# Commission Implementing Regulation (EU) No 920/2013Show full title

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 (Text with EEA relevance)         

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# 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                     

# (Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to 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(1), and in particular Article 11(2) thereof,                        

Having regard to Council Directive 93/42/EEC of 14 June 1993 concerning medical devices(2), and in particular Article 16(2) thereof,                        

Whereas:

(1)Technical progress has led to more complex devices and production methods implying new conformity assessment challenges for                              notified bodies. Those developments have resulted in variations in the level of competence of notified bodies and in different                              degrees of stringency applied by them. Accordingly, to ensure the smooth functioning of the internal market, it is necessary                              to determine a common interpretation of the main elements of the criteria for designation of notified bodies set out in Directive                              90/385/EEC and Directive 93/42/EEC.

(2)The common interpretation of the criteria for designation provided by this Regulation does not suffice to assure their consistent                              application. The assessment methods in the Member States differ. They have a tendency to differ ever more due to the mentioned                              increased complexity of the work of conformity assessment bodies. Furthermore, many ad hoc questions arise in the day-to-day                              designation practice, in relation with new technologies and products. For these reasons, it is necessary to provide for procedural                              obligations which ensure a constant dialogue between Member States on their general practices and on ad hoc questions. This                              will bring to the surface discrepancies in the methods used to assess the conformity assessment bodies and in the interpretation                              of the criteria for their designation set out in Directive 90/385/EEC and Directive 93/42/EEC. Bringing the discrepancies                              to the surface will permit to develop a common interpretation of the assessment methods, especially with regard to new technologies                              and devices.

(3)To ensure a common approach from the designating authorities and neutral conditions for competition those authorities should                              base their decisions on a common set of documents which lay the ground for the verification of the criteria for designation                              set out in Directive 90/385/EEC and Directive 93/42/EEC.

(4)To facilitate, in a view of the increasingly complex work of conformity assessment bodies, a common application of the criteria                              established for their designation, those bodies should be assessed by teams of assessors representing the knowledge and experience                              of different Member States and of the Commission. To facilitate such assessments, certain essential documents should be accessible                              to those involved in these activities. Designating authorities from Member States other than the Member State where the conformity                              assessment body is established should have the possibility to review the documentation related to the assessment and to comment                              on intended designations if they so wish. The access to those documents is necessary in order to allow the identification                              of weaknesses of the applicant conformity assessment bodies as well as discrepancies in the Member States’ assessment methods                              and in their interpretation of the criteria for designation set out in Directive 90/385/EEC and Directive 93/42/EEC.

(5)In order to ensure that the common interpretation of the criteria established applies similarly to scope extensions, which                              often reflect new technologies or product types and renewal of designations of notified bodies, the procedure for the designation                              of conformity assessment bodies should also be followed in those situations.

(6)The need for control and monitoring of notified bodies by the designating authorities has increased since technical progress                              has raised the risk that notified bodies do not possess the necessary competence with regard to new technologies or devices                              emerging within their scope of designation. As technical progress shortens product cycles and as the intervals of surveillance                              on-site assessments and of the monitoring vary between designating authorities, minimum requirements with regard to the intervals                              of the surveillance and monitoring of the notified bodies should be established and unannounced or short-notice on-site assessments                              should be organised.

(7)When, in spite of the measures taken to ensure a coherent application and follow up of the requirements by the Member States,                              the competence of a notified body is in doubt, the Commission should have the possibility to investigate individual cases.                              The need for investigation by the Commission is exacerbated since technical progress has increased the risk that notified                              bodies do not possess the necessary competence with regard to new technologies or products falling under their scope of designation.

(8)In order to increase transparency and mutual trust and to further align and develop their designation, extension and renewal                              procedures, above all in a view of new emerging interpretative questions regarding new technologies and devices, Member States                              should cooperate with each other and with the Commission. They should consult each other and the Commission on questions with                              general relevance for the implementation of this Regulation and inform each other and the Commission on their model assessment                              checklist, which constitutes the basis for their assessment practice.

(9)The increased complexity of the tasks regarding the designation of the conformity assessment bodies, reflecting the increasing                              complexity of the work of those bodies, requires significant resources. Therefore, requirements should be imposed on the Member                              States with regard to the minimum level of available competent personnel, able and entrusted to operate in an independent                              way.

(10)Designating authorities who are not in charge of market surveillance and vigilance for medical devices are not necessarily                              aware of deficiencies in the work of notified bodies which were spotted by the competent authorities when doing product checks.                              Furthermore, the designating authorities do not necessarily have all the product related knowledge which is sometimes needed                              to assess whether the notified bodies worked properly. Therefore, the designating authorities should consult the competent                              authorities.

(11)Where designation is based on accreditation in the meaning of 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(3), in order to ensure a transparent and coherent application of the criteria set out in Annex 8 to Directive 90/385/EEC and                              Annex XI to Directive 93/42/EEC, accreditation bodies on the one hand, and designating and competent authorities on the other                              hand should exchange information relevant for the assessment of notified bodies. The need for this exchange of information                              has proven to be particularly strong in respect to the conformity assessment bodies’ practices with regard to new technologies                              and devices and their ability to cover those technologies and devices and thus to fulfil the criteria for designation set                              out in Directive 90/385/EEC and Directive 93/42/EEC.

(12)It is appropriate to provide for a phase-in period, so as to give designating authorities time to build up the necessary additional                              resources and adapt their procedures.

(13)The complex technical and production developments have led some notified bodies to outsource parts of their assessments. It                              is therefore necessary to set the limits and to determine under which conditions this can be done. Notified bodies should                              be in control of their subcontractors and of their subsidiaries. They need to be endowed with the appropriate resources, including                              fully qualified staff to make their own assessments or to review the assessments made by external experts.

(14)To ensure that decisions by notified bodies are not influenced by non-legitimate circumstances the organisation and operation                              of the bodies should ensure full impartiality. To be able to carry out their tasks in a coherent and systematic manner the                              bodies should possess a satisfactory management system including provisions on professional secrecy. In order to allow notified                              bodies to perform their work properly, the level of knowledge and competence of the personnel should be guaranteed at all                              times.

(15)The measures provided for in this Regulation are in accordance with the opinion of the Committee set up by Article 6(2) of                              Directive 90/385/EEC,

HAS ADOPTED THIS REGULATION:

## Article 1U.K.Definitions

For the purposes of this Regulation, the following definitions shall apply:

‘device’ means active implantable medical devices as defined in Article 1(2)(c) of Directive 90/385/EEC or medical devices                              and their accessories as defined in Article 1(2) of Directive 93/42/EEC;                           

‘conformity assessment body’ means a body which performs calibration, testing, certification and inspection activities under                              Article R1(13) in Annex I to Decision No 768/2008/EC of the European Parliament and of the Council(4);                           

‘notified body’ means a conformity assessment body which has been notified by a Member State in accordance with Article 11                              of Directive 90/385/EEC or Article 16 of Directive 93/42/EEC;                           

‘accreditation body’ means the sole body in a Member State that performs accreditation with authority derived from the State                              as laid down by Article 2(10) of Regulation (EC) No 765/2008;                           

‘designating authority’ means the authority(ies) entrusted by a Member State to assess, designate, notify and monitor notified                              bodies under Directive 90/385/EEC or Directive 93/42/EEC;                           

‘competent authority’ means the authority(ies) in charge of market surveillance and/or of vigilance for devices;

‘on-site assessment’ means a verification in the premises of the body or of one of its subcontractors or subsidiaries by the                              designating authority;                           

‘surveillance on-site assessment’ means a periodic routine on-site assessment which is neither the on-site assessment undertaken                              for the initial designation, nor the on-site assessment undertaken for the renewal of the designation;                           

‘observed audit’ means a designating authority's assessment of the performance of a notified body’s audit team in the premises                              of the body's client;                           

‘functions’ means the tasks to be fulfilled by the body’s staff and its external experts, namely: auditing of the quality                              systems, product related technical documentation review, review of clinical evaluations and investigations, device testing                              and, for each of the previously mentioned items, the final review and decision making thereon;                           

‘subcontracting’ means the transfer of tasks to one of the following:

a legal person;

a natural person who further delegates these tasks or parts thereof;

several natural or legal persons who jointly perform these tasks.

## Article 2U.K.Interpretation of designation criteria

The criteria set out in Annex 8 to Directive 90/385/EEC or in Annex XI to Directive 93/42/EEC shall be applied as laid down                     in Annex I.                  

## Article 3U.K.Procedure for the designation of notified bodies

1.When applying for designation as a notified body, a conformity assessment body shall use the application form set out in Annex                        II. If the conformity assessment body submits the application and documents annexed to the application on paper, it shall                        also submit an electronic copy of the application and its annexes.                  

The application shall specify the conformity assessment activities, the conformity assessment procedures and the fields of                     competence for which the conformity assessment body wishes to be notified, the latter by indicating the codes used in the                     ‘New Approach Notified and Designated Organisations’ Information System(5) and subdivisions of those fields.                  

2.The designating authority of the Member State where the conformity assessment body is established shall assess that body in                        accordance with an assessment check-list that covers at least the items listed in Annex II. The assessment shall include an                        on-site assessment.                  

Representatives of designating authorities of two other Member States shall, in coordination with the designating authority                     of the Member State in which the conformity assessment body is established and together with a representative of the Commission,                     participate to the assessment of the conformity assessment body, including the on-site assessment. The designating authority                     of the Member State where the conformity assessment body is established shall give those representatives timely access to                     the documents necessary to assess the conformity assessment body. They shall produce within 45 days after the on-site assessment                     a report, which shall contain at least a summary of identified non-compliances with the criteria set out in Annex I and recommendation                     with regard to the designation of the notified body.                  

3.The Member States shall make available a pool of assessors for the Commission to call upon for each assessment.                  

4.The designating authority of the Member State where the conformity assessment body is established shall upload into a data                        storage system managed by the Commission, the assessment report drafted by the representatives referred to in paragraph 2,                        its own assessment report and, if not contained therein, an on-site assessment report.                  

5.The designating authorities of all the other Member States shall be informed of the application and may request to get access                        to certain or all the documents referred to in paragraph 4. Those authorities and the Commission may review all the documents                        referred to in paragraph 4, may raise questions or concerns and may request further documentation within one month after the                        last upload of one of those documents. Within the same period of time, they may request an exchange of views on the application,                        organised by the Commission.                  

6.The designating authority of the Member State where the conformity assessment body is established shall respond to the questions,                        concerns and requests for further documentation within four weeks following their receipt.                  

The designating authorities of the other Member States or the Commission may individually or jointly address recommendations                     to the designating authority of the Member State where the conformity assessment body is established within four weeks following                     the receipt of the response. That designating authority shall take account of the recommendations when it takes the decision                     on the designation of the conformity assessment body. If it does not follow the recommendations, it shall give the reasons                     therefor within two weeks after its decision.                  

7.The Member State shall notify to the Commission its decision on the designation of a conformity assessment body by means of                        the ‘New Approach Notified and Designated Organisations’ Information System.                  

The validity of the designation shall be limited up to a maximum of five years.

## Article 4U.K.Extension and renewal of designation

1.An extension of the scope of the notified body's designation may be granted in accordance with Article 3.                  

2.A designation as notified body may be renewed in accordance with Article 3 before the end of the validity period of the previous                        designation.                  

3.For the purposes of paragraph 2, the procedure set out in Article 3(2) shall include, where appropriate, an observed audit.                  

4.Extension and renewal procedures may be combined.                  

5.Notified bodies already designated before the entry into force of this Regulation and for which the designation does not have                        a stated validity period or has a validity period exceeding five years, shall be subject to renewal at least within three                        years of entry into force of this Regulation.                  

## Article 5U.K.Surveillance and monitoring

1.For the purpose of surveillance, the designating authority of the Member State where the notified body is established shall                        assess an appropriate number of notified body’s reviews of the manufacturer’s clinical evaluations and shall carry out an                        appropriate number of file reviews, surveillance on-site assessments and observed audits at the following intervals:                  

(a)at least every 12 months for notified bodies with more than 100 clients;                  

(b)at least every 18 months for all other notified bodies.                  

That designating authority shall, in particular, examine changes which have occurred since the last assessment and the work                     the notified body has performed since that assessment.                  

2.Surveillance and monitoring conducted by the designating authorities shall appropriately address subsidiaries.                  

3.The designating authority of the Member State where the notified body is established shall continuously monitor that body                        to ensure ongoing compliance with the applicable requirements. That authority shall provide for a systematic follow-up of                        complaints, vigilance reports and other information, including from other Member States, which might indicate the non-fulfilment                        of the obligations by a notified body or its deviation from common or best practice.                  

In addition to surveillance or renewal on-site assessments, the designating authority of the Member State where the notified                     body is established shall initiate unannounced or short-notice on-site assessments if those on-site assessments are needed                     to verify compliance.                  

## Article 6U.K.Investigation of the competence of a notified body

1.The Commission may investigate cases regarding the competence of a notified body or the fulfilment of the requirements and                        responsibilities to which a notified body is subject under Directive 90/385/EEC and Directive 93/42/EEC.                  

2.Investigations will start with a consultation of the designating authority of the Member State where the notified body is                        established. Upon request, that designating authority shall, within four weeks, provide the Commission with all relevant information                        concerning the relevant notified body.                  

3.The Commission will ensure that all sensitive information obtained in the course of its investigations is treated confidentially.                  

4.When the notified body no longer meets the requirements for its notification, the Commission will inform the Member State                        where that body is established and may request the Member State to take the necessary corrective measures.                  

## Article 7U.K.Exchange of experience on designation and supervision of conformity assessment bodies

1.Designating authorities shall consult each other and the Commission on questions with general relevance with regard to the                        implementation of this Regulation and the interpretation of the provisions of Directive 90/385/EEC and of Directive 93/42/EEC                        in relation with conformity assessment bodies.                  

2.Designating authorities shall communicate to each other and the Commission by 31 December 2013 the model assessment check-list                        used in accordance with Article 3(2) and thereafter the adaptations made to this check-list.                  

3.When the assessment reports referred to in Article 3(4) indicate discrepancies in the general practice of designating authorities,                        Member States or the Commission may request an exchange of views, which will be organised by the latter.                  

## Article 8U.K.Operating of designating authorities

1.Designating authorities shall have a sufficient number of competent personnel at their disposal for the proper performance                        of their tasks. Those authorities shall be established, organised and operated so as to safeguard the objectivity and impartiality                        of their activities and to avoid any conflicts of interests with conformity assessment bodies. The designating authorities                        shall be organised so that each decision relating to a notification of a conformity assessment body is not taken by the same                        member of personnel who carried out the assessment of that body.                  

2.Where designating authorities are not in charge of market surveillance and vigilance for medical devices, they shall involve                        the competent authorities of that Member State for all tasks incumbent to them in accordance with this Regulation. They shall                        in particular consult the competent authorities of that Member State prior to taking decisions and invite them to attend all                        types of assessments.                  

## Article 9U.K.Cooperation with accreditation bodies

Where designation is based on accreditation in the meaning of Regulation (EC) No 765/2008, Member States shall ensure that                     the accreditation body that has accredited a particular notified body is kept informed by the competent authorities on incident                     reports and other information that relate to matters under the control of the notified body when the information may be relevant                     for the assessment of the performance of the notified body. Member States shall ensure that the accreditation body in charge                     of the accreditation of a particular conformity assessment body is kept informed by the designating authority of the Member                     State where the conformity assessment body is established on findings relevant for the accreditation. The accreditation body                     shall inform the designating authority of the Member State where the conformity assessment body is established on its findings.                  

## Article 10U.K.Entry into force and date of application

This Regulation shall enter into force on the twentieth day following that of its publication in the *Official Journal of the European Union*.                  

It shall apply to extension of designations as from 25 December 2013.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 24 September 2013.

*For the Commission*                            

*The President*                            

José Manuel Barroso                            

## ANNEX IU.K.**Interpretation of the criteria set out in Annex 8 to Directive 90/385/EEC and in Annex XI to Directive 93/42/EEC**

### 1.Sections 1 and 5 of Annex 8 to Directive 90/385/EEC and of Annex XI to Directive 93/42/EEC shall be interpreted as including                        the following elements:U.K.

The conformity assessment body shall be a third-party body that is independent of the manufacturer of the product in relation                              to which it performs conformity assessment activities. The conformity assessment body shall also be independent of any other                              economic operator having an interest in the product as well as of any competitor of the manufacturer.                           

That conformity assessment body shall be organised and operated so as to safeguard the independence, objectivity and impartiality                              of its activities. The conformity assessment body shall have procedures in place that effectively ensure identification, investigation                              and resolution of any case in which a conflict of interests may arise, including involvement of its staff in consultancy services                              in the field of medical devices prior to taking up employment with the body.                           

That conformity assessment body, its top management and the personnel responsible for carrying out the conformity assessment                              tasks shall not:                           

engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment                                       activities for which they are notified;                                    

offer or provide any service which may jeopardise the confidence in their independence, impartiality or objectivity. In particular,                                       they shall not offer or provide or have offered or provided, during the last three years, consultancy services to the manufacturer,                                       his authorised representative, a supplier or a commercial competitor as regards Union requirements for the design, construction,                                       marketing or maintenance of the products or processes under assessment. This does not preclude conformity assessment activities                                       for manufacturers and economic operators mentioned above or general training activities relating to medical device regulations                                       or related standards that are not client specific.                                    

The conformity assessment body’s top level management and its assessment personnel shall be impartial. The remuneration of                              the top level management and assessment personnel of a conformity assessment body shall not depend on the number or the results                              of assessments carried out.                           

When a conformity assessment body is owned by a public entity or institution, the Member State shall ensure and document the                              independence of the conformity assessment body and the absence of any conflict of interests between, on the one hand, the                              designating authority and/or competent authority and, on the other hand, the conformity assessment body.                           

The conformity assessment body shall ensure and document that the activities of its subsidiaries or subcontractors, or of                              any associated body, do not affect its independence, impartiality or objectivity in its conformity assessment activities.                           

The requirements of points 1.1 to 1.6 do not preclude exchanges of technical information and regulatory guidance between a                              body and a manufacturer seeking their conformity assessment.                           

### 2.The second paragraph of Section 2 of Annex XI to Directive 93/42/EEC shall be interpreted as including the following elements:U.K.

Subcontracting shall be limited to specific tasks. The subcontracting of the auditing of quality management systems or of                              products related reviews in its entirety is not allowed. The conformity assessment body shall in particular keep internal                              the review of the qualification and the monitoring of the performance of the external experts, the experts’ assignment to                              specific conformity assessment activities, and the final review and decision-making functions.                           

Where a conformity assessment body subcontracts specific tasks or consults external experts related to the conformity assessment,                              it shall have a policy describing the conditions under which subcontracting or the consultation of external experts may take                              place. Any subcontracting or consultation of external experts shall be properly documented and be subject to a written agreement                              covering, among others, confidentiality and conflict of interests.                           

The conformity assessment body shall establish procedures for assessing and monitoring the competence of all subcontractors                              and external experts used.                           

### 3.Sections 3 and 4 of Annex 8 to Directive 90/385/EEC and of Annex XI to Directive 93/42/EEC shall be interpreted as including                        the following elements:U.K.

At all times and for each conformity assessment procedure and each kind or category of products in relation to which it has                              been or wishes to be notified, a conformity assessment body shall have within its organisation the following elements:                           

the necessary administrative, technical, clinical and scientific personnel with technical and scientific knowledge and sufficient                                       and appropriate experience relating to medical devices and the corresponding technologies to perform the conformity assessment                                       tasks, including the assessment of clinical data;                                    

a documented process for the conduct of the conformity assessment procedures for which it is designated(6) taking into account their respective specificities, including legally required consultations, in respect of the different                                       categories of devices covered by the scope of notification, ensuring transparency and the ability of reproduction of those                                       procedures.                                    

The conformity assessment body shall have the necessary personnel and shall possess or have access to all equipment and facilities                              needed to perform properly the technical and administrative tasks entailed in the conformity assessment activities in relation                              to which it has been notified.                           

The conformity assessment body shall have at its disposal the financial resources required to conduct its conformity assessment                              activities and related business operations. It shall document and provide evidence of its financial capacity and its sustainable                              economic viability, taking into account specific circumstances during an initial start-up phase.                           

The conformity assessment body shall have a quality management system in place and operating.

The experience and knowledge of the personnel responsible for carrying out conformity assessment activities shall be interpreted                              as including the following:                           

sound scientific, technical and vocational training, in particular in the relevant fields of medicine, pharmacy, engineering                                       or other relevant sciences, covering all the conformity assessment activities in relation to which the body has been notified                                       or wishes to be notified;                                    

substantial relevant experience covering all the conformity assessment activities in relation to which the body has been notified                                       or wishes to be notified;                                    

satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments;

appropriate knowledge and understanding of the relevant provisions of the medical devices legislation and of the applicable                                       harmonised standards;                                    

the ability to draw up certificates, records and reports demonstrating that assessments have been carried out.

The conformity assessment body shall establish and document qualification criteria and procedures for selection and authorisation                              of persons involved in conformity assessment activities (knowledge, experience and other competence required) and the required                              training (initial and ongoing training). The qualification criteria shall address the various functions within the conformity                              assessment process (e.g. auditing, product evaluation/testing, design dossier/file review, decision-making) as well as the                              devices, technologies and areas (e.g. biocompatibility, sterilisation, tissues and cells of animal origin, clinical evaluation)                              covered by the scope of designation.                           

The conformity assessment body shall have procedures in place to ensure that its subsidiaries operate on the basis of the                              same operating procedures and with the same stringency as its headquarters.                           

Where subcontractors or external experts are used in the context of the conformity assessment, in particular regarding novel,                              invasive and implantable medical devices or technologies, the conformity assessment body shall have adequate internal competence                              in each product area for which it is designated to direct the conformity assessment, to verify the appropriateness and validity                              of expert opinions and make the decision on the certification. The internal competence requested shall cover technological,                              clinical and auditing aspects.                           

### 4.Sections 6 of Annex 8 to Directive 90/385/EEC and of Annex XI to Directive 93/42/EEC shall be interpreted as including the                        following elements:U.K.

The conformity assessment body shall take out appropriate liability insurance corresponding to the conformity assessment activities                              for which it is notified, including the possible suspension, restriction or withdrawal of certificates, and the geographic                              scope of its activities, unless liability is assumed by the State under domestic legislation or the Member State itself carries                              out the inspections directly.                           

### 5.Sections 7 of Annex 8 to Directive 90/385/EEC and of Annex XI to Directive 93/42/EEC shall be interpreted as including the                        following elements:U.K.

The conformity assessment body shall ensure that confidentiality of the information which comes into its possession during                              the performance of the conformity assessment activities is observed by its personnel, committees, subsidiaries, subcontractors                              or any associated body, except when disclosure is required by law. To this end, it shall have documented procedures in place.                           

The personnel of a conformity assessment body shall observe professional secrecy with regard to all information obtained in                              carrying out their tasks, except in relation to the designating authorities and the competent authorities or the Commission.                              Proprietary rights shall be protected. To this end, the conformity assessment body shall have documented procedures in place.                           

## ANNEX IIU.K.**Application form to be submitted when applying for designation as notified body**

Designating authority: ...

Name of the applying conformity assessment body: ...

Previous name (if applicable): ...

EU Notified Body number (if applicable): ...

Address: ...

...

...

...

Contact person: ...

E-mail: ...

Telephone: ...

Legal form of the conformity assessment body: ...

Company registration number: ...

At company register: ...

...

...

The following documents shall be added. In case of extension or renewal, only new or modified documents shall be submitted.

1

OJ L 189, 20.7.1990, p. 17.                           

2

OJ L 169, 12.7.1993, p. 1.                           

3

OJ L 218, 13.8.2008, p. 30.                           

4

OJ L 218, 13.8.2008, p. 82.                           

5

‘NANDO’; see http://ec.europa.eu/enterprise/newapproach/nando

6

See Annex II Item 41.