CELEX: 51988PC0517
Language: en
Date: 1988-09-23
Title: PROPOSAL FOR A COUNCIL REGULATION ( EEC ) EXTENDING THE PROVISIONAL ANTI-DUMPING DUTY IMPOSED ON IMPORTS OF PARACETAMOL ORIGINATING IN THE PEOPLE' S REPUBLIC OF CHINA

No C 14/4                             Official Journal of the European Communities                                  18. 1. 89
                                                             II
                                                     (Preparatory Acts)
                                                COMMISSION
             Proposal for a Council Directive on the approximation of the laws of the Member States
                                 relating to active implantable electromedical equipment
                                              COM(88)    717 final — SYN 173
                                   (Submitted by the Commission on 22 December 1988)
                                                       (89/C 14/05)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                          Whereas, inspection procedures have to be provided,
                                                                  established on the basis of mutual acceptance by the
                                                                  Member States in conformity with Community criteria,
Having regard to the Treaty establishing the European
Economic Community, and in particular Article 100A
                                                                  HAS ADOPTED THIS DIRECTIVE:
thereof,
                                                                                           CHAPTER I
Having regard to the proposal from the Commission,
                                                                                             Article 1
                                                                  1.    This Directive applies to active implantable electro-
In cooperation with the European Parliament.
                                                                  medical devices.
                                                                  2.    For the purpose of this Directive the following defi-
Having regard to the opinion of the Economic and                  nitions shall apply:
Social Committee.
                                                                  — medical device: any instrument, apparatus, implement,
                                                                      substance or other article (used singly or in combi-
Whereas, in each Member State, active implantable elec-               nation) which is intended by the manufacturer for
tromedical devices used in human medicine must meet a                 use in humans for:
high and clearly-defined level of safety both for the users           (a) contraception;
of such equipment and for those receiving treatment by
means of the equipment;                                               (b) diagnosis, prevention, monitoring, treatment or
                                                                           alleviation of disease or injury;
                                                                      (c) investigation or modification of the anatomy or
Whereas several Member States have sought to ensure                        of a physiological process;
that level of safety by mandatory specifications relating             which does not achieve its principal intended action
both to the technical safety regulations and the                      by pharmacological means.
inspection procedures; whereas those specifications differ
from one Member State to another;                                     Software packages which do not form part of an
                                                                      instrument, apparatus, implement or article are
                                                                      excluded from this definition,
Whereas the national provision ensuring such safety level
                                                                  — active implantable electromedical device: any medical
should be harmonized in order to guarantee the free
                                                                      device which is intended to be permanently implanted
market of active implantable electromedical devices
                                                                      within the human body by a surgical operation, such
without lowering existing and justified levels of safety in
                                                                      a device using electricity from an implanted battery
the Member States;
                                                                      or an external source of power, together with
                                                                      non-interchangeable accessories (such as pro-
                                                                      grammers, external power sources) and operating
Whereas the regulations for active implantable electro-               software,
medical devices can be confined to those provisions
needed to satisfy the essential safety requirements:              — permanently       implanted: implantation within the
whereas because they are essential these requirements                 human body for purposes other than for short-term
must replace corresponding national provisions;                       purposes.
 ---pagebreak---  18. 1. 89                             Official Journal of the European Communities                              No C 14/5
                          Article 2                               2.    Member States shall communicate to the
                                                                  Commission the texts of their national standards, as
Member States shall take all necessary steps to ensure            referred to in paragraph 1 (b), which they regard as
that devices referred to in Article 1 (1), hereinafter            complying with the essential safety requirements referred
referred to as 'devices', may be placed on the market and         to in Annex 1. The Commission shall forward such texts
implanted only if they do not impair patients' safety,            forthwith to the Member States. In accordance with the
when properly implanted, maintained and used                     procedure provided for in Article 6 (2), it shall notify the
according to their intended purposes.                             Member States of those national standards in respect of
                                                                 which there is a presumption of conformity with the
                                                                  essential safety requirements referred to in Annex 1.
                          Article 3
The devices referred to in Article 1 (1) shall satisfy the        Member States shall publish the reference numbers of
essential safety requirements set out in Annex 1.                those standards. The Commission shall also publish them
                                                                  in the Official Journal of the European Community.
                          Article 4
                                                                                           Article 6
 1.    Member States shall not impede the placing on the
                                                                  1.    Where a Member State or the Commission
market, the free circulation and the implantation of
                                                                 considers that the harmonized standards referred to in
devices bearing the CE mark.
                                                                 Article 5 (1) do not entirely meet the essential safety
                                                                 requirements referred to in Article 3, the Commission or
                                                                 the Member State concerned shall bring the matter
2.     Member States shall not impede the placing on the         before the Standing Committee set up under Directive
market and the implantation of devices not bearing the            83/189/EEC, hereinafter referred to as 'the committee',
CE mark that are:                                                giving the reasons therefor. The committee shall deliver
                                                                  an opinion without delay.
— intended for clinical evaluation according to the
    procedure of Article 8 (4),                                  In the light of the committee's opinion, the Commission
                                                                 shall inform the Member States whether or not it is
                                                                 necessary to withdraw those standards from the publi-
— of a prototype nature intended for research and                cations referred to in Article 5 (1) (a).
    safety and effectiveness testing.
                                                                 2.     On receipt of the communication referred to in
                                                                 Article 5 (2), the Commission shall consult the
3.     From the date of notification of this Directive,
                                                                 committee. After the committee has given its opinion the
devices may continue, on a transitional basis for a period
                                                                 Commission shall, within a given period, notify the
of three years/ to be placed on the market subject to
                                                                 Member States whether the national standard in question
national provisions already in force on that date,
                                                                 should or should not enjoy presumption of conformity
provided that any such provisions are compatible with
                                                                 and, if so, be subject to national publication of its
the requirements of the Treaty.
                                                                 references.
                          Article 5                              If the Commission or a Member State considers that a
                                                                 national standard no longer fulfils the conditions for
 1.    Member States shall presume compliance with the           presumption of conformity to the safety requirements,
essential safety requirements referred to in Annex 1 in          the Commission shall consult the committee. In the light
respect of devices which are in conformity with:                 of the opinion of the committee, it shall notify the
                                                                 Member States whether or not the standard in question
                                                                 should continue to enjoy presumption of conformity and
(a) the relevant national standards implementing the             in the latter case be withdrawn from the publications
     harmonized standards the references of which have           referred to in Article 5 (2).
     been published in the Official Journal of the European
     Communities; Member States shall publish the
     references of such national standards;                                                Article 7
                                                                 1.     Where a Member State finds that devices bearing
     or with                                                     the CE mark do not satisfy the essential safety
                                                                 requirements when properly implanted and used in
                                                                 accordance with their intended purpose, it shall take all
(b) the relevant national standards referred to in               appropriate measures to withdraw those products from
     paragraph 2 in so far as, in the areas covered by such      the market or to prohibit or restrict their being placed on
     standards, no relevant harmonized standard exists.          the market.
 ---pagebreak--- No C 14/6                             Official Journal of the European Communities                                 18. 1. 89
The Member State concerned shall immediately inform              3.    Devices that are made according to standards
the Commission of any such measure, indicating the              referred to in Article 5 (1) can be subject, as an alter-
reasons for its decision, and in particular whether non         native to the provisions of paragraphs 1 and 2 and at
compliance is due to:                                           manufacturer's choice, to the EC declaration of design
                                                                conformity as described in Annex 2, section 1.
(a) failure to meet the essential safety requirements
     referred to in Article 3, where the device does not        Such a declaration being integrated by the EC
     meet the standards referred to in Article 5 ( 1 ) ;        declaration of production conformity as described in
                                                                Annex 2, section 4.
(b) incorrect application of the standards referred to in
    Article 5 (1);                                              4.     Standards referred to in Article 5 (1) are of two
                                                                different types: technical and clinical; for the latter,
                                                                waiting for the production of a harmonized standard,
(c) shortcomings in the standards referred to in Article 5      devices shall be evaluated clinically according to the
     (1) themselves.                                            provisions of Annex 5.
2.    The Commission shall enter into consultation with          5.   The records and correspondence relating to the
the parties concerned as soon as possible. Where, after         procedures referred to in paragraphs 1, 2 and 3 shall be
such consultation, the Commission finds that any                in an official language of the Member State where the
measure as referred to in paragraph 1 is justified, it shall    said procedures will be carried out, or in a language
immediately so inform the Member State that took the            acceptable to the notified body.
action and the other Member States. Where the decision
referred to in paragraph 1 is attributed to shortcomings
in the standards the Commission, after consulting the                                      Article 9
parties concerned, shall bring the matter before the
                                                                 1.    Member States shall notify to the other Member
Committee within two months if the Member State
                                                                States and the Commission the bodies which they have
which has taken the measures intends to maintain them
                                                                designated for carrying out tasks pertaining to the
and shall initiate the procedures referred to in Article 6.
                                                                procedures referred to in Article 8, the specific tasks for
                                                                which each body has been designated, and the identifi-
3.    Where a device which does not comply bears the            cation codes of the designated bodies.
CE mark the competent Member State shall take appro-
priate action against whomsoever has affixed the mark           The Commission shall publish the list of these notified
and shall inform the Commission and the other Member            bodies, together with the tasks for which they have been
States thereof.                                                 designated, in the Official Journal of the European
                                                                 Communities and shall ensure that the list is kept up to
                                                                date.
4.    The Commission shall ensure that the Member
States are kept informed of the progress and outcome of
this procedure.                                                 2.     Member States shall apply the minimum criteria, set
                                                                out in Annex 4, for the designation of bodies. Bodies
                                                                that satisfy the criteria fixed by the relevant harmonized
                                                                standards shall be presumed to satisfy the criteria set out
                       CHAPTER II                               in Annex 4.
                   Conformity assessment
                                                                3.    A Member State that has designated a body shall
                                                                annul the designation if the body no longer meets the
                         Article 8                              criteria for designation referred to in paragraph 2. It
                                                                shall immediately inform the other Member States and
1.    Devices shall be subject to the EC type examination       the Commission accordingly and withdraw the notifi-
as described in Annex 2, section 2.                             cation.
2.    After having complied with paragraph 1, the manu-
facturer, or his authorized representative established                                  CHAPTER III
within the Community, to be allowed to affix the CE
mark on his devices shall, at his own choice, either:                     CE mark of conformity and inscriptions
(a) apply for EC declaration of production conformity                                     Article 10
    as described in Annex 2, section 4; or
                                                                1.    The CE mark of conformity as referred to in
                                                                Annex 3 shall be affixed to the device where practicable
(b) apply for EC declaration of production conformity           or on the package or on the accompanying documents in
    as described in Annex 2, section 3.                         a clearly visible, easily legible and indelible form.
 ---pagebreak---  18. 1. 89                                  Official Journal of the European Communities                                   No C 14/7
2.     The affixing of marks which are likely to be                                                 CHAPTER IV
confused with the CE mark of conformity shall be
prohibited.                                                                                           Article 12
                                                                           Any decision taken pursuant to this Directive and
                                                                           resulting in restrictions on the placing on the market
                             Article 11                                    and/or taking into service of a device shall state the
                                                                           exact grounds on which it is based. Such decision shall
Where it is established that the CE mark has been                          be notified without delay to the party concerned, who
wrongly affixed to devices because:                                        shall at the same time be informed of the remedies
                                                                           available to him under the laws in force in the Member
                                                                           State in question and of the time limits to which such
— they do not conform to the relevant                   standards
                                                                           remedies are subject.
     referred to in Article 5(1),
                                                                                                      Article 13
— they do not conform to an approved type,
                                                                           1.    Before 1 July 1991, Member States shall adopt and
                                                                           publish the laws, regulations and administrative
    they conform to an approved type which does not                        provisions necessary in order to comply with this
     meet the essential requirements applicable to it,                     Directive. They shall forthwith inform the Commission
                                                                           thereof.
                                                                           They shall apply such provisions from 1 January 1992.
    the manufacturer has failed to fulfil his obligations
     under the relevant EC declaration of production                       2.    Member States shall communicate to the
    conformity,                                                            Commission the texts of the provisions of national law
                                                                           which they adopt in the field covered by this Directive.
the inspection body shall withdraw the EC design
                                                                                                      Article 14
approval certificate or the EC quality systems approval
certificate.                                                               This Directive is addressed to the Member States.
                                                                 ANNEX      1
               ESSENTIAL SAFETY REQUIREMENTS FOR ACTIVE IMPLANTABLE                                    ELECTROMEDICAL
                                                                  DEVICES
               1.      Sterility
                       Patients shall be adequately protected against the risks caused by the use of non-sterile products.
               2.     Clinical evaluation
               2.1.   The clinical conditions of the patient shall not be worsened by the implantation of the device.
               2.2.   Side effects or any undesirable conditions introduced by the device shall not outweight its positive
                      effect.
               3.     Technical evaluation
               3.1.   Protection against misuse
                      The function of such devices shall be laid down in the instructions for use and on the labelling in
                      order to ensure:
               3.1.1. That physicians are fully aware of the potential and limitations of such devices.
              3.1.2. That physicians have sufficient information to make a correct decision about utilization of the
                      device.
              3.1.3. That product parameters and packaging information shall be given in such a way that misinterpre-
                      tations are minimized.
 ---pagebreak--- N o C 14/8                             Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s               18. 1. 89
           3.2.   Protections against hazards arising from the device
                  Measures of a technical nature shall be taken in order to ensure:
           3.2.1. That patients are adequately protected against risk of physical injury which might be caused by
                  product design such as physical and dimensional features together with the biological characteristics
                  of the materials used.
           3.2.2. That patients are adequately protected against power supply depletion by means of a manufacturer's
                  statement with respect to the end of life criteria.
           3.2.3. That patients are adequately protected against the hazards related to the use of electricity such as:
                  (a) poor insulation;
                  (b) excessive leakage currents for the intended use;
                  (c) poor protection of electrical circuits from the risk of contacts with body fluids;
                  (d) excess heat generated by the device;
           3.2.4. Protection against hazards caused by the impossibility of carrying on systematic maintenance and
                  calibration such as:
                  (a) significant deterioration in performance features;
                  (b) excessive increase of leakage currents;
                  (c) degradation of the materials used;
                  (d) ingress of body fluids or leakage of containers;
                  (e) excessive increase of device-generated heat;
           3.2.5. Protection against hazards which might be caused by environmental influences
                  (a) The device shall be designed and manufactured in such a way that mechanical stress which may
                       occur during normal use will not irreversibly degrade its safety;
                  (b) the device shall be manufactured and packed in such a way that it can resist, within the limits
                       set by the manufacturer, to the environment conditions variations (temperature, humidity) that
                       could occur either in normal use and during transport and storage, in such a way that its
                       performance will not be irreversibly degraded, to such a degree that patient's safety is
                       jeopardized;
                  (c) measures shall be adopted in order to reasonably protect the patient in which the device has
                       been implanted, from the hazards arising from electromagnetic fields or from external electrical
                       influences (defibrillators, high frequence surgical equipment, etc.).
                                                                ANNEX      2
                                          CONFORMITY ASSESSMENT PROCEDURE
           1.     EC declaration of design conformity
           1.1.   The EC declaration of design conformity is the process whereby the manufacturer who satisfies the
                  obligations of paragraph 1.2 declares that the design of the type concerned satisfies the requirements
                  of the directive that apply to it.
           1.2.   Obligations
           1.2.1. The manufacturer shall have adequately implemented a quality system for design control that will
                  ensure that design output will meet approved design requirements, and is subject to EC surveillance
                  as specified in paragraph 1.5.
 ---pagebreak--- 18. 1. 89                             Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s               N o C 14/9
          1.2.2. The manufacturer shall make only once the application for the whole quality system covering the
                 provisions of this section and those of section 4 of this Annex, with the exceptions of the provisions
                 of paragraph 1.4, and when new technologies are introduced in the production process, together
                 with a new product.
          1.3.   Quality system
          1.3.1. The manufacturer shall lodge an application for approval of his quality system with a notified body.
                 The application shall include
                 — the quality system's documentation and all other relevant information,
                 — an undertaking to carry out the obligations arising from the quality system as approved,
                 — an undertaking to maintain the approved quality system to ensure its continuing suitability and
                     effectiveness.
          1.3.2. All the elements, requirements and provisions adopted by the manufacturer shall be documented in
                 a systematic and orderly manner in the form of written policies, procedures and instructions. This
                 quality system documentation shall ensure a commom understanding of the quality policies and
                 procedures such as quality programmes, plans, manuals, and records.
                 It shall contain in particular and adequate description of:
                 — the quality objectives, and the organizational structure and responsibilities of management and
                     their powers with regard to design quality,
                 — that design control techniques, processes, and systematic actions that will be used,
                 — the design verification techniques, processes, and systematic actions that will be used, and the
                     frequency with which they will be used,
                 — the means to monitor the achievement of the required design quality and the effective operation
                     of the quality system.
          1.3.3. The notified body shall examine and evaluate the quality system to determine whether it satisfies the
                 requirements referred to in paragraph 1.3.2. It shall presume compliance with these requirements in
                 respect of quality systems that implement the design elements of the corresponding harmonized
                 standard.
                 The notified body shall notify its decision to the manufacturer and inform the other notified bodies
                 thereof. The notification to the manufacturer shall contain the conclusions of the examination and
                 the reasoned assessment decision.
          1.3.4. The manufacturer or his authorized representative established in the Community shall keep the
                 notified body that has approved the quality system informed of any updating of the quality system
                 in relation to changes brought about by, for example, new design technologies and quality concepts.
          1.3.5. A notified body that withdraws approval of a quality system shall so inform the other notified
                 bodies, giving the reasons for the decision.
          1.4.   Design requirements
                 The manufacturer shall establish the design requirements of the type on the basis of the
                 requirements of the directive that apply to it, and submit those to the notified body.
 ---pagebreak--- No C 14/10                               Official Journal of the European Communities                                       18. 1. 89
                  The notified body shall examine and evaluate the design requirements to determine whether they
                  satisfy the relevant requirements of this Directive. It shall notify its decision to the manufacturer and
                  inform the other notified bodies thereof. The notification to the manufacturer shall contain the
                  conclusions of the examination and the reasoned assessment decision.
                  The notified body shall also verify whether the clinical tests have been carried out according to the
                  provisions of Article 8 (4).
           1.5.   EC surveillance
           1.5.1. The purpose of EC surveillance is to make sure that the manufacturer duly fulfils the obligations
                  arising out of the approved quality system.
           1.5.2. The manufacturer shall, upon request, provide all necessary information to the notified body, in
                  particular:
                  — the quality system documentation,
                  — the approved design requirements,
                  — the up to date quality records as foreseen by the quality system, such as results of analyses,
                       calculations, tests, etc.
           1.5.3. The notified body shall make sure that the manufacturer maintains and applies the quality system.
                  It shall provide a surveillance report to the manufacturer.
           2.     EC type examination
           2.1.   The EC type examination is that part of the procedure by which a notified body ascertains and
                  certifies that a product, representative of the production envisaged, meets the provisions of the
                  directive that apply to it.
           2.2.   The application for the type examination shall be lodged by the manufacturer or his authorized
                  representative established within the Community with a single notified body.
                  The application shall include:
                  — the name and address of the manufacturer and, if the application is lodged by the authorized
                       representative, his name and address in addition,
                  — a written declaration that the application has not been lodged with any other notified body,
                  — the design documentation, as described in paragraph 2.3.
                  The applicant shall place at the disposal of the notified body a product, representative of the
                  production envisaged hereinafter called 'type'. The notified body may request further samples of the
                  type if needed by the test programme.
                  A type may additionally cover product variants provided that any modification does not affect the
                  level of safety and other performance requirements of the type.
           2.3.   The design documentation shall contain so far as relevant for assessment:
                  — a general description of the type,
                  — conceptual designs and manufacturing drawings and schemes of components, sub-assemblies,
                       circuits, etc.,
                  — descriptions and explanations necessary for the understanding of the above including the
                       operation of the products,
                  — a list of the standards referred to in Article 5, applied in full or in part and descriptions of the
                       solutions adopted to meet the essential requirements where the standards referred to in Article 5
                       have not been applied,
                  — results of design calculations made and of examinations etc.,
                  — test reports,
                  — a report on clinical tests according to the provisions of Article 8 (4).
 ---pagebreak--- 18. 1. 89                               Official Journal of the European Communities                                     No C 14/11
          2.4.   The notified body shall:
          2.4.1. examine the design document and verify that the type has been manufactured in conformity with
                 the design documentation and identify the elements which have been designed in accordance with
                 the relevant provisions of the standard and the essential requirements of the directive:
          2.4.2. perform or have performed the appropriate examination and/or tests to check whether the solutions
                 adopted by the manufacturer meet the essential requirements where the standards referred to in
                 Article 5 have not been applied;
          2.4.3. perform or have performed the appropriate examinations and/or tests to check whether the relevant
                 standards were effectively applied where the manufacturer has chosen to do so thereby assuring
                 conformity with the essential requirements;
          2.4.4. agree with the applicant the location where the examination and/or tests shall be carried out.
          2.5.   Where the type meets the provisions of the directive the notified body shall issue an EC type
                 approval certificate to the applicant. The certificate shall contain the conclusions of the exam-
                 ination, conditions (if any) for its validity, and the necessary data for identification of the approved
                 type and if relevant description of its functioning. The relevant technical elements such as drawings
                 and schemes shall be annexed to the certificate.
          2.6.   The other notified bodies shall be informed forthwith of the issuing of the EC type approval
                 certificate and its additions referred to in 2.8.2 on the said type. They may obtain a copy of the EC
                 type approval certificate and its additions and on a reasoned request may obtain a copy of the
                 Annexes to the certificate and the reports on the examinations and tests carried out.
          2.7.   A notified body that refuses to issue or withdraws an EC type approval certificate shall so inform
                 the Member State which notified this body and the other notified bodies giving the reasons for the
                  decision.
          2.8.1. The applicant shall keep the notified body that has issued the EC type approval certificate informed
                  of any modification to the approved type.
          2.8.2. Modifications to the approved type must receive additional approval from the notified body that
                  issued the EC type approval certificate where such changes affect the safety of patients when
                  properly implanted, maintained and used according to their intended purpose. This additional
                  approval is given in the form of an addition to the original EC type approval certificate.
          3.      EC declaration of production conformity (type 1)
          3.1.    The EC declaration of production conformity (type 1) is that part of the procedure whereby the
                  manufacturer declares that the products concerned are in conformity with the type as described in
                  the EC type approval certificate and satisfy the requirements of this directive that apply to them.
                  The manufacturer shall affix the CE mark to each product and draw up a written declaration of
                  conformity. The CE mark shall be accompanied by the identification symbol of the notified body
                  responsible for the random checks set out in paragraph 3.3.
          3.2.    The manufacturer shall take all measures necessary in order that the manufacturing process
                  including final product inspection and testing shall ensure homogeneity of production and
                  compliance of the products with the type as described in the EC type approval certificate and with
                  the requirements of the directive that apply to them. A notified body, chosen by the manufacturer,
                  shall carry out random checks on products as set out in either paragraph 3.3. (a) or 3.3. (b) below.
          3.3.    (a) The products shall be subject to statistical control where applicable and shall therefore be
                      grouped into identifiable lots consisting of units of a single model and manufactured under
                       essentially the same conditions. A sample is to be drawn and inspected to determine conformity
                      with the acceptability criteria. The operating characteristics are specified below. In those cases
                      where a batch is rejected the notified body shall take the appropriate measures to prevent the
                      putting on the market of that batch.
 ---pagebreak--- N o C 14/12                              Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s            18. 1. 89
                   (b) On site product checks shall be undertaken at random intervals of one year or less. A sample of
                        the product shall be examined and appropriate tests as set out in the relevant standard(s)
                        referred to in Article 5 or equivalent tests shall be carried out in order to ensure their
                        conformity with the relevant requirements of the directive. In those cases where one of the
                        products under examination does not conform, the notified body shall take measures appro-
                        priate to the nature of the defect(s).
            4.     EC declaration of production conformity (type 2)
            4.1.   The EC declaration of production conformity (type 2) is the procedure whereby the manufacturer
                   who satisfies the obligations of paragraph 2 declares that the products concerned are in conformity
                   with the type as described in the EC type approval certificate and satisfy the requirements of this
                   Directive that apply to them. The manufacturer shall affix the CE mark to each product and draw
                   up a written declaration of conformity. The CE mark shall be accompanied by the identification
                   symbol of the notified body responsible for EEC surveillance.
            4.2.1. The manufacturer shall have adequately implemented a quality system that will ensure compliance
                   of the products with the type as described in the EC type approval certificate or in the EC
                   declaration of design conformity and with the requirement(s) of this directive that apply to them.
                   The manufacturer is subject to EC surveillance as specified in section 4, paragraph 4.
            4.2.2. The manufacturer shall make only once the application for the quality system mentioned in this
                   section, with the exception of the case when new technologies are introduced in the production
                   process in view of a new product.
            4.3.   Quality system
            4.3.1. The manufacturer shall lodge an application for approval of his quality system with a notified body
                   The application shall include:
                   — all relevant information, in particular the quality system's documentation and the design docu-
                       mentation of the approved type,
                   — an undertaking to carry out the obligations arising from the quality system as approved,
                   — an undertaking to maintain the approved quality system to ensure its continuing suitability and
                       effectiveness.
           4.3.2. All the elements, requirements and provisions adopted by the manufacturer shall be documented in
                   a systematic and orderly manner in the form of written policies, procedures and instructions. This
                   quality system documentation shall ensure a common understanding of the quality programmes,
                   plans, manuals, and records.
                   It shall contain in particular an adequate description of:
                   — the quality objectives, and the organizational structure and responsibilities of management and
                       of their powers with regard to product quality,
                   — the manufacturing processes, quality control and quality assurance, techniques and systematic
                       actions that will be used,
                   — the examinations and tests that will be carried out before, during and after manufacture, and the
                       frequency with which they will be carried out,
                   — the means to monitor the achievement of the required product quality and the effective
                       operation of the quality system.
           4.3.3. The notified body shall examine and evaluate the quality system to determine whether is satisfies the
                   requirements referred to in section 3, paragraph 2. It shall presume conformity with these
                   requirements in respect of quality systems that implement the corresponding harmonized standard.
                   It shall notify its decision to the manufacturer and inform the other notified bodies thereof. The
                   notification to the manufacturer shall contain the conclusions of the examination and the reasoned
                   assessment decision.
           4.3.4. The manufacturer or his authorized representative shall keep the notified body that has approved
                   the quality system informed of any updating of the quality system in relation to changes brought
                   about by, for example, new technologies and quality concepts.
 ---pagebreak--- 18. 1. 89                              Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s              N o C 14/13
          4.3.5. A notified body that withdraws approval of a quality system shall so inform the other notified
                 bodies, giving the reasons for the decision.
          4.4.    EC surveillance
          4.4.1. The purpose of EC surveillance is to make sure that the manufacturer duly fulfils the obligations
                  arising out of the approved quality system.
          4.4.2. The manufacturer shall allow the notified body entrance for inspection purposes to the locations of
                  manufacture, inspection and testing, and storage and shall provide it with all necessary information,
                  in particular;
                  — the quality system documentation,
                  — the design documentation,
                  — the quality records, such as inspection reports and test data, calibration data, qualification
                      reports of the personnel concerned, etc.
          4.4.3. The notified body shall make sure that the manufacturer maintains and applies the quality system
                  and shall provide a surveillance report to the manufacturer.
                                                                ANNEX      3
          Devices shall be identified by the manufacturer by means of type, batch or serial numbers.
                                                                ANNEX      4
          MINIMUM CRITERIA T O               BE TAKEN INTO A C C O U N T BY MEMBER                         STATES WHEN
                                             A P P O I N T I N G INSPECTION BODIES
          1. The notified body, its director and the staff responsible for carrying out the verification tests shall not
             be the designer, manufacturer, supplier or installer of apparatus which they inspect, nor the authorized
             representative of any of those parties. They shall not become directly involved in the design,
             construction, marketing or maintenance of the apparatus, nor represent the parties engaged in these
             activities. This does not preclude the possibility of exchanges of technical information between the
             manufacturer and the notified body.
 ---pagebreak--- No C 14/14                              Official Journal of the European Communities                                       18. 1. 89
          2. The notified body and its staff must carry out the verification tests with the highest degree of
              professional integrity and technical competence and must be free from all pressures and inducements,
              particularly financial, which might influence their judgment or the results of the inspection, especially
              from persons or groups of persons with an interest in the result of verifications.
           3. The notified body must have at its disposal the necessary staff and possess the necessary facilities to
              enable it to perform properly the administrative and technical tasks connected with verification; it must
              also have access to the equipment required for special verification.
          4. The staff responsible for inspection must have:
              — sound technical and professional training,
              — satisfactory knowledge of the requirements of the tests they carry out and adequate experience of
                  such tests,
              — the ability to draw up the certificates, records and reports required to authenticate the performance
                  of the tests.
          5. The impartiality of inspection staff must be guaranteed. Their remuneration must not depend on the
              number of tests carried out nor on the results of such tests.
          6. The notified body must take out liability insurance unless its liability is assumed by the State in
              accordance with national law, or the Member State itself is directly responsible for the tests.
          7. The staff of the notified body is bound to observe professional secrecy with regard to all information
              gained in carrying out its tasks (except vis-a-vis the competent administrative authorities of the State in
              which its activities are carried out) under this Directive or any provision of national law giving effect to
              it.
                                                              ANNEX     5
                                                     CLINICAL EVALUATION
          Clinical evaluation can be checked by means of clinical tests performed according to the following points:
           1. Clinical tests shall be performed in a recognized clinical environment specific for the pathologies that
              the device is intended to treat.
          2. Clinical tests shall be performed under the responsibility of a recognized consultant specialist in the
              relevant pathology.
          3. The procedures utilized to perform clinical tests shall be consistent with the device under examination.
          4. Methods to perform the tests shall be consistent with the device under examination.
          5. All appropriate features involving safety of the device shall be examined.