
        device has been placed on the market, keep at the disposal of the competent authorities:
        –     the documentation referred to in the second indent of Section 2,
        –     information on the changes referred to in Section 5, and
        –     copies of EU type-examination certificates, scientific opinions and reports and their
              additions/supplements.
        Section 8 of Annex IX shall apply.
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ANNEX X                                       DGB 2C                                              EN
 ---pagebreak---                                              ANNEX XI
                             CONFORMITY ASSESSMENT BASED
                         ON PRODUCT CONFORMITY VERIFICATION
1.      The objective of the conformity assessment based on product conformity verification is to
        ensure that devices conform to the type for which an EU type-examination certificate has
        been issued, and that they meet the provisions of this Regulation which apply to them.
2.      Where an EU type-examination certificate has been issued in accordance with Annex X,
        the manufacturer may either apply the procedure set out in Part A (production quality
        assurance) or the procedure set out in Part B (product verification) of this Annex.
3.      By way of derogation from Sections 1 and 2 above, the procedures in this Annex coupled
        with the drawing up of technical documentation as set out in Annexes II and III may also
        be applied by manufacturers of class IIa devices.
                                              PART A
                             PRODUCTION QUALITY ASSURANCE
4.      The manufacturer shall ensure that the quality management system approved for the
        manufacture of the devices concerned is implemented, shall carry out a final verification,
        as specified in Section 6, and shall be subject to the surveillance referred to in Section 7.
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ANNEX XI                                       DGB 2C                                              EN
 ---pagebreak--- 5.      When the manufacturer fulfils the obligations laid down in Section 4, it shall draw up and
        keep an EU declaration of conformity in accordance with Article 19 and Annex IV for the
        device covered by the conformity assessment procedure. By issuing an EU declaration of
        conformity, the manufacturer shall be deemed to ensure and to declare that the device
        concerned conforms to the type described in the EU type-examination certificate and meets
        the requirements of this Regulation which apply to the device.
6.      Quality management system
6.1.    The manufacturer shall lodge an application for assessment of its quality management
        system with a notified body. The application shall include:
        –     all elements listed in Section 2.1 of Annex IX,
        –     the technical documentation referred to in Annexes II and III for the types approved,
              and
        –     a copy of the EU-type examination certificates referred to in Section 4 of Annex X; if
              the EU-type examination certificates have been issued by the same notified body
              with which the application is lodged, a reference to the technical documentation and
              its updates and the certificates issued shall also be included in the application.
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ANNEX XI                                        DGB 2C                                           EN
 ---pagebreak--- 6.2.    Implementation of the quality management system shall be such as to ensure that there is
        compliance with the type described in the EU type-examination certificate and with the
        provisions of this Regulation which apply to the devices at each stage. All the elements,
        requirements and provisions adopted by the manufacturer for its quality management
        system shall be documented in a systematic and orderly manner in the form of a quality
        manual and written policies and procedures, such as quality programmes, quality plans and
        quality records.
        That documentation shall, in particular, include an adequate description of all elements
        listed in points (a), (b), (d) and (e) of Section 2.2 of Annex IX.
6.3.    The first and second paragraph of Section 2.3 of Annex IX shall apply.
        If the quality management system is such that it ensures that the devices conform to the
        type described in the EU type-examination certificate and that it conforms to the relevant
        provisions of this Regulation, the notified body shall issue an EU quality assurance
        certificate. The notified body shall notify the manufacturer of its decision to issue the
        certificate. That decision shall contain the conclusions of the notified body's audit and a
        reasoned assessment.
6.4.    Section 2.4 of Annex IX shall apply.
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ANNEX XI                                          DGB 2C                                          EN
 ---pagebreak--- 7.      Surveillance
        Section 3.1, the first, second and fourth indents of Section 3.2, Sections 3.3, 3.4, 3.6 and
        3.7 of Annex IX shall apply.
        In the case of class III devices, surveillance shall also include a check that the quantities of
        produced or purchased raw material or crucial components approved for the type and
        correspond to the quantities of finished devices.
8.      Batch verification in the case of devices incorporating, as an integral part, a medicinal
        substance which, if used separately, would be considered to be a medicinal product derived
        from human blood or human plasma referred to in Article 1(8).
        Upon completing the manufacture of each batch of devices that incorporate, as an integral
        part, a medicinal substance which, if used separately, would be considered to be a
        medicinal product derived from human blood or human plasma referred to in the first
        subparagraph of Article 1(8), the manufacturer shall inform the notified body of the release
        of the batch of devices and send it the official certificate concerning the release of the
        batch of human blood or plasma derivative used in the device, issued by a Member State
        laboratory or a laboratory designated for that purpose by a Member State in accordance
        with Article 114(2) of Directive 2001/83/EC.
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ANNEX XI                                        DGB 2C                                             EN
 ---pagebreak--- 9.      Administrative provisions
        The manufacturer or, where the manufacturer does not have a registered place of business
        in a Member State, its authorised representative shall, for a period ending no sooner than
        ten years, and in the case of implantable devices no sooner than 15 years, after the last
        device has been placed on the market, keep at the disposal of the competent authorities:
        –     the EU declaration of conformity,
        –     the documentation referred to in the fifth indent of Section 2.1 of Annex IX,
        –     the documentation referred to in the eighth indent of Section 2.1 of Annex IX,
              including the EU type-examination certificate referred to in Annex X,
        –     information on the changes referred to in Section 2.4 of Annex IX, and
        –     the decisions and reports from the notified body as referred to in Sections 2.3, 3.3
              and 3.4 of Annex IX.
        Section 8 of Annex IX shall apply.
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ANNEX XI                                      DGB 2C                                              EN
 ---pagebreak--- 10.     Application to class IIa devices
10.1.   By way of derogation from Section 5, by virtue of the EU declaration of conformity the
        manufacturer shall be deemed to ensure and to declare that the class IIa devices in question
        are manufactured in conformity with the technical documentation referred to in Annexes II
        and III and meet the requirements of this Regulation which apply to them.
10.2.   For class IIa devices the notified body shall assess, as part of the assessment referred to in
        Section 6.3, whether the technical documentation as referred to in Annexes II and III for
        the devices selected on a representative basis is compliant with this Regulation.
        In choosing a representative sample or samples of devices, the notified body shall take into
        account the novelty of the technology, similarities in design, technology, manufacturing
        and sterilisation methods, the intended use and the results of any previous relevant
        assessments (e.g. with regard to physical, chemical, biological or clinical properties) that
        have been carried out in accordance with this Regulation. The notified body shall
        document its rationale for the sample or samples of devices taken.
10.3.   Where the assessment under Section 10.2. confirms that the class IIa devices in question
        conform to the technical documentation referred to in Annexes II and III and meet the
        requirements of this Regulation which apply to them, the notified body shall issue a
        certificate pursuant to this Part of this Annex.
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ANNEX XI                                         DGB 2C                                           EN
 ---pagebreak--- 10.4.   Samples additional to those taken for the initial conformity assessment of devices shall be
        assessed by the notified body as part of the surveillance assessment referred to in
        Section 7.
10.5.   By way of derogation from Section 6, the manufacturer or its authorised representative
        shall, for a period ending no sooner than ten years after the last device has been placed on
        the market, keep at the disposal of the competent authorities:
        –      the EU declaration of conformity,
        –      the technical documentation referred to in Annexes II and III, and
        –      the certificate referred to in Section 10.3.
        Section 8 of Annex IX shall apply.
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ANNEX XI                                         DGB 2C                                          EN
 ---pagebreak---                                                 PART B
                                    PRODUCT VERIFICATION
11.     Product verification shall be understood to be the procedure whereby after examination of
        every manufactured device, the manufacturer, by issuing an EU declaration of conformity
        in accordance with Article 19 and Annex IV, shall be deemed to ensure and to declare that
        the devices which have been subject to the procedure set out in Sections 14 and 15
        conform to the type described in the EU type-examination certificate and meet the
        requirements of this Regulation which apply to them.
12.     The manufacturer shall take all the measures necessary to ensure that the manufacturing
        process produces devices which conform to the type described in the EU type-examination
        certificate and to the requirements of the Regulation which apply to them. Prior to the start
        of manufacture, the manufacturer shall prepare documents defining the manufacturing
        process, in particular as regards sterilisation where necessary, together with all routine,
        pre-established procedures to be implemented to ensure homogeneous production and,
        where appropriate, conformity of the devices with the type described in the
        EU type-examination certificate and with the requirements of this Regulation which apply
        to them.
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ANNEX XI                                        DGB 2C                                            EN
 ---pagebreak---         In addition, for devices placed on the market in a sterile condition, and only for those
        aspects of the manufacturing process designed to secure and maintain sterility, the
        manufacturer shall apply the provisions of Sections 6 and 7.
13.     The manufacturer shall undertake to institute and keep up to date a post-market
        surveillance plan, including a PMCF plan, and the procedures ensuring compliance with
        the obligations of the manufacturer resulting from the provisions on vigilance and
        post-market surveillance system set out in Chapter VII.
14.     The notified body shall carry out the appropriate examinations and tests in order to verify
        the conformity of the device with the requirements of the Regulation by examining and
        testing every product as specified in Section 15.
        The examinations and tests referred to in the first paragraph of this Section shall not apply
        to aspects of the manufacturing process designed to secure sterility.
15.     Verification by examination and testing of every product
15.1.   Every device shall be examined individually and the appropriate physical or laboratory
        tests as defined in the relevant standard or standards referred to in Article 8, or equivalent
        tests and assessments, shall be carried out in order to verify, where appropriate, the
        conformity of the devices with the type described in the EU type-examination certificate
        and with the requirements of this Regulation which apply to them.
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ANNEX XI                                       DGB 2C                                              EN
 ---pagebreak--- 15.2.   The notified body shall affix, or have affixed, its identification number to each approved
        device and shall draw up an EU product verification certificate relating to the tests and
        assessments carried out.
16.     Batch verification in the case of devices incorporating, as an integral part, a medicinal
        substance which, if used separately, would be considered to be a medicinal product derived
        from human blood or human plasma referred to in Article 1(8).
        Upon completing the manufacture of each batch of devices that incorporate, as an integral
        part, a medicinal substance which, if used separately, would be considered to be a
        medicinal product derived from human blood or human plasma referred to in the first
        subparagraph of Article 1(8), the manufacturer shall inform the notified body of the release
        of the batch of devices and send it the official certificate concerning the release of the
        batch of human blood or plasma derivative used in the device, issued by a Member State
        laboratory or a laboratory designated for that purpose by a Member State in accordance
        with Article 114(2) of Directive 2001/83/EC.
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ANNEX XI                                       DGB 2C                                              EN
 ---pagebreak--- 17.     Administrative provisions
        The manufacturer or its authorised representative shall, for a period ending no sooner than
        ten years, and in the case of implantable devices no sooner than 15 years, after the last
        device has been placed on the market, keep at the disposal of the competent authorities:
        –     the EU declaration of conformity,
        –     the documentation referred to in Section 12,
        –     the certificate referred to in Section 15.2, and
        –     the EU type-examination certificate referred to in Annex X.
        Section 8 of Annex IX shall apply.
18.     Application to class IIa devices
18.1.   By way of derogation from Section 11, by virtue of the EU declaration of conformity the
        manufacturer shall be deemed to ensure and to declare that the class IIa devices in question
        are manufactured in conformity with the technical documentation referred to in Annexes II
        and III and meet the requirements of this Regulation which apply to them.
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ANNEX XI                                        DGB 2C                                            EN
 ---pagebreak--- 18.2.   The verification conducted by the notified body in accordance with Section 14 is intended
        to confirm the conformity of the class IIa devices in question with the technical
        documentation referred to in Annexes II and III and with the requirements of this
        Regulation which apply to them.
18.3.   If the verification referred to in Section 18.2 confirms that the class IIa devices in question
        conform to the technical documentation referred to in Annexes II and III and meet the
        requirements of this Regulation which apply to them, the notified body shall issue a
        certificate pursuant to this Part of this Annex.
18.4.   By way of derogation from Section 17, the manufacturer or its authorised representative
        shall, for a period ending no sooner than ten years after the last device has been placed on
        the market, keep at the disposal of the competent authorities:
        –      the EU declaration of conformity,
        –      the technical documentation referred to in Annexes II and III, and
        –      the certificate referred to in Section 18.3.
        Section 8 of Annex IX shall apply.
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ANNEX XI                                         DGB 2C                                            EN
 ---pagebreak---                                              ANNEX XII
                        CERTIFICATES ISSUED BY A NOTIFIED BODY
                                             Chapter I
                                   General Requirements
1.      Certificates shall be drawn up in one of the official languages of the Union.
2.      Each certificate shall refer to only one conformity assessment procedure.
3.      Certificates shall only be issued to one manufacturer. The name and address of the
        manufacturer included in the certificate shall be the same as that registered in the electronic
        system referred to in Article 30.
4.      The scope of the certificates shall unambiguously identify the device or devices covered:
        (a)   EU technical documentation assessment certificates, EU type-examination
              certificates and EU product verification certificates shall include a clear
              identification, including the name, model and type, of the device or devices, the
              intended purpose, as included by the manufacturer in the instructions for use and in
              relation to which the device has been assessed in the conformity assessment
              procedure, risk classification and the Basic UDI-DI as referred to in Article 27(6);
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ANNEX XII                                      DGB 2C                                             EN
 ---pagebreak---         (b)    EU quality management system certificates and EU quality assurance certificates
               shall include the identification of the devices or groups of devices, the risk
               classification, and, for class IIb devices, the intended purpose.
5.      The notified body shall be able to demonstrate on request, which (individual) devices are
        covered by the certificate. The notified body shall set up a system that enables the
        determination of the devices, including their classification, covered by the certificate.
6.      Certificates shall contain, if applicable, a note that, for the placing on the market of the
        device or devices it covers, another certificate issued in accordance with this Regulation is
        required.
7.      EU quality management system certificates and EU quality assurance certificates for
        class I devices for which the involvement of a notified body is required pursuant to
        Article 52(7) shall include a statement that the audit by the notified body of the quality
        management system was limited to the aspects required under that paragraph.
8.      Where a certificate is supplemented, modified or re-issued, the new certificate shall contain
        a reference to the preceding certificate and its date of issue with identification of the
        changes.
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ANNEX XII                                        DGB 2C                                             EN
 ---pagebreak---                                             Chapter II
                         Minimum content of the certificates
1.      name, address and identification number of the notified body;
2.      name and address of the manufacturer and, if applicable, of the authorised representative;
3.      unique number identifying the certificate;
4.      if already issued, the SRN of the manufacturer referred to in to Article 31(2);
5.      date of issue;
6.      date of expiry;
7.      data needed for the unambiguous identification of the device or devices where applicable
        as specified in Section 4 of Part I;
8.      if applicable, reference to any previous certificate as specified in Section 8 of Chapter I;
9.      reference to this Regulation and the relevant Annex in accordance with which the
        conformity assessment has been carried out;
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ANNEX XII                                     DGB 2C                                              EN
 ---pagebreak--- 10.     examinations and tests performed, e.g. reference to relevant CS, harmonised standards, test
        reports and audit report(s);
11.     if applicable, reference to the relevant parts of the technical documentation or other
        certificates required for the placing on the market of the device or devices covered;
12.     if applicable, information about the surveillance by the notified body;
13.     conclusions of the notified body's conformity assessment with regard to the relevant
        Annex;
14.     conditions for or limitations to the validity of the certificate;
15.     legally binding signature of the notified body in accordance with the applicable national
        law.
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ANNEX XII                                      DGB 2C                                          EN
 ---pagebreak---                                             ANNEX XIII
                         PROCEDURE FOR CUSTOM-MADE DEVICES
1.      For custom-made devices, the manufacturer or its authorised representative shall draw up a
        statement containing all of the following information:
        –     the name and address of the manufacturer, and of all manufacturing sites,
        –     if applicable, the name and address of the authorised representative,
        –     data allowing identification of the device in question,
        –     a statement that the device is intended for exclusive use by a particular patient or
              user, identified by name, an acronym or a numerical code,
        –     the name of the person who made out the prescription and who is authorised by
              national law by virtue of their professional qualifications to do so, and, where
              applicable, the name of the health institution concerned,
        –     the specific characteristics of the product as indicated by the prescription,
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ANNEX XIII                                      DGB 2C                                            EN
 ---pagebreak---         –     a statement that the device in question conforms to the general safety and
              performance requirements set out in Annex I and, where applicable, indicating which
              general safety and performance requirements have not been fully met, together with
              the grounds,
        –     where applicable, an indication that the device contains or incorporates a medicinal
              substance, including a human blood or plasma derivative, or tissues or cells of human
              origin, or of animal origin as referred to in Regulation (EU) No 722/2012.
2.      The manufacturer shall undertake to keep available for the competent national authorities
        documentation that indicates its manufacturing site or sites and allows an understanding to
        be formed of the design, manufacture and performance of the device, including the
        expected performance, so as to allow assessment of conformity with the requirements of
        this Regulation.
3.      The manufacturer shall take all the measures necessary to ensure that the manufacturing
        process produces devices which are manufactured in accordance with the documentation
        referred to in Section 2.
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ANNEX XIII                                     DGB 2C                                          EN
 ---pagebreak--- 4.      The statement referred to in the introductory part of Section 1 shall be kept for a period of
        at least ten years after the device has been placed on the market. In the case of implantable
        devices, the period shall be at least 15 years.
        Section 8 of Annex IX shall apply.
5.      The manufacturer shall review and document experience gained in the post-production
        phase, including from PMCF as referred to in Part B of Annex XIV, and implement
        appropriate means to apply any necessary corrective action, In that context, it shall report
        in accordance with Article 87(1) to the competent authorities any serious incidents or field
        safety corrective actions or both as soon as it learns of them.
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ANNEX XIII                                      DGB 2C                                           EN
 ---pagebreak---                                             ANNEX XIV
                                    CLINICAL EVALUATION
                         AND POST-MARKET CLINICAL FOLLOW-UP
                                               PART A
                                    CLINICAL EVALUATION
1.      To plan, continuously conduct and document a clinical evaluation, manufacturers shall:
        (a)   establish and update a clinical evaluation plan, which shall include at least:
              –     an identification of the general safety and performance requirements that
                    require support from relevant clinical data;
              –     a specification of the intended purpose of the device;
              –     a clear specification of intended target groups with clear indications and
                    contra-indications;
              –     a detailed description of intended clinical benefits to patients with relevant and
                    specified clinical outcome parameters;
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ANNEX XIV                                      DGB 2C                                            EN
 ---pagebreak---           – a specification of methods to be used for examination of qualitative and
            quantitative aspects of clinical safety with clear reference to the determination
            of residual risks and side-effects;
          – an indicative list and specification of parameters to be used to determine,
            based on the state of the art in medicine, the acceptability of the benefit-risk
            ratio for the various indications and for the intended purpose or purposes of
            the device;
          – an indication how benefit-risk issues relating to specific components such as
            use of pharmaceutical, non-viable animal or human tissues, are to be
            addressed; and
          – a clinical development plan indicating progression from exploratory
            investigations, such as first-in-man studies, feasibility and pilot studies, to
            confirmatory investigations, such as pivotal clinical investigations, and a
            PMCF as referred to in Part B of this Annex with an indication of milestones
            and a description of potential acceptance criteria;
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ANNEX XIV                              DGB 2C                                               EN
 ---pagebreak---         (b)   identify available clinical data relevant to the device and its intended purpose and
              any gaps in clinical evidence through a systematic scientific literature review;
        (c)   appraise all relevant clinical data by evaluating their suitability for establishing the
              safety and performance of the device;
        (d)   generate, through properly designed clinical investigations in accordance with the
              clinical development plan, any new or additional clinical data necessary to address
              outstanding issues; and
        (e)   analyse all relevant clinical data in order to reach conclusions about the safety and
              clinical performance of the device including its clinical benefits.
2.      The clinical evaluation shall be thorough and objective, and take into account both
        favourable and unfavourable data. Its depth and extent shall be proportionate and
        appropriate to the nature, classification, intended purpose and risks of the device in
        question, as well as to the manufacturer's claims in respect of the device.
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ANNEX XIV                                       DGB 2C                                              EN
 ---pagebreak--- 3.      A clinical evaluation may be based on clinical data relating to a device for which
        equivalence to the device in question can be demonstrated. The following technical,
        biological and clinical characteristics shall be taken into consideration for the
        demonstration of equivalence:
        –     Technical: the device is of similar design; is used under similar conditions of use; has
              similar specifications and properties including physicochemical properties such as
              intensity of energy, tensile strength, viscosity, surface characteristics, wavelength
              and software algorithms; uses similar deployment methods, where relevant; has
              similar principles of operation and critical performance requirements;
        –     Biological: the device uses the same materials or substances in contact with the same
              human tissues or body fluids for a similar kind and duration of contact and similar
              release characteristics of substances, including degradation products and leachables;
        –     Clinical: the device is used for the same clinical condition or purpose, including
              similar severity and stage of disease, at the same site in the body, in a similar
              population, including as regards age, anatomy and physiology; has the same kind of
              user; has similar relevant critical performance in view of the expected clinical effect
              for a specific intended purpose.
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ANNEX XIV                                       DGB 2C                                            EN
 ---pagebreak---         The characteristics listed in the first paragraph shall be similar to the extent that there
        would be no clinically significant difference in the safety and clinical performance of the
        device. Considerations of equivalence shall be based on proper scientific justification. It
        shall be clearly demonstrated that manufacturers have sufficient levels of access to the data
        relating to devices with which they are claiming equivalence in order to justify their claims
        of equivalence.
4.      The results of the clinical evaluation and the clinical evidence on which it is based shall be
        documented in a clinical evaluation report which shall support the assessment of the
        conformity of the device.
        The clinical evidence together with non-clinical data generated from non-clinical testing
        methods and other relevant documentation shall allow the manufacturer to demonstrate
        conformity with the general safety and performance requirements and shall be part of the
        technical documentation for the device in question.
        Both favourable and unfavourable data considered in the clinical evaluation shall be
        included in the technical documentation.
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ANNEX XIV                                        DGB 2C                                             EN
 ---pagebreak---                                               PART B
                            POST-MARKET CLINICAL FOLLOW-UP
5.      PMCF shall be understood to be a continuous process that updates the clinical evaluation
        referred to in Article 61 and Part A of this Annex and shall be addressed in the
        manufacturer's post-market surveillance plan. When conducting PMCF, the manufacturer
        shall proactively collect and evaluate clinical data from the use in or on humans of a device
        which bears the CE marking and is placed on the market or put into service within its
        intended purpose as referred to in the relevant conformity assessment procedure, with the
        aim of confirming the safety and performance throughout the expected lifetime of the
        device, of ensuring the continued acceptability of identified risks and of detecting
        emerging risks on the basis of factual evidence.
6.      PMCF shall be performed pursuant to a documented method laid down in a PMCF plan.
6.1.    The PMCF plan shall specify the methods and procedures for proactively collecting and
        evaluating clinical data with the aim of:
        (a)   confirming the safety and performance of the device throughout its expected lifetime,
        (b)   identifying previously unknown side-effects and monitoring the identified
              side-effects and contraindications,
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ANNEX XIV                                      DGB 2C                                           EN
 ---pagebreak---         (c)  identifying and analysing emergent risks on the basis of factual evidence,
        (d)  ensuring the continued acceptability of the benefit-risk ratio referred to in Sections 1
             and 9 of Annex I, and
        (e)  identifying possible systematic misuse or off-label use of the device, with a view to
             verifying that the intended purpose is correct.
6.2.    The PMCF plan shall include at least:
        (a)  the general methods and procedures of the PMCF to be applied, such as gathering of
             clinical experience gained, feedback from users, screening of scientific literature and
             of other sources of clinical data;
        (b)  the specific methods and procedures of PMCF to be applied, such as evaluation of
             suitable registers or PMCF studies;
        (c)  a rationale for the appropriateness of the methods and procedures referred to in
             points (a) and (b);
        (d)  a reference to the relevant parts of the clinical evaluation report referred to in
             Section 4 and to the risk management referred to in Section 3 of Annex I;
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ANNEX XIV                                     DGB 2C                                             EN
 ---pagebreak---         (e)   the specific objectives to be addressed by the PMCF;
        (f)   an evaluation of the clinical data relating to equivalent or similar devices;
        (g)   reference to any relevant CS, harmonised standards when used by the manufacturer,
              and relevant guidance on PMCF; and
        (h)   a detailed and adequately justified time schedule for PMCF activities (e.g. analysis of
              PMCF data and reporting) to be undertaken by the manufacturer.
7.      The manufacturer shall analyse the findings of the PMCF and document the results in a
        PMCF evaluation report that shall be part of the clinical evaluation report and the technical
        documentation.
8.      The conclusions of the PMCF evaluation report shall be taken into account for the clinical
        evaluation referred to in Article 61 and Part A of this Annex and in the risk management
        referred to in Section 3 of Annex I. If, through the PMCF, the need for preventive and/or
        corrective measures has been identified, the manufacturer shall implement them.
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ANNEX XIV                                      DGB 2C                                           EN
 ---pagebreak---                                               ANNEX XV
                                   CLINICAL INVESTIGATIONS
                                             Chapter I
                                    General requirements
1.      Ethical principles
        Each step in the clinical investigation, from the initial consideration of the need for and
        justification of the study to the publication of the results, shall be carried out in accordance
        with recognised ethical principles.
2.      Methods
        2.1. Clinical investigations shall be performed on the basis of an appropriate plan of
               investigation reflecting the latest scientific and technical knowledge and defined in
               such a way as to confirm or refute the manufacturer's claims regarding the safety,
               performance and aspects relating to benefit-risk of devices as referred to in
               Article 62(1); the clinical investigations shall include an adequate number of
               observations to guarantee the scientific validity of the conclusions. The rationale for
               the design and chosen statistical methodology shall be presented as further described
               in Section 3.6 of Chapter II of this Annex.
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ANNEX XV                                        DGB 2C                                              EN
 ---pagebreak---         2.2. The procedures used to perform the clinical investigation shall be appropriate to the
             device under investigation.
        2.3. The research methodologies used to perform the clinical investigation shall be
             appropriate to the device under investigation.
        2.4. Clinical investigations shall be performed in accordance with the clinical
             investigation plan by a sufficient number of intended users and in a clinical
             environment that is representative of the intended normal conditions of use of the
             device in the target patient population. Clinical investigations shall be in line with the
             clinical evaluation plan as referred to in Part A of Annex XIV.
        2.5. All the appropriate technical and functional features of the device, in particular those
             involving safety and performance, and their expected clinical outcomes shall be
             appropriately addressed in the investigational design. A list of the technical and
             functional features of the device and the related expected clinical outcomes shall be
             provided.
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ANNEX XV                                      DGB 2C                                              EN
 ---pagebreak---         2.6. The endpoints of the clinical investigation shall address the intended purpose,
             clinical benefits, performance and safety of the device. The endpoints shall be
             determined and assessed using scientifically valid methodologies. The primary
             endpoint shall be appropriate to the device and clinically relevant.
        2.7. Investigators shall have access to the technical and clinical data regarding the device.
             Personnel involved in the conduct of an investigation shall be adequately instructed
             and trained in the proper use of the investigational device, and as regards the clinical
             investigation plan and good clinical practice. This training shall be verified and
             where necessary arranged by the sponsor and documented appropriately.
        2.8. The clinical investigation report, signed by the investigator, shall contain a critical
             evaluation of all the data collected during the clinical investigation, and shall include
             any negative findings.
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ANNEX XV                                      DGB 2C                                              EN
 ---pagebreak---                                              Chapter II
                     Documentation regarding the application
                                   for clinical investigation
For investigational devices covered by Article 62, the sponsor shall draw up and submit the
application in accordance with Article 70 accompanied by the following documents:
1.       Application form
         The application form shall be duly filled in, containing information regarding:
         1.1. name, address and contact details of the sponsor and, if applicable, name, address
               and contact details of its contact person or legal representative in accordance with
               Article 62(2) established in the Union;
         1.2. if different from those in Section 1.1, name, address and contact details of the
               manufacturer of the device intended for clinical investigation and, if applicable, of its
               authorised representative;
         1.3. title of the clinical investigation;
         1.4. status of the clinical investigation application (i.e. first submission, resubmission,
               significant amendment);
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ANNEX XV                                         DGB 2C                                            EN
 ---pagebreak---         1.5. details and/or reference to the clinical evaluation plan;
        1.6. If the application is a resubmission with regard to a device for which an application
              has been already submitted, the date or dates and reference number or numbers of the
              earlier application or in the case of significant amendment, reference to the original
              application. The sponsor shall identify all of the changes from the previous
              application together with a rationale for those changes, in particular, whether any
              changes have been made to address conclusions of previous competent authority or
              ethics committee reviews;
        1.7. if the application is submitted in parallel with an application for a clinical trial in
              accordance with Regulation (EU) No 536/2014, reference to the official registration
              number of the clinical trial;
        1.8. identification of the Member States and third countries in which the clinical
              investigation is to be conducted as part of a multicentre or multinational study at the
              time of application;
        1.9. a brief description of the investigational device, its classification and other
              information necessary for the identification of the device and device type;
        1.10. information as to whether the device incorporates a medicinal substance, including a
              human blood or plasma derivative or whether it is manufactured utilising non-viable
              tissues or cells of human or animal origin, or their derivatives;
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ANNEX XV                                       DGB 2C                                               EN
 ---pagebreak---         1.11. summary of the clinical investigation plan including the objective or objectives of the
              clinical investigation, the number and gender of subjects, criteria for subject
              selection, whether there are subjects under 18 years of age, design of the
              investigation such as controlled and/or randomised studies, planned dates of
              commencement and of completion of the clinical investigation;
        1.12. if applicable, information regarding a comparator device, its classification and other
              information necessary for the identification of the comparator device;
        1.13. evidence from the sponsor that the clinical investigator and the investigational site
              are capable of conducting the clinical investigation in accordance with the clinical
              investigation plan;
        1.14. details of the anticipated start date and duration of the investigation;
        1.15. details to identify the notified body, if already involved at the stage of application for
              a clinical investigation;
        1.16. confirmation that the sponsor is aware that the competent authority may contact the
              ethics committee that is assessing or has assessed the application; and
        1.17. the statement referred to in Section 4.1.
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ANNEX XV                                        DGB 2C                                             EN
 ---pagebreak--- 2.      Investigator's Brochure
        The investigator's brochure (IB) shall contain the clinical and non-clinical information on
        the investigational device that is relevant for the investigation and available at the time of
        application. Any updates to the IB or other relevant information that is newly available
        shall be brought to the attention of the investigators in a timely manner. The IB shall be
        clearly identified and contain in particular the following information:
        2.1. Identification and description of the device, including information on the intended
              purpose, the risk classification and applicable classification rule pursuant to
              Annex VIII, design and manufacturing of the device and reference to previous and
              similar generations of the device.
        2.2. Manufacturer's instructions for installation, maintenance, maintaining hygiene
              standards and for use, including storage and handling requirements, as well as, to the
              extent that such information is available, information to be placed on the label, and
              instructions for use to be provided with the device when placed on the market. In
              addition, information relating to any relevant training required.
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ANNEX XV                                        DGB 2C                                             EN
 ---pagebreak---         2.3. Pre-clinical evaluation based on relevant pre-clinical testing and experimental data,
             in particular regarding in-design calculations, in vitro tests, ex vivo tests, animal tests,
             mechanical or electrical tests, reliability tests, sterilisation validation, software
             verification and validation, performance tests, evaluation of biocompatibility and
             biological safety, as applicable.
        2.4. Existing clinical data, in particular:
             –     from relevant scientific literature available relating to the safety, performance,
                   clinical benefits to patients, design characteristics and intended purpose of the
                   device and/or of equivalent or similar devices;
             –     other relevant clinical data available relating to the safety, performance,
                   clinical benefits to patients, design characteristics and intended purpose of
                   equivalent or similar devices of the same manufacturer, including length of
                   time on the market and a review of performance, clinical benefit and safety-
                   related issues and any corrective actions taken.
        2.5. Summary of the benefit-risk analysis and the risk management, including
             information regarding known or foreseeable risks, any undesirable effects,
             contraindications and warnings.
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ANNEX XV                                       DGB 2C                                              EN
 ---pagebreak---         2.6. In the case of devices that incorporate a medicinal substance, including a human
             blood or plasma derivative or devices manufactured utilising non-viable tissues or
             cells of human or animal origin, or their derivatives, detailed information on the
             medicinal substance or on the tissues, cells or their derivatives, and on the
             compliance with the relevant general safety and performance requirements and the
             specific risk management in relation to the substance or tissues, cells or their
             derivatives, as well as evidence for the added value of incorporation of such
             constituents in relation to the clinical benefit and/or safety of the device.
        2.7. A list detailing the fulfilment of the relevant general safety and performance
             requirements set out in Annex I, including the standards and CS applied, in full or in
             part, as well as a description of the solutions for fulfilling the relevant general safety
             and performance requirements, in so far as those standards and CS have not or have
             only been partly fulfilled or are lacking.
        2.8. A detailed description of the clinical procedures and diagnostic tests used in the
             course of the clinical investigation and in particular information on any deviation
             from normal clinical practice.
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ANNEX XV                                       DGB 2C                                              EN
 ---pagebreak--- 3.      Clinical Investigation Plan
        The clinical investigation plan (CIP) shall set out the rationale, objectives, design
        methodology, monitoring, conduct, record-keeping and the method of analysis for the
        clinical investigation. It shall contain in particular the information as laid down in this
        Annex. If part of this information is submitted in a separate document, it shall be
        referenced in the CIP.
        3.1. General
              3.1.1. Single identification number of the clinical investigation, as referred to in
                     Article 70(1).
              3.1.2. Identification of the sponsor – name, address and contact details of the sponsor
                     and, where applicable, the name, address and contact details of the sponsor's
                     contact person or legal representative in accordance with Article 62(2)
                     established in the Union.
              3.1.3. Information on the principal investigator at each investigational site, the
                     coordinating investigator for the investigation, the address details for each
                     investigational site and the emergency contact details for the principal
                     investigator at each site. The roles, responsibilities and qualifications of the
                     various kinds of investigators shall be specified in the CIP.
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 ---pagebreak---              3.1.4. A brief description of how the clinical investigation is financed and a brief
                    description of the agreement between the sponsor and the site.
             3.1.5. Overall synopsis of the clinical investigation, in an official Union language
                    determined by the Member State concerned.
        3.2. Identification and description of the device, including its intended purpose, its
             manufacturer, its traceability, the target population, materials coming into contact
             with the human body, the medical or surgical procedures involved in its use and the
             necessary training and experience for its use, background literature review, the
             current state of the art in clinical care in the relevant field of application and the
             proposed benefits of the new device.
        3.3. Risks and clinical benefits of the device to be examined, with justification of the
             corresponding expected clinical outcomes in the clinical investigation plan.
        3.4. Description of the relevance of the clinical investigation in the context of the state of
             the art of clinical practice.
        3.5. Objectives and hypotheses of the clinical investigation.
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 ---pagebreak---         3.6. Design of the clinical investigation with evidence of its scientific robustness and
             validity.
             3.6.1. General information such as type of investigation with rationale for choosing it,
                    for its endpoints and for its variables as set out in the clinical evaluation plan.
             3.6.2. Information on the investigational device, on any comparator and on any other
                    device or medication to be used in the clinical investigation.
             3.6.3. Information on subjects, selection criteria, size of investigation population,
                    representativeness of investigation population in relation to target population
                    and, if applicable, information on vulnerable subjects involved such as
                    children, pregnant women, immuno-compromised or, elderly subjects.
             3.6.4. Details of measures to be taken to minimise bias, such as randomisation, and
                    management of potential confounding factors.
             3.6.5. Description of the clinical procedures and diagnostic methods relating to the
                    clinical investigation and in particular highlighting any deviation from normal
                    clinical practice.
             3.6.6. Monitoring plan.
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ANNEX XV                                       DGB 2C                                               EN
 ---pagebreak---         3.7. Statistical considerations, with justification, including a power calculation for the
              sample size, if applicable.
        3.8. Data management.
        3.9. Information about any amendments to the CIP.
        3.10. Policy regarding follow-up and management of any deviations from the CIP at the
              investigational site and clear prohibition of use of waivers from the CIP.
        3.11. Accountability regarding the device, in particular control of access to the device,
              follow-up in relation to the device used in the clinical investigation and the return of
              unused, expired or malfunctioning devices.
        3.12. Statement of compliance with the recognised ethical principles for medical research
              involving humans, and the principles of good clinical practice in the field of clinical
              investigations of devices, as well as with the applicable regulatory requirements.
        3.13. Description of the Informed consent process.
        3.14. Safety reporting, including definitions of adverse events and serious adverse events,
              device deficiencies, procedures and timelines for reporting.
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ANNEX XV                                       DGB 2C                                             EN
 ---pagebreak---         3.15. Criteria and procedures for follow-up of subjects following the end, temporary halt
              or early termination of an investigation, for follow-up of subjects who have
              withdrawn their consent and procedures for subjects lost to follow-up. Such
              procedures shall for implantable devices, cover as a minimum traceability.
        3.16. A description of the arrangements for taking care of the subjects after their
              participation in the clinical investigation has ended, where such additional care is
              necessary because of the subjects' participation in the clinical investigation and
              where it differs from that normally expected for the medical condition in question.
        3.17. Policy as regards the establishment of the clinical investigation report and
              publication of results in accordance with the legal requirements and the ethical
              principles referred to in Section 1 of Chapter I.
        3.18. List of the technical and functional features of the device, with specific mention of
              those covered by the investigation.
        3.19. Bibliography.
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ANNEX XV                                        DGB 2C                                           EN
 ---pagebreak--- 4.      Other information
        4.1. A signed statement by the natural or legal person responsible for the manufacture of
             the investigational device that the device in question conforms to the general safety
             and performance requirements apart from the aspects covered by the clinical
             investigation and that, with regard to those aspects, every precaution has been taken
             to protect the health and safety of the subject.
        4.2. Where applicable according to national law, copy of the opinion or opinions of the
             ethics committee or committees concerned. Where according to national law the
             opinion or opinions of the ethics committee or committees is not required at the time
             of the submission of the application, a copy of the opinion or opinions shall be
             submitted as soon as available.
        4.3. Proof of insurance cover or indemnification of subjects in case of injury, pursuant to
             Article 69 and the corresponding national law.
        4.4. Documents to be used to obtain informed consent, including the patient information
             sheet and the informed consent document.
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 ---pagebreak---         4.5. Description of the arrangements to comply with the applicable rules on the protection
             and confidentiality of personal data, in particular:
             –      organisational and technical arrangements that will be implemented to avoid
                    unauthorised access, disclosure, dissemination, alteration or loss of information
                    and personal data processed;
             –      a description of measures that will be implemented to ensure confidentiality of
                    records and personal data of subjects; and
             –      a description of measures that will be implemented in case of a data security
                    breach in order to mitigate the possible adverse effects.
        4.6. Full details of the available technical documentation, for example detailed risk
             analysis/management documentation or specific test reports shall upon request be
             submitted to the competent authority reviewing an application.
                                          Chapter III
                           Other obligations of the sponsor
1.      The sponsor shall undertake to keep available for the competent national authorities any
        documentation necessary to provide evidence for the documentation referred to in
        Chapter II of this Annex. If the sponsor is not the natural or legal person responsible for the
        manufacture of the investigational device, that obligation may be fulfilled by that person
        on behalf of the sponsor.
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ANNEX XV                                       DGB 2C                                            EN
 ---pagebreak--- 2.      The Sponsor shall have an agreement in place to ensure that any serious adverse events or
        any other event as referred to in Article 80(2) are reported by the investigator or
        investigators to the sponsor in a timely manner.
3.      The documentation mentioned in this Annex shall be kept for a period of time of at least
        ten years after the clinical investigation with the device in question has ended, or, in the
        event that the device is subsequently placed on the market, at least ten years after the last
        device has been placed on the market. In the case of implantable devices, the period shall
        be at least 15 years.
        Each Member State shall require that this documentation is kept at the disposal of the
        competent authorities for the period referred to in the first subparagraph in case the
        sponsor, or its contact person or legal representative as referred to in Article 62(2)
        established within its territory, goes bankrupt or ceases its activity prior to the end of this
        period.
4.      The Sponsor shall appoint a monitor that is independent from the investigational site to
        ensure that the investigation is conducted in accordance with the CIP, the principles of
        good clinical practice and this Regulation.
5.      The Sponsor shall complete the follow-up of investigation subjects.
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ANNEX XV                                        DGB 2C                                              EN
 ---pagebreak--- 6.      The Sponsor shall provide evidence that the investigation is being conducted in line with
        good clinical practice, for instance through internal or external inspection.
7.      The Sponsor shall prepare a clinical investigation report which includes at least the
        following:
        –     Cover/introductory page or pages indicating the title of the investigation, the
              investigational device, the single identification number, the CIP number and the
              details with signatures of the coordinating investigators and the principal
              investigators from each investigational site.
        –     Details of the author and date of the report.
        –     A summary of the investigation covering the title, purpose of the investigation,
              description of the investigation, investigational design and methods used, the results
              of the investigation and conclusion of the investigation. The completion date of the
              investigation, and in particular details of early termination, temporary halts or
              suspensions of investigations.
        –     Investigational device description, in particular clearly defined intended purpose.
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ANNEX XV                                       DGB 2C                                           EN
 ---pagebreak---         – A summary of the clinical investigation plan covering objectives, design, ethical
          aspects, monitoring and quality measures, selection criteria, target patient
          populations, sample size, treatment schedules, follow-up duration, concomitant
          treatments, statistical plan, including hypothesis, sample size calculation and analysis
          methods, as well as a justification.
        – Results of the clinical investigation covering, with rationale and justification, subject
          demographics, analysis of results related to chosen endpoints, details of subgroup
          analysis, as well as compliance with the CIP, and covering follow-up of missing data
          and of patients withdrawing from the clinical investigation, or lost to follow-up.
        – Summary of serious adverse events, adverse device effects and device deficiencies
          and any relevant corrective actions.
        – Discussion and overall conclusions covering safety and performance results,
          assessment of risks and clinical benefits, discussion of clinical relevance in
          accordance with clinical state of the art, any specific precautions for specific patient
          populations, implications for the investigational device, limitations of the
          investigation.
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ANNEX XV                                    DGB 2C                                            EN
 ---pagebreak---                                            ANNEX XVI
                                LIST OF GROUPS OF PRODUCTS
                        WITHOUT AN INTENDED MEDICAL PURPOSE
                                REFERRED TO IN ARTICLE 1(2)
1.      Contact lenses or other items intended to be introduced into or onto the eye.
2.      Products intended to be totally or partially introduced into the human body through
        surgically invasive means for the purpose of modifying the anatomy or fixation of body
        parts with the exception of tattooing products and piercings.
3.      Substances, combinations of substances, or items intended to be used for facial or other
        dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection
        or other introduction, excluding those for tattooing.
4.      Equipment intended to be used to reduce, remove or destroy adipose tissue, such as
        equipment for liposuction, lipolysis or lipoplasty.
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ANNEX XVI                                     DGB 2C                                           EN
 ---pagebreak--- 5.      High intensity electromagnetic radiation (e.g. infra-red, visible light and ultra-violet)
        emitting equipment intended for use on the human body, including coherent and
        non-coherent sources, monochromatic and broad spectrum, such as lasers and intense
        pulsed light equipment, for skin resurfacing, tattoo or hair removal or other skin treatment.
6.      Equipment intended for brain stimulation that apply electrical currents or magnetic or
        electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain.
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ANNEX XVI                                      DGB 2C                                             EN
 ---pagebreak---                                        ANNEX XVII
                                     Correlation table
Council Directive 90/385/EEC   Council Directive 93/42/EEC            This Regulation
Article 1(1)                  Article 1(1)                    Article 1(1)
Article 1(2)                  Article 1(2)                    Article 2
Article 1(3)                  Article 1(3) first subparagraph Article 1(9) first subparagraph
–                             Article 1(3) second             Article 1(9) second
                              subparagraph                    subparagraph
Article 1(4) and (4a)         Article 1(4) and (4a)           Article 1(8) first subparagraph
Article 1(5)                  Article 1(7)                    Article 1(11)
Article 1(6)                  Article 1(5)                    Article 1(6)
–                             Article 1(6)                    –
–                             Article 1(8)                    Article 1(13)
Article 2                     Article 2                       Article 5(1)
Article 3 first subparagraph  Article 3 first subparagraph    Article 5(2)
Article 3 second subparagraph Article 3 second subparagraph   Article 1(12)
Article 4(1)                  Article 4(1)                    Article 24
Article 4(2)                  Article 4(2)                    Article 21(1) and (2)
Article 4(3)                  Article 4(3)                    Article 21(3)
Article 4(4)                  Article 4(4)                    Article 10(11)
Article 4(5)(a)               Article 4(5) first subparagraph Article 20(6)
Article 4(5)(b)               Article 4(5) second             –
                              subparagraph
Article 5(1)                  Article 5(1)                    Article 8(1)
Article 5(2)                  Article 5(2)                    Article 8(2)
Article 6(1)                  Articles 5(3) and 6             –
Article 6(2)                  Article 7(1)                    Article 114
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ANNEX XVII                                 DGB 2C                                         EN
 ---pagebreak--- Council Directive 90/385/EEC  Council Directive 93/42/EEC         This Regulation
Article 7                    Article 8                    Articles 94 to 97
–                            Article 9                    Article 51
Article 8(1)                 Article 10(1)                Articles 87(1) and 89 (2)
Article 8(2)                 Article 10(2)                Article 87(10) and
                                                          Article 87(11) first
                                                          subparagraph
Article 8(3)                 Article 10(3)                Article 89(7)
Article 8(4)                 Article 10(4)                Article 91
Article 9(1)                 Article 11(1)                Article 52(3)
–                            Article 11(2)                Article 52(6)
–                            Article 11(3)                Article 52(4) and (5)
–                            Article 11(4)                –
–                            Article 11(5)                Article 52(7)
Article 9(2)                 Article 11 (6)               Article 52(8)
Article 9(3)                 Article 11(8)                Article 11(3)
Article 9(4)                 Article 11(12)               Article 52(12)
Article 9(5)                 Article 11(7)                –
Article 9(6)                 Article 11(9)                Article 53(1)
Article 9(7)                 Article 11(10)               Article 53(4)
Article 9(8)                 Article 11(11)               Article 56(2)
Article 9(9)                 Article 11(13)               Article 59
Article 9(10)                Article 11(14)               Article 4(5) and Article 122
                                                          third paragraph
–                            Article 12                   Article 22
–                            Article 12a                  Article 17
Article 9a(1) first indent   Article 13(1)(c)             –
Article 9a(1) second indent  Article 13(1)(d)             Article 4(1)
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ANNEX XVII                               DGB 2C                                      EN
 ---pagebreak--- Council Directive 90/385/EEC     Council Directive 93/42/EEC           This Regulation
–                               Article 13(1)(a)               Article 51(3)(a) and
                                                               Article 51(6)
–                               Article 13(1)(b)               Article 51(3)(b) and
                                                               Article 51(6)
Article 10                      Article 15                     Articles 62 to 82
Article 10a(1), second sentence Article 14(1), second sentence Articles 29(4), 30 and 31
of Article 10a(2) and           of Article 14(2) and
Article 10a(3)                  Article 14(3)
Article 10a(2), first sentence  Article 14(2) first sentence   Article 11(1)
Article 10b                     Article 14a                    Articles 33 and 34
Article 10c                     Article 14b                    Article 98
Article 11(1)                   Article 16(1)                  Articles 42 and 43
Article 11(2)                   Article 16(2)                  Article 36
Article 11(3)                   Article 16(3)                  Article 46(4)
Article 11(4)                   Article 16(4)                  –
Article 11(5)                   Article 16(5)                  Article 56(5)
Article 11(6)                   Article 16(6)                  Article 56(4)
Article 11(7)                   Article 16(7)                  Articles 38(2) and 44(2)
Article 12                      Article 17                     Article 20
Article 13                      Article 18                     Articles 94 to 97
Article 14                      Article 19                     Article 99
Article 15                      Article 20                     Article 109
Article 15a                     Article 20a                    Article 102
Article 16                      Article 22                     –
Article 17                      Article 23                     –
–                               Article 21                     –
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ANNEX XVII                                  DGB 2C                                       EN