CELEX: 51990FC0385
Language: en
Date: 2006-12-11
Title: Proposal for a Directive …/…/EC of the European Parliament and of the Council of […] on active implantable medical devices (Codified version)

EN

|[pic]                     |COMMISSION OF THE EUROPEAN COMMUNITIES                                                                           |

                                        Brussels,
                                        COM(2005) XXX

                                                                  Proposal for a

                                          DIRECTIVE …/…/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

                                                                      of […]

                                                      on active implantable medical devices

                                                                (Codified version)
                                                              EXPLANATORY MEMORANDUM

1.    In the context of a people’s Europe, the Commission attaches great importance to simplifying and clarifying Community law so as to make  it
       clearer and more accessible to the ordinary citizen, thus giving him new opportunities and the chance to make use of the  specific  rights
       it gives him.

       This aim cannot be achieved so long as numerous provisions that have  been  amended  several  times,  often  quite  substantially,  remain
       scattered, so that they must be sought partly in the original instrument and partly in later amending ones.  Considerable  research  work,
       comparing many different instruments, is thus needed to identify the current rules.

       For this reason a codification of rules that have frequently been amended  is  also  essential  if  Community  law  is  to  be  clear  and
       transparent.

2.    On 1 April 1987 the Commission therefore decided[1] to instruct its staff that all legislative acts should be codified after no  more  than
       ten amendments, stressing that this is a minimum requirement and that departments should endeavour to codify at even shorter intervals the
       texts for which they are responsible, to ensure that the Community rules are clear and readily understandable.

3.    The Conclusions of the Presidency of the Edinburgh  European  Council  (December 1992)  confirmed  this[2],  stressing  the  importance  of
       codification as it offers certainty as to the law applicable to a given matter at a given time.

       Codification must be undertaken in full compliance with the normal Community legislative procedure.

       Given that no changes of substance may be made to the instruments affected by codification, the European Parliament, the Council  and  the
       Commission have agreed, by an interinstitutional agreement dated 20 December 1994, that an accelerated procedure may be used for the fast-
       track adoption of codification instruments.

4.    The purpose of this proposal is to undertake a codification of 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[3].  The  new  Directive  will  supersede  the  various  acts
       incorporated in it[4]; this proposal fully preserves the content of the acts being codified  and  hence  does  no  more  than  bring  them
       together with only such formal amendments as are required by the codification exercise itself.

       5.   The codification proposal was drawn up on the basis  of  a  preliminary  consolidation,  in  all  official  languages,  of  Directive
       90/385/EEC and the instruments amending it, carried out by the Office for Official Publications of the European Communities, by means of a
       data-processing system. Where the Articles have been given new numbers, the correlation between the old and the new numbers is shown in  a
       table contained in Annex XI to the codified Directive.

                                            ê 90/385/EEC (adapted)

                                                                  Proposal for a

                                          DIRECTIVE …/…/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

                                                                      of […]

                                                      on active implantable medical devices

                                                            (Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article Ö 95 Õ thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and Social Committee[5],

Acting in accordance with the procedure laid down in Article 251 of the Treaty[6],

Whereas:

                                            ê .

   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[7] has been substantially amended several times[8]. In the interests of clarity  and  rationality  the  said  Directive  should  be
      codified.

                                            ê 90/385/EEC recital 1

   2) In each Member State active implantable medical devices must give patients, users and other persons a high level of protection and  achieve
      the intended level of performance when implanted in human beings.

                                            ê 90/385/EEC recital 5

   3) Maintaining or improving the level of protection achieved in Member States constitutes one of  this  Directive's  essential  objectives  as
      defined by the essential requirements.

                                            ê 90/385/EEC recital 6 (adapted) and 93/42/EEC recital 8 (adapted)

   4) Ö Harmonized Õ rules governing active implantable medical devices can be confined to those  provisions  needed  to  satisfy  the  essential
      requirements. Because they are essential, these requirements should replace corresponding national provisions. Ö The essential requirements
      should be applied with discretion to take account of the technological level existing at the time of design and of technical  and  economic
      considerations compatible with a high level of protection of health and safety. Õ

                                            ê 90/385/EEC recital 4

   5) Harmonized measures should be distinguished from measures taken by Member States to manage the financing  of  public  health  and  sickness
      insurance schemes directly or indirectly concerning such devices. Therefore, such provisions do not affect the right of  Member  States  to
      implement the abovementioned measures in compliance with Community law.

                                            ê 90/385/EEC recital 7 (adapted)

   6) In order to facilitate proof of conformity with Ö the Õ essential requirements and to permit monitoring of that conformity, it is desirable
      to have Europe-wide harmonized standards in respect of the prevention of risks in connection with the design, manufacture and packaging  of
      active implantable medical devices. Such standards harmonized at European level are drawn up by private-law bodies and should retain  their
      status as non-mandatory texts. To that end, the European Committee for Standardization (CEN), the European Committee  for  Electrotechnical
      Standardization (Cenelec) Ö and the European Telecommunications Standards Institute (ETSI) Õ are recognized as being the  competent  bodies
      to adopt harmonized standards in accordance with the General Guidelines for the cooperation between the Commission Ö and the European  Free
      Trade Association (EFTA) Õ and Ö those three Õ bodies, signed on 28 March 2003.

                                            ê 93/68/EEC recital 3 (adapted)

   7) The two basic elements of the new approach which must be applied are the essential requirements and the conformity assessment procedures.

                                            ê 90/385/EEC recital 8

   8) Evaluation procedures have to be established and accepted by common accord between the Member States in accordance with Community criteria.

                                            ê 93/42/EEC recital 20

   9) The confirmation of complicance with the essential requirements may mean that clinical investigations have to  be  carried  out  under  the
      responsibility of the manufacturer. For the purpose of carrying out the clinical investigations, appropriate means should be specified  for
      the protection of public health and public order.

                                            ê 93/42/EEC recital 16

  10) In cases where the conformity of the devices can be assessed under the responsibility of the manufacturer the competent authorities  should
      be able, particularly in emergencies, to contact a person responsible for  placing  the  device  on  the  market  and  established  in  the
      Community, whether the manufacturer or another person established in the Community and designated by the manufacturer for the purpose.

                                            ê 90/385/EEC recital 9

  11) The specific nature of the medical sector makes it advisable to make provision for the notified body and  the  manufacturer  or  his  agent
      established in the Community to fix, by common accord, the time limits for completion of the evaluation and verification operations for the
      conformity of devices.

                                            ê 93/42/EEC recital 17 (adapted)

  12) Ö Active implantable Õ medical devices should, as a general rule, bear the CE Ö marking Õ to indicate their conformity with the  provisions
      of this Directive to enable them to move freely within the Community and to be put into service in accordance with their intended purpose.

                                            ê .

  13) The measures necessary for the implementation of this Directive should be adopted in accordance with Council  Decision  1999/468/EC  of  28
      June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission[9].

  14) This Directive should be without prejudice to the obligations of the Member States relating  to  the  time-limits  for  transposition  into
      national law and application of the Directives set out in Annex X, Part B,

                                            ê 90/385/EEC

HAVE ADOPTED THIS DIRECTIVE:

                                                                    Article 1

1. This Directive shall apply to active implantable medical devices.

                                            ê 90/385/EEC (adapted)

2. Where an active implantable medical device is intended to administer a substance  defined  as  a  medicinal  product  within  the  meaning  of
Ö Article 1 of Õ Directive Ö 2001/83/EC of the European Parliament and of the Council[10] Õ, that substance shall be subject  to  the  system  of
marketing authorization provided for in that Directive.

                                            ê 90/385/EEC

3. Where an active implantable medical device incorporates, as an integral part, a substance which, if used separately, may be considered  to  be
a medicinal product within the meaning of Article 1 of Directive 2001/83/EC, that device shall be evaluated and  authorized  in  accordance  with
the provisions of this Directive.

4. This Directive constitutes a specific Directive within the meaning of Article 2(2) of Council Directive 89/336/EEC[11].

                                            ê 90/385/EEC Art. 1(2) (adapted)

                                                                  Ö Article 2 Õ

                                            ê 90/385/EEC

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

(a)   ‘medical device’ means any instrument, apparatus, appliance, material or other article, whether used  alone  or  in  combination,  together
       with any accessories or software for its proper functioning, intended by the manufacturer to be used for human beings in the:

              – diagnosis, prevention, monitoring, treatment or alleviation of disease or injury,

              – investigation, replacement or modification of the anatomy or of a physiological process,

              – control of conception,

       and which does not achieve its principal intended action by pharmacological, chemical, immunological or metabolic means, but which may  be
       assisted in its function by such means;

(b)   ‘active medical device’ means any medical device relying for its functioning on a source of electrical energy or any source of power  other
       than that directly generated by the human body or gravity;

(c)   ‘active implantable medical device’ means any active medical device which is intended to be totally or partially introduced, surgically  or
       medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure;

(d)   ‘custom-made device’ means any active implantable medical device specifically made  in  accordance  with  a  medical  specialist's  written
       prescription which gives, under his responsibility, specific design characteristics and is intended to be  used  only  for  an  individual
       named patient;

(e)   ‘device intended for clinical investigation’ means any active implantable medical device intended for  use  by  a  specialist  doctor  when
       conducting investigations in an adequate human clinical environment;

                                            ê 90/385/EEC recital 7, last sentence (adapted)

(f)   ‘harmonized standard’ means a technical specification (European  standard  or  harmonization  document)  adopted  by  either  the  European
       Committee  for  Standardization  (CEN),  the  European  Committee  for  Electrotechnical  Standardization  (Cenelec),  Ö or  the  European
       Telecommunications Standards Institute (ETSI) or jointly by two Õ or Ö all Õ of these bodies, as instructed by the Commission pursuant  to
       the provisions of Directive Ö 98/34/EC of the European Parliament and of the Council Õ[12], and the General Guidelines for the cooperation
       between those bodies and the Commission, signed on 28 March 2003;

                                            ê 90/385/EEC

(g)   ‘intended purpose’ means the use for which the medical device is intended and for which it is suited according to the data supplied by  the
       manufacturer in the instructions;

                                            ê 93/42/EEC Art. 21(3) pt. 1

(h)   ‘manufacturer’ means the natural or legal person with responsibility for the design, manufacture,  packaging  and  labelling  of  a  device
       before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or  on
       his behalf by a third party.

(i)   ‘placing on the market’ means the first making available in return for payment or free of charge of a device other than a  device  intended
       for clinical investigation, with a view to distribution and/or use on the Community market, regardless of  whether  it  is  new  or  fully
       refurbished;

                                            ê 90/385/EEC

(j)   ‘putting into service’ means making available to the medical profession for implantation.

                                            ê 93/42/EEC Art. 21(3) pt. 1 (adapted)

The obligations of this Directive to be met by manufacturers also apply to the natural or legal person who assembles, packages, processes,  fully
refurbishes and/or labels one or more ready-made products and/or assigns to them their intended purpose as a device with a view  to  their  being
placed on the market under his own name. This paragraph does not apply to the person who, while not a manufacturer within the meaning of  Ö point
(h) of Õ the first paragraph, assembles or adapts devices already on the market to their intended purpose for an individual patient.

                                            ê 90/385/EEC

                                                                    Article 3

Member States shall take all necessary steps to ensure that the devices referred to in Article 2(c) and (d) may be placed on the market  and  put
into service only if they do not compromise the safety and health  of  patients,  users  and,  where  applicable,  other  persons  when  properly
implanted, maintained and used in accordance with their intended purposes.

                                                                    Article 4

The active implantable medical devices referred to in Article 2(c), (d) and  (e),  hereinafter  referred  to  as  ‘devices’,  shall  satisfy  the
essential requirements set out in Annex I, which shall apply to them account being taken of the intended purpose of the devices concerned.

                                                                    Article 5

                                            ê 93/68/EEC Art. 9 pt. 2

1. Member States shall not prevent the placing on the market or the putting into service within their territory of  devices  complying  with  the
provisions of this Directive and bearing the CE marking provided for in Article 14  which  indicate  that  they  have  been  the  subject  of  an
evaluation of their conformity in accordance with Article 10.

                                            ê 90/385/EEC
                                            è1 93/68/EEC Art. 9 pt. 1

2. Member States shall not create any obstacles to:

(a)   devices intended for clinical investigations being made available to specialist doctors for that purpose if  they  satisfy  the  conditions
       laid down in Article 12 and in Annex VI;

(b)   custom-made devices being placed on the market and put into service if  they  satisfy  the  conditions  laid  down  in  Annex  VI  and  are
       accompanied by the statement referred to in that Annex.

These devices shall not bear the è1 CE marking ç.

3. At trade fairs, exhibitions, demonstrations, etc., Member States shall not prevent the showing  of  devices  which  do  not  conform  to  this
Directive, provided that a visible sign clearly indicates that such devices do not conform and cannot be put into service until  they  have  been
made to comply by the manufacturer or his authorized representative established within the Community.

4. When a device is put into service, Member States may require the information described in sections 13, 14 and 15 of Annex I  to  be  in  their
national language(s).

                                            ê 93/68/EEC Art. 9 pt. 3

5. Where the devices are subject to other Directives concerning other aspects and which also provide for the affixing  of  the  CE  marking,  the
latter shall indicate that the devices are also presumed to conform to the provisions of the other Directives.

However, where one or more of these Directives allow the manufacturer, during a transitional period, to choose which arrangements to  apply,  the
CE marking shall indicate conformity to the provisions only of those Directives applied by the manufacturer. In this  case,  particulars  of  the
Directives applied, as published in the Official Journal of the European Union,  shall  be  given  in  the  documents,  notices  or  instructions
required by the Directives and accompanying such devices; these  documents,  notices  or  instructions  shall  be  accessible  without  it  being
necessary to destroy the packaging which keeps the device sterile.

                                            ê 90/385/EEC

                                                                    Article 6

Member States shall presume compliance with the essential requirements set out in Annex I in respect of devices which are in conformity with  the
relevant national standards adopted pursuant to the harmonized standards the references of which have been published in the Official  Journal  of
the European Union; Member States shall publish the references of such national standards.

                                                                    Article 7

                                            ê 90/385/EEC (adapted)

1. Where a Member State or the Commission considers that the harmonized standards referred to in Article 6 do not  entirely  meet  the  essential
requirements set out in Annex I, the Commission or the Member State concerned shall bring the matter before the Standing Committee set  up  under
Ö Article 5 of Õ Directive 98/34/EC, hereinafter referred to as ‘the Committee’, giving the reasons therefor.

                                            ê 90/385/EEC

The Committee shall deliver an opinion without delay.

In the light of the opinion of the Committee, the Commission shall inform Member States of the measures to be taken with regard to the  standards
and the publication referred to in Article 6.

                                            ê 1882/2003 Art. 1 and Annex I pt. 2

2. The Commission shall be assisted by the Committee.

                                            ê 1882/2003 Art. 1 and Annex I pt. 2 (adapted)

The Committee may be apprised, in accordance with the procedure referred to in paragraph Ö 3 Õ, of any matter to  which  the  implementation  and
practical application of this Directive give rise.

                                            ê 1882/2003 Art. 1 and Annex I pt. 2

3. Where reference is made to this paragraph, Articles 3 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article  8
thereof.

4. The Committee shall adopt its Rules of Procedure.

                                            ê 90/385/EEC

                                                                    Article 8

1. Where a Member State finds that the devices referred to in Article 2(c) and (d), correctly put into service and used in accordance with  their
intended purpose, may compromise the health and/or safety of patients, users or, where applicable, other persons, it shall take  all  appropriate
measures to withdraw such devices from the market or prohibit or restrict their being placed on the market or their being put into service.

The Member State shall immediately inform the Commission of any such measure, indicating  the  reasons  for  its  decision  and,  in  particular,
whether non-compliance with this Directive is due to:

(a)   failure to meet the essential requirements set out in Annex I, where the device does not meet in full or in part the standards referred  to
       in Article 6;

(b)   incorrect application of those standards;

(c)   shortcomings in the standards themselves.

2. The Commission shall enter into consultation with the parties concerned as soon as possible. Where, after such  consultation,  the  Commission
finds that:

(a)   the measures are justified, it shall immediately so inform the Member State which took the initiative and the other  Member  States;  where
       the decision referred to in paragraph 1 is attributed to shortcomings in the standards, the Commission shall, after consulting the parties
       concerned, bring the matter before the Committee within two months if the Member State which has taken the decision intends to maintain it
       and shall initiate the procedures referred to in Article 7(1);

(b)   the measures are unjustified, it shall immediately so inform the Member State which  took  the  initiative  and  the  manufacturer  or  his
       authorized representative established within the Community.

                                            ê 90/385/EEC (adapted)
                                            è1 93/68/EEC Art. 9 pt. 1

3. Where a device which does not comply bears the è1 CE marking ç, the competent Member State shall take appropriate  action  against  whomsoever
has affixed the Ö marking Õ and shall inform the Commission and the other Member States thereof.

                                            ê 90/385/EEC
                                            è1 93/68/EEC Art. 9 pt. 1

4. The Commission shall ensure that the Member States are kept informed of the progress and outcome of this procedure.

                                                                    Article 9

1. Member States shall take the necessary steps to ensure that information brought to their knowledge regarding  the  incidents  mentioned  below
involving a device is recorded and evaluated in a centralized manner:

(a)   any deterioration in the characteristics and performances of a device, as well as any inaccuracies in the instruction leaflet  which  might
       lead to or might have led to the death of a patient or to a deterioration in his state of health;

(b)   any technical or medical reason resulting in withdrawal of a device from the market by the manufacturer.

2. Member States shall, without prejudice to Article 8, forthwith inform the Commission and the other Member States of the incidents referred  to
in paragraph 1 and of the relevant measures taken or contemplated.

                                                                    Article 10

1. In the case of devices other than those which are custom-made or intended for clinical investigations, the manufacturer  shall,  in  order  to
affix the è1 CE marking ç at his own choice:

(a)   follow the procedure relating to the EC declaration of conformity set out in Annex II; or

(b)   follow the procedure relating to EC type-examination set out in Annex III, coupled with:

       (i)  the procedure relating to EC verification set out in Annex IV, or

       (ii) the procedure relating to the EC declaration of conformity to type set out in Annex V.

2. In the case of custom-made devices, the manufacturer shall draw up the declaration provided for in Annex VI before placing each device on  the
market.

                                            ê 90/385/EEC

3. By derogation from paragraphs 1 and 2 the competent authorities may authorize, on duly justified  request,  the  placing  on  the  market  and
putting into service, within the territory of the Member State concerned,  of  individual  devices  for  which  the  procedures  referred  to  in
paragraphs 1 and 2 have not been carried out and the use of which is in the interest of protection of health.

                                            ê 90/385/EEC

4. Where appropriate, the procedures provided for in Annexes III, IV and VI may be discharged by  the  manufacturer's  authorized  representative
established in the Community.

5. The records and correspondence relating to the procedures referred to in paragraphs 1, 2 and 4 shall be in an official language of the  Member
State in which the said procedures will be carried out and/or in a language acceptable to the notified body defined in Article 13.

                                            ê 93/42/EEC Art. 21(3) pt. 2

6. During the conformity assessment procedure for a device, the manufacturer and/or the notified body shall take account of the  results  of  any
assessment and verification operations which, where appropriate, have been carried out in accordance  with  this  Directive  at  an  intermediate
stage of manufacture.

7. Where the conformity assessment procedure involves the intervention of a notified body, the manufacturer,  or  his  authorized  representative
established in the Community, may apply to a body of his choice within the framework of the tasks for which the body has been notified.

8. The notified body may require, where duly justified, any information  or  data  which  is  necessary  for  establishing  and  maintaining  the
attestation of conformity in view of the chosen procedure.

9. Decisions taken by the notified bodies in accordance with Annexes II and III shall be valid for a maximum of five years and  may  be  extended
on application, made at a time agreed in the contract signed by both parties, for further periods of five years.

                                            ê 93/42/EEC Art. 21(3) pt. 3

                                                                    Article 11

1. Where a Member State considers that the conformity of a device or family of devices should be established,  by  way  of  derogation  from  the
provisions of Article 10, by applying solely one of the given procedures chosen from among those referred to in Article 10,  it  shall  submit  a
duly substantiated request to the Commission and ask it to take the necessary measures. These measures shall be adopted in  accordance  with  the
procedure referred to in Article 7(2) of Council Directive 93/42/EEC[13].

2. The Commission shall inform the Member States of the measures taken and, where appropriate, publish the relevant parts of  these  measures  in
the Official Journal of the European Union.

                                            ê 90/385/EEC

                                                                    Article 12

1. In the case of devices intended for clinical investigations, the manufacturer or his authorized representative established  in  the  Community
shall, at least 60 days before the commencement of the investigations, submit the statement referred to in Annex VI to the competent  authorities
of the Member State in which the investigations are to be conducted.

2. The manufacturer may commence the relevant clinical investigations at the end of a period of 60 days after notification, unless the  competent
authorities have notified him within that period of a decision to the contrary, based on considerations of public health or public order.

                                            ê 93/42/EEC Art. 21(3) pt. 4

Member States may however authorize manufacturers to start the clinical investigations in question  before  the  expiry  of  the  60-day  period,
provided that the Ethical Committee concerned has delivered a favourable opinion with respect to the investigation programme in question.

3. The authorization referred to in the second subparagraph of paragraph 2 may be subject to approval by the competent authority.

                                            ê 90/385/EEC

4. The Member States shall, if necessary, take the appropriate steps to ensure public health and order.

                                                                    Article 13

                                            ê 93/68/EEC Art. 9 pt. 4

1. Member States shall notify the Commission and the other Member State of the approved bodies  which  they  have  appointed  to  carry  out  the
procedures referred to in Article 10 together with the specific tasks which these bodies have been appointed to carry out and the  identification
numbers assigned to them beforehand by the Commission.

The Commission shall publish in the Official Journal of the European Union a list of the notified bodies and with  their  identification  numbers
and the tasks for which they have been notified. The Commission shall ensure that this list is kept up to date.

                                            ê 90/385/EEC

2. Member States shall apply the minimum criteria, set out in Annex VIII, for the designation of bodies. Bodies that satisfy the  criteria  fixed
by the relevant harmonized standards shall be presumed to satisfy the relevant minimum criteria.

3. A Member State that has notified a body shall withdraw that notification if it finds that the body no longer meets the  criteria  set  out  in
Annex VIII. It shall immediately inform the other Member States and the Commission thereof.

4. The notified body and the manufacturer or his agent established in the Community shall fix, by common accord, the time limits  for  completion
of the evaluation and verification operations referred to in Annexes II to V.

                                                                    Article 14

                                            ê 90/385/EEC
                                            è1 93/68/EEC Art. 9 pt. 1

1. Devices other than those which are custom made or intended for clinical investigations considered to meet the essential requirements  set  out
in Annex I shall bear the è1 CE marking ç of conformity.

2. The è1 CE marking ç of conformity, as shown in Annex IX, shall appear in a visible, legible and indelible form on the sterile pack and,  where
appropriate, on the sales packaging, if any, and on the instruction leaflet.

                                            ê 93/68/EEC Art. 9 pt. 5

It shall be followed by the identification number of the notified body responsible for implementation of the procedures set out  in  Annexes  II,
IV and V.

                                            ê 93/68/EEC Art. 9 pt. 6

3. The affixing of markings on the devices which are likely to deceive third parties as to the meaning and  form  of  the  CE  marking  shall  be
prohibited. Any other marking may be affixed to the packaging or to the instruction leaflet accompanying the device provided that the  visibility
and legibility of the CE marking is not hereby reduced.

                                            ê 93/68/EEC Art. 9 pt. 7

                                                                    Article 15

Without prejudice to Article 8:

(a)   where a Member State establishes that the  CE  marking  has  been  affixed  unduly,  the  manufacturer  or  his  authorized  representative
       established within the Community shall be obliged to end the infringement under conditions imposed by the Member State;

(b)   where non-compliance continues, the Member State shall take all appropriate measures to restrict or prohibit the placing on the  market  of
       the device in question or to ensure that it is withdrawn from the market in accordance with the procedures laid down in Article 8.

                                            ê 90/385/EEC

                                                                    Article 16

Any decision taken pursuant to this Directive and resulting in the refusal of or restrictions on the placing on the market  and/or  putting  into
service of a device shall state the exact grounds on which it is based. Such decision shall be notified without delay  to  the  party  concerned,
who 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 remedies are subject.

                                            ê 93/42/EEC Art. 21(3) pt. 5

In the event of a decision as referred to in the  first  paragraph  the  manufacturer,  or  his  authorized  representative  established  in  the
Community, shall have an opportunity to put forward his viewpoint in advance, unless such consultation is not possible because of the urgency  of
the measures to be taken.

                                            ê 90/385/EEC

                                                                    Article 17

Member States shall ensure that all the parties involved in the application of this Directive are bound to observe  confidentiality  with  regard
to all information obtained in carrying out their tasks. This does not affect the obligations of Member States and notified  bodies  with  regard
to mutual information and the dissemination of warnings.

                                                                    Article 18

                                            ê 90/385/EEC (adapted)

Member States shall communicate to the Commission the texts of the provisions of national law which they adopt  in  the  field  covered  by  this
Directive.

                                            ê .

                                                                    Article 19

Directive 90/385/EEC, as amended by the Acts listed in Annex X, Part A, is repealed, without prejudice to the obligations of  the  Member  States
relating to the time-limits for transposition into national law and application of the Directives set out in Annex X, Part B.

References to the repealed Directive shall be construed as references to this Directive and shall be read  in  accordance  with  the  correlation
table in Annex XI.

                                                                    Article 20

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

                                            ê 90/385/EEC

                                                                    Article 21

This Directive is addressed to the Member States.

Done at Brussels, […]

For the European Parliament  For the Council
The President    The President
[…]   […]

                                            ê 90/385/EEC

                                                                     ANNEX I

                                                              ESSENTIAL REQUIREMENTS

I.    GENERAL REQUIREMENTS

1.    The devices shall be designed and manufactured in such a way that, when implanted under the conditions and  for  the  purposes  laid  down,
       their use does not compromise the clinical condition or the safety of patients. They shall not present any risk to the persons  implanting
       them or, where applicable, to other persons.

2.    The devices shall achieve the performances intended by the manufacturer, viz. be designed and manufactured in such  a  way  that  they  are
       suitable for one or more of the functions referred to in Article 2(a) as specified by him.

3.    The characteristics and performances referred to in sections 1 and 2 shall not be adversely affected to such a  degree  that  the  clinical
       condition and safety of the patients or, as appropriate, of other persons are compromised during the lifetime of the device anticipated by
       the manufacturer, where the device is subjected to stresses which may occur during normal conditions of use.

4.    The devices shall be designed, manufactured and packed in such a  way  that  their  characteristics  and  performances  are  not  adversely
       affected in the storage and transport conditions laid down by the manufacturer (temperature, humidity, etc.).

5.    Any side effects or undesirable conditions shall constitute acceptable risks when weighed against the performances intended.

II.   REQUIREMENTS REGARDING DESIGN AND CONSTRUCTION

6.    The solutions adopted by the manufacturer for the design and construction of  the  devices  shall  comply  with  safety  principles  taking
       account of the generally acknowledged state of the art.

7.    Implantable devices shall be designed, manufactured and packed in a non-reusable pack according to appropriate procedures  to  ensure  they
       are sterile when placed on the market and, in the storage and transport conditions stipulated by the manufacturer,  remain  so  until  the
       packaging is removed and they are implanted.

8.    Devices shall be designed and manufactured in such a way as to remove or minimize as far as possible:

         – the risk of physical injury in connection with their physical, including dimensional, features,

         – risks connected with the use of energy sources with particular reference, where electricity is used, to insulation, leakage  currents
           and overheating of the devices,

         – risks connected with reasonably foreseeable environmental  conditions  such  as  magnetic  fields,  external  electrical  influences,
           electrostatic discharge, pressure or variations in pressure and acceleration,

         – risks connected with medical treatment, in particular those resulting from the  use  of  defibrillators  or  high-frequency  surgical
           equipment,

                                            ê 90/385/EEC (adapted)

         – risks connected with ionizing radiation from radioactive substances included  in  the  device,  in  compliance  with  the  protection
           requirements laid down in Council Directives Ö 96/29/Euratom Õ[14] and Ö 97/43/Euratom Õ[15],

                                            ê 90/385/EEC

         – 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.

9.    The devices shall be designed and manufactured in such a way as to guarantee  the  characteristics  and  performances  referred  to  in  I.
       ‘General requirements’, with particular attention being paid to:

         – the choice of materials used, particularly as regards toxicity aspects,

         – mutual compatibility between the materials used  and  biological  tissues,  cells  and  body  fluids,  account  being  taken  of  the
           anticipated use of the device,

         – compatibility of the devices with the substances they are intended to administer,

         – the quality of the connections, particularly in respect of safety,

         – the reliability of the source of energy,

         – if appropriate, that they are leakproof,

         – proper functioning of the programming and control systems, including software.

                                            ê 90/385/EEC (adapted)

10.   Where a device incorporates, as an integral part, a substance which, when used separately, is likely to be considered  to  be  a  medicinal
       product as defined in Article  1  of  Directive  2001/83/EC,  and  whose  action  in  combination  with  the  device  may  result  in  its
       bioavailability, the safety, quality and usefulness of the substance, account being taken of the purpose of the device, shall be  verified
       by analogy with the appropriate methods specified in Ö that Õ Directive.

                                            ê 90/385/EEC
                                            è1 93/68/EEC Art. 9 pt. 1

11.   The devices and, if appropriate, their component parts shall be identified to allow  any  necessary  measure  to  be  taken  following  the
       discovery of a potential risk in connection with the devices and their component parts.

12.   Devices shall bear a code by which they and their manufacturer can be unequivocally identified (particularly with regard  to  the  type  of
       device and year of manufacture); it shall be possible to read this code, if necessary, without the need for a surgical operation.

13.   When a device or its accessories bear instructions  required  for  the  operation  of  the  device  or  indicate  operating  or  adjustment
       parameters, by means of a visual system, such information shall be understandable to the user and, as appropriate, the patient.

14.   Every device shall bear, legibly and indelibly, the following particulars, where appropriate in the form of generally recognized symbols:

14.1. on the sterile pack:

         – the method of sterilization,

         – an indication permitting this packaging to be recognized as such,

         – the name and address of the manufacturer,

         – a description of the device,

         – if the device is intended for clinical investigations, the words: ‘exclusively for clinical investigations’,

         – if the device is custom-made, the words ‘custom-made device’,

         – a declaration that the implantable device is in a sterile condition,

         – the month and year of manufacture,

         – an indication of the time limit for implanting a device safely;

14.2. on the sales packaging:

         – the name and address of the manufacturer,

         – a description of the device,

         – the purpose of the device,

         – the relevant characteristics for its use,

         – if the device is intended for clinical investigations, the words: ‘exclusively for clinical investigations’,

         – if the device is custom-made, the words: ‘custom-made device’,

         – a declaration that the implantable device is in a sterile condition,

         – the month and year of manufacture,

         – an indication of the time limit for implanting a device safely,

         – the conditions for transporting and staring the device.

15.   When placed on the market, each device shall be accompanied by instructions for use giving the following particulars:

         – the year of authorization to affix the è1 CE marking ç,

         – the details referred to in sections 14.1 and 14.2, with the exception of those referred to in the eighth and ninth indents,

         – the performances referred to in section 2 and any undesirable side effects,

         – information allowing the physician to select a suitable device and the corresponding software and accessories,

         – information constituting the instructions for use allowing the physician and, where appropriate, the patient to use the  device,  its
           accessories and software correctly, as well as information on the nature, scope and times for  operating  controls  and  trials  and,
           where appropriate, maintenance measures,

         – information allowing, if appropriate, certain risks in connection with implantation of the device to be avoided,

         – information regarding the risks of reciprocal interference[16] in  connection  with  the  presence  of  the  device  during  specific
           investigations or treatment,

         – the necessary instructions in the event of the sterile pack being damaged and, where appropriate, details of appropriate  methods  of
           resterilization,

         – 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 essential requirements.

       The instruction leaflet shall also include details allowing the  physician  to  brief  the  patient  on  the  contra-indications  and  the
       precautions to be taken. These details should cover in particular:

         – information allowing the lifetime of the energy source to be established,

         – precautions to be taken should changes occur in the device's performance,

         – precautions to be taken as regards exposure, in  reasonably  foreseeable  environmental  conditions,  to  magnetic  fields,  external
           electrical influences, electrostatic discharge, pressure or variations in pressure, acceleration, etc.,

         – adequate information regarding the medicinal products which the device in question is designed to administer.

16.   Confirmation that the device satisfies the requirements in respect of characteristics and performances,  as  referred  to  in  I.  ‘General
       requirements’, in normal conditions of use, and the evaluation of the side effects or undesirable effects shall be based on clinical  data
       established in accordance with Annex VII.

                                                                    __________

                                            ê 90/385/EEC

                                                                     ANNEX II

                                                           EC DECLARATION OF CONFORMITY

                                                       (Complete quality assurance system)

1.    The manufacturer shall apply the quality system approved for the design, manufacture and final inspection  of  the  products  concerned  as
       specified in sections 3 and 4 and shall be subject to EC surveillance as specified in section 5.

2.    The declaration of conformity is the procedure by means of which the manufacturer who satisfies the obligations of section  1  ensures  and
       declares that the products concerned meet the provisions of this Directive which apply to them.

                                            ê 93/68/EEC Art. 9 pt. 8(a)

       The manufacturer or his authorized representative established within the Community shall affix the CE marking in accordance  with  Article
       14 and shall draw up a written declaration of conformity.

       This declaration shall cover one or more identified examples of the product and shall be  kept  by  the  manufacturer  or  his  authorized
       representative established within the Community.

       The CE marking shall be accompanied by the identification number of the notified body responsible.

                                            ê 90/385/EEC

3.    Quality system

3.1.  The manufacturer shall make an application for evaluation of his quality system to a notified body.

       The application shall include:

         – all the appropriate items of information for the category of products manufacture of which is envisaged,

         – the quality-system documentation,

         – an undertaking to fulfil the obligations arising from the quality system as approved,

         – an undertaking to maintain the approved quality system in such a way that it remains adequate and efficacious,

         – an undertaking by the manufacturer to institute and keep  up-dated  a  post-marketing  surveillance  system.  The  undertaking  shall
           include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning  of
           them:

           (i)   any deterioration in the characteristics or performances, and any inaccuracies in the instruction leaflet for  a  device  which
                might lead to or have led to the death of a patient or a deterioration in his state of health;

           (ii)  any technical or medical reason resulting in withdrawal of a device from the market by the manufacturer.

3.2.  The application of the quality system shall ensure that the products conform to the provisions of this Directive which  apply  to  them  at
       every stage, from design to final controls.

       All the elements, requirements and provisions adopted by the manufacturer for his quality system shall be documented in a  systematic  and
       orderly manner in the form of  written  policies  and  procedures.  This  quality-system  documentation  shall  make  possible  a  uniform
       interpretation of the quality policies and procedures such as quality programmes, quality plans, quality manuals and quality records.

       It shall include in particular an adequate description of:

       (a)  the manufacturer's quality objectives;

       (b)  the organization of the business and in particular:

              – the organizational structures, the responsibilities of the managerial staff and their organizational authority where  quality  of
                design and manufacture of the products is concerned,

              – the methods of monitoring the efficient operation of the quality system and in particular its  ability  to  achieve  the  desired
                quality of the design and of the products, including control of products which do not conform;

       (c)  the procedures for monitoring and verifying the design of the products and in particular:

              – the design specifications, including the standards which will be applied and a description of the  solutions  adopted  to  fulfil
                the essential requirements which apply to the products when the standards referred to in Article 6 are not applied in full,

              – the techniques of control and verification of the design, the processes and systematic  actions  which  will  be  used  when  the
                products are being designed;

       (d)  the techniques of control and of quality assurance at the manufacturing stage and in particular:

              – the processes and procedures which will be used, particularly as regards sterilization, purchasing and the relevant documents,

              – product-identification procedures drawn up and kept up to date from drawings,  specifications  or  other  relevant  documents  at
                every stage of manufacture;

       (e)  the appropriate tests and trials which will be effected before, during and after production, the frequency with which they will  take
           place, and the test equipment used.

3.3.  Without prejudice to Article 15 , the notified body shall effect an audit  of  the  quality  system  to  determine  whether  it  meets  the
       requirements referred to in section 3.2. It shall presume conformity with these  requirements  for  the  quality  systems  which  use  the
       corresponding harmonized standards.

       The team entrusted with the evaluation shall include at least one member who has already had experience of evaluations of  the  technology
       concerned. The evaluation procedure shall include an inspection on the manufacturer's premises.

       The decision shall be notified to the manufacturer after the final inspection. It shall contain the  conclusions  of  the  control  and  a
       reasoned evaluation.

3.4.  The manufacturer shall inform the notified body which has approved the quality system of any plan to alter the quality system.

       The notified body shall evaluate the proposed modifications and shall verify whether  the  quality  system  so  modified  would  meet  the
       requirements referred to in section 3.2; it shall notify the manufacturer of its decision. This decision shall contain the conclusions  of
       the control and a reasoned evaluation.

4.    Examination of the design of the product

4.1.  In addition to the obligations incumbent on him under section 3, the manufacturer shall make an application for examination of  the  design
       dossier relating to the product which he plans to manufacture and which falls into the category referred to in section 3.1.

4.2.  The application shall describe the design, manufacture, and performances of the  product  in  question  and  shall  include  the  necessary
       particulars which make it possible to evaluate whether it complies with the requirements of this Directive.

       It shall include inter alia:

         – the design specifications, including the standards which have been applied,

         – the necessary proof of their appropriations, in particular where the standards referred to in Article 6  have  not  been  applied  in
           full. This proof shall include the results of the appropriate tests carried  out  by  the  manufacturer  or  carried  out  under  his
           responsibility,

         – a statement as to whether or not the device incorporates, as an integral part, a substance as referred to in section 10 of  Annex  I,
           whose action in combination with the device may result in its bioavailability, together with data on the relevant trials conducted,

         – the clinical data referred to in Annex VII,

         – the draft instruction leaflet.

4.3.  The notified body shall examine the application and, where the product complies with the  relevant  provisions  of  this  Directive,  shall
       issue the applicant with an EC design examination certificate. The notified body may require the application to be supplemented by further
       tests or proof so that compliance with the requirements of the Directive may be evaluated. The certificate shall contain  the  conclusions
       of the examination, the conditions of its validity, the data needed for identification of the approved design and,  where  appropriate,  a
       description of the intended use of the product.

4.4.  The applicant shall inform the notified body which issued the EC design examination certificate of any modification made  to  the  approved
       design. Modifications made to the approved design shall obtain supplementary approval from the notified body which issued  the  EC  design
       examination certificate where such modifications may affect conformity with the essential requirements of this Directive or the conditions
       prescribed for the use of the product. This supplementary approval shall be given in the form of an addendum to the EC design  examination
       certificate.

5.    Surveillance

5.1.  The aim of surveillance is to ensure that the manufacturer duly fulfils the obligations arising from the approved quality system.

5.2.  The manufacturer shall authorize the notified body to carry out all  necessary  inspections  and  shall  supply  it  with  all  appropriate
       information, in particular:

         – the quality-system documentation,

         – the data stipulated in the part of the quality system relating to design, such as  the  results  of  analyses,  calculations,  tests,
           etc.,

         – the data stipulated in the part of the quality system relating  to  manufacture,  such  as  reports  concerning  inspections,  tests,
           standardizations/calibrations and the qualifications of the staff concerned, etc.

5.3.  The notified body shall periodically carry out appropriate inspections and evaluations in order  to  ascertain  that  the  manufacturer  is
       applying the approved quality system, and shall supply the manufacturer with an evaluation report.

5.4.  In addition, the notified body may make unannounced visits to the manufacturer, and shall supply him with an inspection report.

                                            ê 93/68/EEC Art. 9 pt. 8(b)

6.    Administrative provisions

6.1.  For at least five years from last date of manufacture of the product, the manufacturer shall keep available for the national authorities:

         – the declaration of conformity,

         – the documentation referred to in the second indent of section 3.1,

         – the amendments referred to in section 3.4,

         – the documentation referred to in section 4.2,

         – the decisions and reports of the notified body referred to in sections 3.4, 4.3, 5.3 and 5.4.

6.2.  On request, the notified body shall make available to the other notified bodies and the competent authority  all  relevant  information  on
       approvals of quality systems issued, refused or withdrawn.

                                            ê 93/68/EEC Art. 9 pt. 8(b) (adapted)

6.3.  Where neither the manufacturer nor his authorized representative are established in the Community, the task of keeping  available  for  the
       authorities the technical documentation referred to in Ö section 4.2 Õ shall fall to the person responsible for placing the  appliance  on
       the Community market.

                                                                    __________

                                            ê 90/385/EEC

                                                                    ANNEX III

                                                               EC TYPE-EXAMINATION

1.    EC type-examination is the procedure whereby a notified body observes  and  certifies  that  a  representative  sample  of  the  production
       envisaged satisfies the relevant provisions of this Directive.

2.    The application for EC type-examination shall be made by  the  manufacturer,  or  by  his  authorized  representative  established  in  the
       Community, to a notified body.

       The application shall include:

         – the name and address of the manufacturer and the name and address of the authorized representative if the application is made by  the
           latter,

         – a written declaration specifying that an application has not been made to any other notified body,

         – the documentation described in section 3 needed to allow an evaluation to be made of the conformity of  a  representative  sample  of
           the production in question, hereinafter referred to as ‘type’, with the requirements of this Directive.

       The applicant shall make a ‘type’ available to the notified body. The notified body may request other samples as necessary.

3.    The documentation shall make it possible to understand the design, the manufacture and the performances of the product.  The  documentation
       shall contain the following items in particular:

         – a general description of the type,

         – design drawings, methods of manufacture envisaged, in particular as regards sterilization, and  diagrams  of  parts,  sub-assemblies,
           circuits, etc.,

         – the descriptions and explanations necessary for the understanding of the abovementioned drawings and diagrams and  of  the  operation
           of the product,

         – a list of the standards referred to in Article 6, applied in full or in part, and a description of the solutions adopted  to  satisfy
           the essential requirements where the standards referred to in Article 6 have not been applied,

         – the results of design calculations, investigations and technical tests carried out, etc.,

         – a statement as to whether or not the device incorporates, as an integral part, a substance as referred to in section 10 of  Annex  I,
           whose action in combination with the device may result in its bioavailability, together with data on the relevant trials conducted,

         – the clinical data referred to in Annex VII,

         – the draft instruction leaflet.

4.    The notified body shall:

4.1.  examine and evaluate the documentation, verify that the type has been manufactured in accordance with that  documentation;  it  shall  also
       record the items which have been designed in accordance with the applicable provisions of the standards referred to in Article 6, as  well
       as the items for which the design is not based on the relevant provisions of the said standards;

4.2.  carry out or have carried out the appropriate inspections and  the  tests  necessary  to  verify  whether  the  solutions  adopted  by  the
       manufacturer satisfy the essential requirements of this Directive where the standards referred to in Article 6 have not been applied;

4.3.  carry out or have carried out the appropriate inspections and the tests necessary to verify whether, where the manufacturer has  chosen  to
       apply the relevant standards, these have actually been applied;

4.4.  agree with the applicant on the place where the necessary inspections and tests will be carried out.

5.    Where the type meets the provisions of this Directive, the notified body shall issue an EC type-examination certificate to  the  applicant.
       The certificate shall contain the name and address of the manufacturer, the conclusions of the control, the  conditions  under  which  the
       certificate is valid and the information necessary for identification of the type approved.

       The significant parts of the documentation shall be attached to the certificate and a copy shall be kept by the notified body.

6.    The applicant shall inform the notified body which issued the EC type-examination certificate of any  modification  made  to  the  approved
       product.

       Modifications to the approved product shall receive further  approval  from  the  notified  body  which  issued  the  EC  type-examination
       certificate where such modifications may affect conformity with the essential requirements or with the conditions of use specified for the
       product. This new approval shall be issued, where appropriate, in the form of a supplement to the initial EC type-examination certificate.

                                            ê 93/68/EEC Art. 9 pt. 9

7.    Administrative provisions

7.1.  On request, each notified body shall make available to the other notified bodies and the competent authority, all relevant  information  on
       EC type-examination certificates and addenda issued, refused or withdrawn.

7.2.  Other notified bodies may obtain a copy of  the  EC  type-examination  certificates  and/or  the  addenda  to  them.  The  annexes  to  the
       certificates shall be made available to the other notified bodies when a reasoned application is made and after the manufacturer has  been
       informed.

7.3.  The manufacturer or his authorized representative  shall  keep  with  the  technical  documentation  a  copy  of  the  EC  type-examination
       certificates and the supplements to them for a period of at least five years from the manufacture of the last appliance.

7.4.  Where neither the manufacturer nor his authorized representative are established in the  Community,  the  task  of  keeping  the  technical
       documentation available for the authorities shall fall to the person responsible for placing the  appliance  concerned  on  the  Community
       market.

                                                                    __________

                                            ê 93/68/EEC Art. 9 pt. 10

                                                                     ANNEX IV

                                                                 EC VERIFICATION

1.    EC verification is the procedure whereby the manufacturer or his authorized representative established within  the  Community  ensures  and
       declares that the products subject to the provisions of section 3 are in conformity with the type as described in the EC  type-examination
       certification and satisfy the requirements of this Directive that apply to them.

2.    The manufacturer or his authorized representative established within the Community shall take all measures  necessary  in  order  that  the
       manufacturing process ensures conformity of the products to the type as described in the EC  type-examination  certification  and  to  the
       requirements of this Directive that apply to them. The manufacturer or his authorized  representative  established  within  the  Community
       shall affix the CE marking to each product and draw up a written declaration of conformity.

3.    The manufacturer shall, before the start of manufacture, prepare documents defining the manufacturing processes, in particular  as  regards
       sterilization, together with all the routine, pre-established provisions  to  be  implemented  to  ensure  uniformity  of  production  and
       conformity of the products with the type as described in the EC type-examination certificate as well as with the relevant requirements  of
       this Directive.

4.    The manufacturer shall undertake to institute and keep updated a post-marketing surveillance system. This  undertaking  shall  include  the
       obligation on the part of the manufacturer to notify the competent authorities of the following events immediately on learning of them:

       (i)  any change in the characteristics or performances and any inaccuracies in the instruction leaflet for a device which might lead to or
           have led to the death of a patient or deterioration in his state of health;

       (ii) any technical or medical reason resulting in the withdrawal of a device from the market by a manufacturer.

5.    The notified body shall carry out the appropriate examinations and  tests  in  order  to  check  the  conformity  of  the  product  to  the
       requirements of this Directive by examination and testing of products on a statistical basis, as specified in section 6. The  manufacturer
       shall authorize the notified body to evaluate the efficiency of the measures taken pursuant to section 3, by audit where appropriate.

6.    Statistical verification

6.1.  Manufacturers shall present the products manufactured in the form of uniform batches and shall take all necessary measures  in  order  that
       the manufacturing process ensures the uniformity of each batch produced.

6.2.  A random sample shall be taken from each batch. Products in a sample shall be individually examined and appropriate tests, as  set  out  in
       the standard(s) referred to in Article 6, or equivalent tests shall be carried out to verify their conformity to the type as described  in
       the EC type-examination certificate and thereby determine whether a batch is to be accepted or rejected.

6.3.  Statistical control of products shall be based on attributes, entailing a sampling system with the following characteristics:

         – a level of quality corresponding to a probability of acceptance of 95 %, with a non-conformity percentage of between 0,29 and 1 %,

         – a limit quality corresponding to a probability of acceptance of 5 %, with a percentage of non-conformity of between 3 and 7 %.

6.4.  Where batches are accepted, the notified body shall affix, or cause to be affixed, its identification number to each product and draw up  a
       written certificate of conformity relating to the tests carried out. All products in the batch may be placed  on  the  market  except  for
       those products from the sample which were found not to be in conformity.

       Where a batch is rejected, the notified body shall take appropriate measures to prevent the placing on the market of that  batch.  In  the
       event of frequent rejection of batches the notified body may suspend the statistical verification.

       The manufacturer may, under the responsibility of the notified body, affix the latter's identification  number  during  the  manufacturing
       process.

6.5.  The manufacturer or his authorized representative shall ensure that he is able to supply the notified body's certificates of conformity  on
       request.

                                                                    __________

                                            ê 90/385/EEC

                                                                     ANNEX V

                                                       EC DECLARATION OF CONFORMITY TO TYPE

                                                        (Assurance of production quality)

1.    The manufacturer shall apply the quality system approved for the manufacture and  shall  conduct  the  final  inspection  of  the  products
       concerned as specified in section 3; he shall be subject to the surveillance referred to in section 4.

2.    This declaration of conformity is the procedural element whereby the manufacturer who satisfies the obligations  of  section  1  guarantees
       and declares that the products concerned conform to the type described in the EC type-examination certificate and meet the  provisions  of
       the Directive which apply to them.

                                            ê 93/68/EEC Art. 9 pt. 11

       The manufacturer or his authorized representative established within the Community shall affix the CE marking in accordance  with  Article
       14 and draw up a written declaration of conformity. This declaration shall cover one or more identified specimens of the product and shall
       be kept by the manufacturer. The CE marking shall be accompanied by the identification number of the notified body responsible.

                                            ê 90/385/EEC

3.    Quality system

3.1.  The manufacturer shall make an application for evaluation of his quality system to a notified body.

       The application shall include:

         – all appropriate information concerning the products which it is intended to manufacture,

         – the quality-system documentation,

         – an undertaking to fulfil the obligations arising from the quality system as approved,

         – an undertaking to maintain the approved quality system in such a way that it remains adequate and efficacious,

         – where appropriate, the technical documentation relating to the approved type and a copy of the EC type-examination certificate,

         – an undertaking by the manufacturer to institute and keep  up-dated  a  post-marketing  surveillance  system.  The  undertaking  shall
           include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning  of
           them:

           (i)   any deterioration in the characteristics or performances, and any inaccuracies in the instruction leaflet for  a  device  which
                might lead to or have led to the death of a patient or a deterioration in his state of health;

           (ii)  any technical or medical reason resulting in withdrawal of a device from the market by the manufacturer.

3.2.  Application of the quality system shall ensure that the products conform to the type described in the EC type-examination certificate.

       All the elements, requirements and provisions adopted by the manufacturer for his quality system shall be documented in a  systematic  and
       orderly manner in the form of  written  policies  and  procedures.  This  quality-system  documentation  shall  make  possible  a  uniform
       interpretation of the quality policies and procedures such as quality programmes, quality plans, quality manuals and quality records.

       It shall include in particular an adequate description of:

       (a)  the manufacturer's quality objectives;

       (b)  the organization of the business and in particular:

              – the organizational structures, the responsibilities of the managerial staff and their organizational authority where  manufacture
                of the products is concerned,

              – the methods of monitoring the efficient operation of the quality system and in particular its  ability  to  achieve  the  desired
                quality of the products, including control of products which do not conform;

       (c)  the techniques of control and of quality assurance at the manufacturing stage and in particular:

              – the processes and procedures which will be used, particularly as regards sterilization, purchasing and the relevant documents,

              – product identification procedures drawn up and kept up-to-date from drawings,  specifications  or  other  relevant  documents  at
                every stage of manufacture;

       (d)  the appropriate tests and trials which will be effected before, during and after production, the frequency with which they will  take
           place, and the test equipment used.

3.3.  Without prejudice to Article 15, the notified body shall effect an  audit  of  the  quality  system  to  determine  whether  it  meets  the
       requirements referred to in section 3.2. It shall presume conformity with these  requirements  for  the  quality  systems  which  use  the
       corresponding harmonized standards.

       The team entrusted with the evaluation shall include at least one member who has already had experience of evaluations of  the  technology
       concerned. The evaluation procedure shall include an inspection on the manufacturer's premises.

       The decision shall be notified to the manufacturer after the final inspection. It shall contain the  conclusions  of  the  control  and  a
       reasoned evaluation.

3.4.  The manufacturer shall inform the notified body which has approved the quality system of any plan to alter that system.

       The notified body shall evaluate the proposed modifications and shall verify whether  the  quality  system  so  modified  would  meet  the
       requirements referred to in section 3.2; it shall notify the manufacturer of its decision. This decision shall contain the conclusions  of
       the control and a reasoned evaluation.

4.    Surveillance

4.1.  The aim of surveillance is to ensure that the manufacturer duly fulfils the obligations which arise from the approved quality system.

4.2.  The manufacturer shall authorize the notified body to carry out all  necessary  inspections  and  shall  supply  it  with  all  appropriate
       information, in particular:

         – the quality-system documentation,

         – the data stipulated in the part of the quality system relating  to  manufacture,  such  as  reports  concerning  inspections,  tests,
           standardizations/calibrations and the qualifications of the staff concerned, etc.

4.3.  The notified body shall periodically carry out appropriate inspections and evaluations in order  to  ascertain  that  the  manufacturer  is
       applying the approved quality system, and shall supply the manufacturer with an evaluation report.

4.4.  In addition, the notified body may make unannounced visits to the manufacturer, and shall supply him with an inspection report.

5.    The notified body shall communicate to the other notified bodies all relevant information concerning approvals of quality  systems  issued,
       refused or withdrawn.

                                                                    __________

                                            ê 90/385/EEC

                                                                     ANNEX VI

                                            STATEMENT CONCERNING DEVICES INTENDED FOR SPECIAL PURPOSES

1.    The manufacturer or his authorized representative established within the Community shall draw up for custom-made  devices  or  for  devices
       intended for clinical investigations the statement comprising the elements stipulated in section 2.

2.    The statement shall comprise the following information:

2.1.  for custom-made devices:

         – data allowing the device in question to be identified,

         – a statement affirming that the device is intended for exclusive use by a particular patient, together with his name,

         – the name of the doctor who drew up the prescription and, if applicable, the name of the clinic concerned,

         – the particular features of the device as described by the medical prescription concerned,

         – a statement affirming that the device complies with the essential requirements given in Annex I  and,  where  applicable,  indicating
           which essential requirements have not been wholly met, together with the grounds;

2.2.  for devices intended for clinical investigations covered in Annex VII:

         – data allowing the devices in question to be identified,

         – an investigation plan giving in particular the purpose, scope and number of the devices concerned,

         – the name of the doctor and of the institution responsible for the investigations,

         – the place, date of commencement and duration scheduled for the investigations,

         – a statement affirming that the device in question complies with the essential requirements apart from the  aspects  constituting  the
           object of the investigations and that, with regard to these aspects, every precaution has been taken to protect the health and safety
           of the patient.

3.    The manufacturer shall undertake to keep available for the competent national authorities:

3.1.  for custom-made devices, documentation  enabling  the  design,  manufacture  and  performances  of  the  product,  including  the  expected
       performances, to be understood, so as to allow conformity with the requirement of this Directive to be assessed.

       The manufacturer shall take all necessary measures to see that the manufacturing process ensures that the products manufactured conform to
       the documentation referred to in the first paragraph;

3.2.  for devices intended for clinical investigations, the documentation shall also contain:

         – a general description of the product,

         – design drawings, manufacturing methods, in particular as regards sterilization, and  diagrams  of  parts,  sub-assemblies,  circuits,
           etc.,

         – the descriptions and explanations necessary for the understanding of the said drawings and diagrams  and  of  the  operation  of  the
           product,

         – a list of the standards laid down in Article 6, applied in full or in part, and a description of the  solutions  adopted  to  satisfy
           the essential requirements of the Directive where the standards in Article 6 have not been applied,

         – the results of the design calculations, checks and technical tests carried out, etc.

       The manufacturer shall take all necessary measures to see that the manufacturing process ensures that the products manufactured conform to
       the documentation referred to in section 3.1 and in the first paragraph of this section.

       The manufacturer may authorize the evaluation, by audit where necessary, of the effectiveness of these measures.

                                                                    __________

                                            ê 90/385/EEC

                                                                    ANNEX VII

                                                               CLINICAL EVALUATION

1.    General provisions

1.1.  Adequacy of the clinical data presented, as referred to in section 4.2 of Annex II, and in section 3 of Annex III, shall be based,  account
       being taken as appropriate of the relevant harmonized standards, on either:

1.1.1.      a collation of currently available relevant scientific literature covering  the  intended  use  of  the  device  and  the  techniques
       therefor, as well as, if appropriate, a written report making a critical assessment of this collation; or

1.1.2.      the results of all clinical investigations made, including those carried out in accordance with section 2.

1.2.  All data shall remain confidential unless it is deemed essential that they be divulged.

2.    Clinical investigation

2.1.  Purpose

       The purpose of clinical investigation is to:

         – verify that, under normal conditions of use, the performances of the device comply with those indicated in section 2 of Annex I,

         – determine any undesirable side effects, under normal conditions of use, and assess whether they are acceptable  risks  having  regard
           to the intended performance of the device.

2.2.  Ethical consideration

                                            ê 90/385/EEC (adapted)

       Clinical investigations shall be made in accordance with the Declaration of Helsinki Ö adopted Õ by the 18th  World  Medical  Assembly  in
       Helsinki, Finland, in 1964. It is mandatory that all measures relating to the protection of human subjects are carried out in  the  spirit
       of the Declaration of Helsinki. This includes every step in the clinical investigation from first consideration of need and  justification
       of the study to publication of results.

                                            ê 90/385/EEC

2.3.  Methods

2.3.1.      Clinical investigations shall be performed according to an appropriate state of the art plan of investigation defined in such  a  way
       as to confirm or refute the manufacturer's claims for the device; the investigations shall include an adequate number of  observations  to
       guarantee the scientific validity of the conclusions.

2.3.2.      The procedures utilized to perform the investigations shall be appropriate to the device under examination.

2.3.3.      Clinical investigations shall be performed in circumstances equivalent to those which would be found in normal conditions of  use  of
       the device.

2.3.4.      All appropriate features, including those involving the safety and performances of the device,  and  its  effects  on  the  patients,
       shall be examined.

2.3.5.      All adverse events shall be fully recorded.

2.3.6.      The investigations shall be performed under the responsibility of an appropriately qualified medical specialist,  in  an  appropriate
       environment.

       The medical specialist shall have access to the technical data regarding the device.

2.3.7.      The written report, signed by the responsible medical specialist, shall comprise a critical evaluation  of  all  the  data  collected
       during the clinical investigation.

                                                                    __________

                                            ê 90/385/EEC

                                                                    ANNEX VIII

                                   MINIMUM CRITERIA TO BE MET WHEN DESIGNATING INSPECTION BODIES TO BE NOTIFIED

1.    The body, its director and the staff responsible for carrying out the evaluation and verification operations shall  not  be  the  designer,
       manufacturer, supplier or installer of devices which they control, nor the authorized representative of any of those parties. They may not
       become directly involved in the design, construction, marketing or maintenance of the devices, nor represent the parties engaged in  these
       activities. This does not preclude the possibility of exchanges of technical information between the manufacturer and the body.

2.    The body and its staff shall carry out the evaluation and verification operations with the highest degree  of  professional  integrity  and
       technical competence and shall be free from all pressures and inducements, particularly financial, which might influence  their  judgement
       or the results of the inspection, especially from persons or groups of persons with an interest in the results of verifications.

3.    The body shall be able to carry out all the tasks in one of Annexes II to V assigned to such a body and for which  it  has  been  notified,
       whether those tasks are carried out by the body itself or under its responsibility. In particular, it  shall  have  at  its  disposal  the
       necessary staff and possess the necessary facilities to enable it to perform properly the technical  and  administrative  tasks  connected
       with evaluation and verification; it shall also have access to the equipment necessary for the verifications required.

4.    The staff responsible for control operations shall have:

         – sound vocational training covering all the evaluation and verification operations for which the body has been designated,

         – satisfactory knowledge of the requirements of the controls they carry out and adequate experience of such operations,

         – the ability required to draw up the certificates, records and reports to demonstrate that the controls have been carried out.

5.    The impartiality of inspection staff shall be guaranteed. Their remuneration shall not depend on the number of controls  carried  out,  nor
       on the results of such controls.

6.    The body shall take out liability insurance unless liability is assumed by the State in accordance with national law, or the  Member  State
       itself is directly responsible for controls.

7.    The staff of the body are bound to observe professional secrecy with regard to all information gained in carrying out their  tasks  (except
       vis-à-vis the competent administrative authorities of the State in which their activities are carried out) under  this  Directive  or  any
       provision of national law giving effect to it.

                                                                    __________

                                            ê 93/68/EEC Art. 9 pt. 12

                                                                     ANNEX IX

                                                              CE CONFORMITY MARKING

     – The CE conformity marking shall consist of the initials ‘CE’ taking the following form:

                                                                      [pic]

     – If the CE marking is reduced or enlarged the proportions given in the above graduated drawing shall be respected.

     – 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.

                                                                    __________

                                            é

                                                                     ANNEX X

                                                                      Part A

                                                Repealed Directive with its successive amendments
                                                           (referred to in Article 19)

|Council Directive 90/385/EEC                                                                     |                                        |
|(OJ L 189, 20.7.1990, p. 17)                                                                     |                                        |
|Council Directive 93/42/EEC                                                                 |only Article 21(3)                      |
|(OJ L 169, 12.7.1993, p. 1)                                                                 |                                        |
|Council Directive 93/68/EEC                                                                 |only Article 9                          |
|(OJ L 220, 30.8.1993, p. 1)                                                                 |                                        |
|Regulation (EC) No 1882/2003 of the European Parliament and of the Council                  |only Annex I, point 2)                  |
|(OJ L 284, 31.10.2003, p. 1)                                                                |                                        |

                                                                      Part B

                                     List of time-limits for transposition into national law and application
                                                           (referred to in Article 20)

|Directive                                     |Time-limit for transposition                  |Date of application                           |
|90/385/EEC                                    |30 June 1992                                  |1 January 1993(1)                             |
|93/42/EEC                                     |1 July 1994                                   |1 January 1995(2)                             |
|93/68/EEC                                     |30 June 1994                                  |1 January 1995(3)                             |

_______________________

(1)   In conformity with Article 16(3) of Directive 90/385/EEC: “Member States shall, for the period up to 31 December 1994, permit  the  placing
       on the market and putting into service of devices complying with national rules in force in their territory on 31 December 1992.”
(2)   In conformity with Article 22(4) of Directive 93/42/EEC: “Member States shall accept:
       - devices which conform to the rules in force in their territory on 31 December 1994 being placed on the market during a  period  of  five
       years following the adoption of this Directive, and
       - the aforementioned devices being put into service until 30 June 2001 at the latest.

       In the case of devices which have been subjected to EEC pattern approval in accordance with  Directive  76/764/EEC,  Member  States  shall
       accept their being placed on the market and put into service during the period up to 30 June 2004.”
(3)   In conformity with Article 14(2) of Directive 93/68/EEC: “Until 1 January 1997 Member States shall allow the placing on the market and  the
       bringing into service of products which comply with the marking arrangements in force before 1 January 1995.”
                                                                  _____________
                                                                     ANNEX XI

                                                                Correlation Table

|Directive 90/385/EEC                                                 |This Directive                                                       |
|Recital 7, last sentence                                             |Article 2(f)                                                         |
|Article 1(1)                                                         |Article 1(1)                                                         |
|Article 1(2), introductory words                                     |Article 2, first paragraph, introductory words                       |
|Article 1(2)(a) to (e)                                               |Article 2, first paragraph (a) to (e)                                |
|Article 1(2)(f)                                                      |Article 2, first paragraph (g)                                       |
|Article 1(2)(g)                                                      |Article 2, first paragraph (j)                                       |
|Article 1(2)(h)                                                      |Article 2, first paragraph (i)                                       |
|Article 1(2)(i), first subparagraph                                  |Article 2, first paragraph (h)                                       |
|Article 1(2)(i), second subparagraph                                 |Article 2, second paragraph                                          |
|Article 1(3)                                                         |Article 1(2)                                                         |
|Article 1(4)                                                         |Article 1(3)                                                         |
|Article 1(5)                                                         |Article 1(4)                                                         |
|Article 2                                                            |Article 3                                                            |
|Article 3                                                            |Article 4                                                            |
|Article 4(1)                                                         |Article 5(1)                                                         |
|Article 4(2), first subparagraph introductory words                  |Article 5(2), first subparagraph introductory words                  |
|Article 4(2), first subparagraph first indent                        |Article 5(2), first subparagraph, (a)                                |
|Article 4(2), first subparagraph second indent                       |Article 5(2), first subparagraph, (b)                                |
|Article 4(2), second subparagraph                                    |Article 5(2), second subparagraph                                    |
|Article 4(3)                                                         |Article 5(3)                                                         |
|Article 4(4)                                                         |Article 5(4)                                                         |
|Article 4(5)(a)                                                      |Article 5(5), first subparagraph                                     |
|Article 4(5)(b)                                                      |Article 5(5), second subparagraph                                    |
|Article 5                                                            |Article 6                                                            |
|Article 6(1), first subparagraph first sentence                      |Article 7(1), first subparagraph                                     |
|Article 6(1), first subparagraph second sentence                     |Article 7(1), second subparagraph                                    |
|Article 6(1), second subparagraph                                    |Article 7(1), third subparagraph                                     |
|Article 6(2), first subparagraph                                     |Article 7(2), first subparagraph                                     |
|Article 6(2), second subparagraph                                    |Article 7(2), second subparagraph                                    |
|Article 6(2), third subparagraph                                     |Article 7(3)                                                         |
|Article 6(2), fourth subparagraph                                    |Article 7(4)                                                         |
|Article 7(1)                                                         |Article 8(1)                                                         |
|Article 7(2), introductory wording                                   |Article 8(2), introductory wording                                   |
|Article 7(2), first indent                                           |Article 8(2)(a)                                                      |
|Article 7(2), second indent                                          |Article 8(2)(b)                                                      |
|Article 7(3)                                                         |Article 8(3)                                                         |
|Article 7(4)                                                         |Article 8(4)                                                         |
|Article 8                                                            |Article 9                                                            |
|Article 9(1)                                                         |Article 10(1)                                                        |
|Article 9(2)                                                         |Article 10(2)                                                        |
|Article 9(3)                                                         |Article 10(4)                                                        |
|Article 9(4)                                                         |Article 10(5)                                                        |
|Article 9(5)                                                         |Article 10(6)                                                        |
|Article 9(6)                                                         |Article 10(7)                                                        |
|Article 9(7)                                                         |Article 10(8)                                                        |
|Article 9(8)                                                         |Article 10(9)                                                        |
|Article 9(9)                                                         |Article 10(3)                                                        |
|Article 9a                                                           |Article 11                                                           |
|Article 10(1)                                                        |Article 12(1)                                                        |
|Article 10(2)                                                        |Article 12(2)                                                        |
|Article 10(2a)                                                       |Article 12(3)                                                        |
|Article 10(3)                                                        |Article 12(4)                                                        |
|Article 11                                                           |Article 13                                                           |
|Article 12                                                           |Article 14                                                           |
|Article 13                                                           |Article 15                                                           |
|Article 14                                                           |Article 16                                                           |
|Article 15                                                           |Article 17                                                           |
|Article 16(1)                                                        |_____                                                                |
|Article 16(2)                                                        |Article 18                                                           |
|Article 16(3)                                                        |_____                                                                |
|_____                                                                |Article 19                                                           |
|_____                                                                |Article 20                                                           |
|Article 17                                                           |Article 21                                                           |
|Annexes I to IX                                                      |Annexes I to IX                                                      |
|_____                                                                |Annex X                                                              |
|_____                                                                |Annex XI                                                             |

                                                                  _____________

                                                             -----------------------
[1]   COM(87) 868 PV.
[2]   See Annex 3 to Part A of the Conclusions.
[3]   Carried out pursuant to the Communication from the Commission to the European Parliament and the  Council  –  Codification  of  the  Acquis
      communautaire, COM(2001) 645 final.
[4]   See Annex X, Part A of this proposal.
[5]   OJ C […], […], p. […].
[6]   OJ C […], […], p. […].
[7]   OJ L 189, 20.7.1990, p. 17. Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council  (OJ  L
      284, 31.10.2003, p. 1).
[8]   See Annex X, Part A.
[9]   OJ L 184, 17.7.1999, p. 23.
[10]  OJ L 311, 28.11.2001, p. 67.
[11]  OJ L 139, 23. 5. 1989, p. 19.
[12]  OJ L 204, 21.7.1998, p.37.
[13]  OJ L 169, 12. 7. 1993, p. 1.
[14]  OJ L 159, 29.6.1996, p. 1.
[15]  OJ L 180, 9.7.1997, p. 22.
[16]  ‘Risks of reciprocal interference’ means adverse effects on the device caused by instruments present  at  the  time  of  investigations  or
      treatment, and vice versa.