CELEX: 51988PC0717
Language: en
Date: 1988-12-12
Title: Proposal for a COUNCIL DIRECTIVE on the approximation of the laws of the Member States relating to active implantable electromedical equipment. (presented by the Commission)

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 ---pagebreak---     COMMISSION    OF THE EUROPEAN COMMUNITIES
                                                          COM ( 88 ) 717 final SYN 173
                                                          Brussels , 12  December 1988
                            Proposai for a v
                           COUNCIL DIRECTIVE
            on the approximation of the laws of the
            Member States relating to active implantable
            electromedical equipment .
                   ( presented by the Commission )
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              Active implantadle electromedical equipment (ATEME)
                              Explanatory mémorandum
I.    General
l.    Scope
      This proposal for a Directive has been produced pursuant to the
      Council Resolution of 7 May 1985 on a new approach, to technical
      harmonization and standards^) . It forms part of the programme of
      work laid down in the White Paper on the completion of the internal
      market by the end of 1992 .
      It applies to the safety of active implantable electromedical
      equipment , hereinafter referred to as " implants ", i.e. electromedical
      equipment for therapeutic or diagnostic purposes permanently implanted
      in the human body by means of a surgical operation and using an
      electrical energy source consisting of a battery which is also
      implanted or located outside the body . The cardiac stimulator is the
      best known example of this kind of equipment , which consists of the
      following major subdivisions :
      a)  cardiac stimulation :
               simple impulse generators
               complex impulse generators
               antitachycardiac devices
      b)  defibrill ation
      c) the implantable artificial heart
( 1 ) OJ C 136 , 4.6.1985 , p. 1 .
                                                                              £
 ---pagebreak---                                     - 2 -
     d)  biostimulation :
             of the nervous system
             of the vascular system
             of the ear
             of the diaphragm
             of the bladder
             of the skeletal system
             of the peripheral muscles
             other forms
    e ) input of an active substance
             with or without a closed loop
             sensors
    f ) active implantable organs
    g ) others , in particular :
             implantable monitoring devices .
    In view in particular of the energy source whib they use , implants
    are a special category of electromedical equipment justifying the
    preparation of a specific Directive to harmonise the national
    regulations on their safety and manufacture . The Directive therefore
    serves two purposes : the introduction of Community legislation on
    patient safety and the removal of the barriers to trade arising from
    the differences between the national regulations .
 2.
    Before starting work on the preparation of the proposal , the
    Commission conducted a detailed survey to examine the national
    regulations in the field of electromedical equipment in general aid.
    implants in particular .
3
 ---pagebreak---                                 - 3 -
The findings of the survey confirmed, that there are major differences
between the Member States , not only as regards the technical
specifications on the design of electromedical equipment , but also as
regards the administrative procedures for the examinations , tests ,
inspections aid. authorizations required for the marketing , use and
implantation of implants .
One of the features of this sector and a justification for .harmonizing
the national regulations concerned is the degree of risk posed by
implants and the different approaches adopted by the Member States as
regards the means of protection of patients against such potential
risks .
The national regulations on implants often , for traditional reasons ,
form part of the more general provisions applicable to medical
equipment and pharmaceutical products and do not always take full
account of an important feature in the field of implants , i.e. the
fast rate of innovation resulting from medical research .
Broadly speaking , there are two different approaches in the Community
as regards the various means of ensuring patient safety . On the one
hand , there are systems in which major importance is attached to
inspection of equipment before it is placed on trie market by means of
type approval and/or certi ification procedures and , on the other- hand ,
there is the approach which on the whole consists of verifying that
firms are able to guarantee a constant level of product safety , this
mainly taking the form of " good-manufacturing practice " (GMP ) or other
quality assurance systems .
These differences in approach are due to different concepts of safety
and for this reason it is inevitable that recourse to Article 10QA of
the EEC Treaty will have to be made to abolish the technical barriers
to trade which, will inevitably arise in view of the nature of the
products concerned .
                                                                           h
 ---pagebreak---                                - 4 -
 In conformity with Article 10QA , paragraph 3 . this proposal contains
 the necessary provisions in order to guarantee a high level of
protection to the patients and other concerned categories .
The role and importance of national standards is clearly inversely
proportional to that of intervention in the form of regul ations .
European standards are more or less non-existent .
It is clearly very difficult to assess the direct economic impact of
such harriers and to calculate the cost . Economic analysis would make
it possible to evaluate the additional costs which exporting companies
would incur as a result of " non-harmonization " , but would not
necessarily shed light on any other adverse consequences .
However , the development of the internal market cannot be seen solely
in macroeconomic terms of overall growth as a function of turnover in
the sector alone . It must also be seen from the two angles of
technological dynamism and the improvement of living conditions in the
Community . The economic and social aspects are therefore closely
interlinked and must be taken into consideration within the framework
of an integrated approach .
It is thus particularly important that harmonization in the field of
implants should proceed in a manner which expedites marketing as far
as possible while offering the patient the maximum guarantee in terms
of safety . In this way , the rapid distribution of high-technology
products will benefit both industry , in which the rate of innovation
will thus be increased , and the patient , who will benefit from an
improvement in his health and a prolonged active life without having
to wait for the most advanced equipment .
6
 ---pagebreak---                                        - 5 -
3.    Consultation of the parties concerned
      From the beginning of the preparatory work , the Commission 's concern
      has been to involve a 1 1 the parties concerned , that is to say
      government representatives , manufacturers , doctors specialized in
      implantation techniques and representatives of the European standards
      bodies CEN and CENELEC .
                                                                    i
      The gain objective of the consultation procedure has been to try to
      find the best possible solutions and to keep , as far as possible , to
      the spirit and the letter of the Council Resolution of 7 May 1985 ,
      while taking account of the specific requirements of a relatively
      narrow and specific field of application and of the complexity of the
      various safety aspects .
4.    T.inks with other harmonization systems
4.1 .      Harmonization in the field of electromedical equipment began with
           the adoption of Council Directive 84/ 539/EEC .
           This Directive , which, was prepared in the conventional manner ,
           refers to a world standard , IEC Publication 601-1 , which is
           endorsed by CENELEC and which lays down in a detailed manner the
           general safety requirements for all electromedical equipment . The
           specific requirements that may have to be laid down for certain
           specific categories of equipment are determined by other standards
           based on the above standard . The scope of Directive 84/ 539/EEC
           has been confined to those categories of equipment for which
           conformity with IEC standard 601-1 and the general requirements it
           lays down was considered to be sufficient to guarantee the safety
           of the patient and the users of such equipment .
                                                                             Ο
 ---pagebreak---                                   - 6 -
4.2 . This draft concerns a category of equipment which is to some
      extent on the fringe of electromedical equipment as a whole . The
      first difference concerns the energy source which , in the case of
      implants , will nearly always be an electric cell contained within
      the equipment itself , whereas all other medical equipment ,
      including the equipment covered by Directive 84/ 539/EEC , operates
      on the main power supply system or a similar power source .
      The second major difference is that implants are by definition
      introduced into the human body , in particular in order to regulate
      the vital functions .
      The very low-voltage energy source and the invasive character of
      implants therefore mean that very specific safety considerations
      will be required and these will be reflected in standards which
      will not necessarily be subordinate to IEC Publication 601-1 .
      The safety requirements will , on the other hand , also have to take
      account of aspects not associated with the use of electricity ,
      such as sterility , biocompatibility and operational reliability .
4.3 . Other categories of medical equipment which are not covered either
      by Directive 84/ 539/ EEC or by this draft are the subject of
      preparatory work which is being carried out in close cooperation
      with the parties concerned .
4.4 . Harmonization of non-electrical medical equipment has been the
      subject of preparatory contacts with the parties concerned .
                                              i
4.5 . This draft follows on to the harmonization in the field of medical
      equipment already achieved in the form of Directive 84/ 539/EEC .
      It is planned to harmonize the sector completely within the time
      limits laid down in the White Paper .
Ύ
 ---pagebreak---                                        - 7 -
 5.    Progress in standardisation
       An ISO/ IEC joint working group has teen working for several years at
       world level on one of the categories of equipment falling within the
       scope of this draft , namely implantable cardiac stimulators .
      On this basis and on that of the essential safety requirements annexed
       to this draft , CENELEC adopted on March 1st 1988 European standard EN
       50061 relating to cardiac stimulators . A large part of its technical
      content applies to implants as a whole for which it may be easier and
      faster to prepare draft European standards .
6.    Closeness to the text of the "model directive "
       (Annexed to the Resolution of 7 May 1985 )
      As with other proposals for directives based on the new approach , the
      Commission has tried to keep as close as possible to the "model
      directive " given in the Annex to the Resolution of 7 May 1985 , while
      taking account of the information and opinions gathered d\n?ing the
      consultation of the interested parties .
      A.   The basic approach to the production of the dossier that shall be
           evaluated by the notified body(2) in order to ascertain the
           conformity of the device to the directive , can be reduced to the
           production of three sub documents :
( 2 ) For "notified body " we intend a body that has been notified to the
      Commission by each Member State as responsible for controls and use of
      the Directive .   This body shall not be necessarily of the same
      nationality of the Member State that notified it , and it can delegate
      to laboratories (either national or of another Member State ) the duty
      of making tests , controls , surveillance that however will stay under
      its own responsibility .
 ---pagebreak---                                    - 8 -
         1.  Quality system dossier for sterility
        2.   Clinical evidence dossier
        3 . Technical safety dossier(
    B.  In the first document the manufacturer shall disclose al 1 the
        informations related to the quality system that is implemented in
        his factory to ensure the sterility of the device . This system
        should be based on CEN 29001 and could be implemented by means of
         the use of a relevant guide to good-manufacturing practice (GMP ) .
        Where a registration and control system of manufacturers using
        such guide exists , document 1 could simply be a certificate to
        that extent .
    C.  In the second document , the manufacturer shall disclose all the
        informations related to the tests and the means used to verify ,
        from a clinical point of view , the performances and the principle
        of operation of the device . This document shall be countersigned
        by a specific consultant specialist of the pathology that the
       device is intended to treat or monitor .
       Literature on the principles of operation , if any , should be
        enclosed .
    D. Document 3 needs a more detail ed description .
       The first question arising is :
        " Is there any relevant harmonized standard for the device under
       consideration covering the essential safety requirements , or is
       there any relevant national standard published on the Official
       Journal of the European Communities ?"
(3 ) see enclosed block diagrams
 ---pagebreak---                                - 9 -
   1.  If the answer is " no " or if the manufacturer chooses not to
       apply them , then document 3 shall contain all the information
       related to the methods that the manufacturer has used to
       produce the device in conformity to the essential safety
       requirements , the tests done to verify it and a rationale
       explaining the consistency of such methods and tests with the
       essential safety requirements .
       For example in the above mentioned rationale reference could
       be made to specific requirements and tests contained in
       standards applicable to devices similar to the one considered .
       In this case the dossier shall be accompanied by a sample of
       the device .
   2.  If the answer is "yes " then two types of document can be
       generated :
       a) if the manufacturer applies a GMP he shall disclose his
           quality system together with the reference to the
           standards applied ,
       b) if the manufacturer does not apply a GMP , he shall
           disclose in detail how he has tested the device to claim
           its conformity to it (a certificate of conformity made by
           a third party is also suitable for this purpose ).
E. Once the dossier is then completed , it shall be presented to the
   notified body of one Member State . Depending on the way document
   3 hac been generated , the notified body will issue , after
   examination , one of the following certificates :
                                                                     ИО
 ---pagebreak---                            - 10 -
1 ) Pattern approval certificate , if the manufacturer has
    submitted document 3 according to point D.l .
2 ) Dossier approval certificate , if the manufacturer has
    submitted document 3 according to point D.2 .
At this moment , the manufacturer can sell freely his device
through EEC without the need of additional controls if it conforms
to either the pattern or the dossier approved .
To do so , the manufacturer shall declare that the device conforms
to the pattern or the dossier approved and shall label the device
with the EC mark .
In older to be allowed to make the above declaration the
manufacturer shall have either :
-   an approval of his quality system for design , purchase ,
    manufacture , final test and inspection based on CEN 29001 and
    the relevant GMP , or
    an approval of his quality system for purchase , manufacture ,
    final test and inspection based on CEN 29002 , or
    a certificate of inspection , made under the authority of the
    notified body ; stating that the production conforms to the
    pattern or the design approved .
 ---pagebreak--- Attestation of conforaity
The essential safety requirements to which implants must conform can
be classified under three headings , namely sterility , clinical
evaluation and technical safety . With regard to compliance with these
three aspects , the Directive establishes three different strands which
converge at the "design documents " stage and lead to the issue of a
Community mark of conformity .
Technical safety may be evaluated on the basis of tests carried out on
a prototype and evaluation will be facilitated if the design and
construction of the equipment is in accordance with standards . The
Directive therefore describes a set of procedures which are fairly
representative of the certification procedures normally set out in
Community directives .
Sterility will make it necessary to have rules and a strict
oganization of the manufacturing process .
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 ---pagebreak---                                          12
                                    Proposai for a
                                   COUNCIL DIRECTIVE
      on the approximation of the laws of the Member States relating to active
      implantable electromedical equipment
THE COUNCIL OF THE EUROPEAN COMMUNITIES ,
Having regard to the Treaty establishing the European Economic Community ,
and in particular Article 100a thereof ,
Having regard to the proposal from the Commission ,
In cooperation with the European Parliament ,
Having regard to the opinion of the Economic and Social Committee ,
Whereas , in each Member State , active implantable electromedical devices
used in human medicine must meet a high and clearly-defined level of safety
both for the users of such equipment and for those receiving treatment by means of
the equipment ;
Whereas several Member States have sought to ensure that level of safety
by mandatory specifications relating both to the technical safety
regulations and the inspection procedures , and whereas those specifications
differ from one Member State to another ;
Whereas the national provision ensuring such safety level should be
harmonized in order to guarantee the free market of active implantable
electromedical devices without lowering existing and justified levels of
safety in the Member States ;
                                                                           Λ
 ---pagebreak---                                  13
  Whereas the regulations for active implantable electromedical devices can
  be confined to those provisions needed to satisfy the essential safety
  requirements : whereas because they are essential these requirements must
  replace corresponding national provisions ;
  Whereas , inspection procedures have to be provided ,
  established on basis of mutual acceptance by the Member States in
  conformity with Community criteria ,
  HAS ADOPTED THIS DIRECTIVE :
                                     CHAPTER I
                                     Article 1
  1.   This Directive applies to active implantable electromedical devices .
yis
 ---pagebreak---                                       14
2. For the purpose of this Directive the following definitions shall
   apply :
   - Medical device : any instrument , apparatus , implement , substance or
      other article (used singly or in combination) which is intended by
      the manufacturer for use in humans for :
      a . Contraception ,
      b . Diagnosis , prevention , monitoring , treatment or alleviation of
          disease or injury ,
      c . Investigation or modification of the anatomy or of a
          physiological process ,
      which does not achieve its principal intended action by
      pharmacological means .
      Software packages which do not form part of an instrument ,
      apparatus , implement or article are excluded from this definition;
   - active implantable electromedical device : any medical device which
      is intended to be permanently implanted within the human body by a
      surgical operation , such a device using electricity from an
      implanted battery or an external source of power , together with
      non-interchangeable accessories (such as programmers , external
      power sources ) and operating software ;
   - permanently implanted : implantation within the human body for
      purposes other than for      short-term purposes .
 ---pagebreak---                                           15
                                     Article 2
Member States shall take all necessary steps to ensure that devices
referred to in Article 1 ( 1 ), hereinafter referred to as "devices ", nay be
placed on the’ market and implanted only if they do not impair patients'
safety , when properly implanted , maintained and used according to their
intended purposes .
                                     Article 3
The devices referred to in Article 1 (1 ) shall satisfy the essential safety
requirements set out in Annex 1 .
                                     Article 4
1.   Member States shall not impede the placing on the market , the free
     circulation and the implantation of devices bearing the CE-mnrk .
2.   Member States shall not , impede the placing' on the market aid the
     implantation of devices not bearing the CE-nark that are :
A
 ---pagebreak---                                      16
   - intended, for clinical evaluation according to the procedure of
      Article 8 (4 ) ;
   - of a prototype nature intended for research and safety and
      effectiveness testing .
3. From the date of notification of this Directive , devices may continue ,
   on a transitional basis for a period of 3 years/’ to be placed on the
   market subject to national provisions already in force on that date ,
   provided that any such provisions axe compatible with the requirements
   of the Treaty .
                                Article 5
1. Member States shall presume compliance with the essential safety
   requirements referred to in Annex 1 in respect of devices wliich axe in
   conformity with :
   a) the relevant national standards implementing the harmonized
      standards the references of which have been published in the
      Official Journal of the European Communities ; Member States shall
 ---pagebreak---         publish the references of such national standards ;
or with
     b) the relevant national standards referred to in paragraph 2 insofar
        as , in the areas covered by such standards , no relevant harmonized
        standard exists .
2.   Member States shall communicate to the Commission the texts of their
     national standards , as referred to in paragraph lCb ), which they
     regard as complying with the essential safety requirements referred to
     in Annex 1 .     The Commission shall forward such texts forthwith to the
     Member States . In accordance with the procedure provided for in
     Article 6 ( 2 ), it shall notify the Member States of those national
     standards in respect of which there is a presumption of conformity
     with the essential safety requirements referred to in Annex 1 .
     Member States shall publish the reference numbers of those standards .
     The Commission shall also publish them in the Official Journal of the
     European Community .
                                     Article 6
1.   Where a Member State or the Commission considers that the harmonized
     standards referred to in Article 5(1) do not entirely meet the
     essential safety requirements referred to in Article 3 , the Commission
     or the Member State concerned shall bring the matter before the
     Standing Committee set up under Directive 83/ 189/ EEC , hereinafter
     referred to as " the Committee ", giving the reasons therefor . The
     Committee shall deliver an opinion without delay .
 ---pagebreak---                                      13
   In the light of the Committee 's opinion , the Commission shall inform
   the Member States whether or not it is necessary to withdraw those
   standards from the publications referred to in Article SCDfeO .
2. On receipt of the communication referred to in Article 5 (2),
   the Commission shall consult the Committee .   After the Committee has
   given its opinion the Commission shall , within a given period , notify
   the Member States whether the national standard in question should or
   should not enjoy presumption of conformity and , if so , be subject to
   national publication of its references .
   If the Commission or a Member State considers that a national standard
   no longer fulfils the conditions for presumption of conformity to the
   safety requirements , the Commission shall consult the Committee . In
   the light of the opinion of the Committee , it shall notify the Member
   States whether or not the standard in question should continue to
   enjoy presumption of conformity and in the latter case be withdrawn
   from the publications referred to in Article 5 (2-) .
                                Article 7
1. Where a Member State firds that devices bearing the CE-mark do not
   satisfy the essential safety requirements when properly implanted and
   used in accordance with their intended purpose , it shall take all
   appropriate measures to withdraw those products from the market or to
   prohibit or restrict their being placed on the market .
 ---pagebreak---                                     19
The Member State concerned shall immediately inform the Commission of
any such measure , indicating the reasons for its decision , and in
particular whether non compliance is due to :
a) failure to meet the essential safety requirements referred to in
   Article 3 , where the device does not meet the standards referred to
   in Article 5 (1) ;
b) incorrect application of the standards referred to in Article 5<1>;
c) shortcomings in the standards referred to in Article 5 (1>
   themselves .
The Commission shall enter into consultation with the parties
concerned as soon as possible . Where , after such consultation , the
Commission finds that any measure as referred to in paragraph 1 is
justified , it shall immediately so inform the Member State that took
the action and the other Member States .  Where the decision referred
to in paragraph 1 is attributed to shortcomings in the standards the
Commission , after consulting the parties concerned , shall bring the
matter before the Committee within two months if the Member State
which has taken the measures intends to maintain them and shall
initiate the procedures referred to in Article 6 .
Where a device which does not comply bears the CE-mark the competent
Member State shall take appropriate action against whomsoever has
affixed the mark and shall inform the Commission and the other Member
States thereof .
 ---pagebreak---                                         20
4. The Commission shall ensure that the Member States are kept informed
    of the progress and outcome of this procedure .
                                  CHAPTER II
                            Conformity assessment
                                  Artide 8
1. Devices shall be subject to the EC type examination as described in
   Annex 2 section 2 .
2. After having complied with       paragraph   1,  the
   manufacturer , or his authorized representative established within the
   Community , to be allowed to affix the CE-mark on his devices shall , at
   his own choice , either :
   a) apply for EC declaration of production conformity as described in
       Annex 2, section 4
   b) apply for EC declaration of production conformity as described in
       Annex 2, section 3 .
 ---pagebreak--- Devices that axe made according to standards referred to in Article
5 CL)can be subject , as an alternative to the provisions of paragraphs 1
axd. 2 and at manufacturer 's choice, to the EC declaration of design
conformity as described in Annex 2, section 1 .
Such a declaration being integrated by the EC declaration of
production conformity as described in Annex 2, section 4 .
Standards referred to in Article 5 Cl) are of two different types :
technical and clinical ; for the latter , waiting for the production of
an harmonized standard , devices shall be evaluated clinically
according to the provisions of Annex 5 .
The records and correspondence relating to the procedures referred to
in paragraphs 1 , 2 and 3 shall be in an official language of the
Member State where the said procedures will' be carried out , or in a
language acceptable to the notified body .
                                Article 9
Member States shall notify to the other Member States and the
Commission the bodies which they have designated for carrying out
tasks pertaining to the procedures referred to in Article 8 , the
specific tasks for which each, body has been designated , and the
identification codes of the designated bodies .
 ---pagebreak---                                    - 22
   The Commission shall publish the list of these notified bodies ,
   together with the tasks for which they have been designated , in the
   Official Journal of the European Communities and shall ensure that the
   list  is kept up to date .
2. Member States shall apply the minimum criteria , set out In Annex 4 ,
   for the designation of bodies . Bodies that satisfy the criteria fixed
   by the relevant harmonized standards shall be presumed to satisfy the
   criteria set out in Annex 4 .
3. A Member State that has designated a body shall annul the designation
   if the body no longer meets the criteria for designation referred to
   in paragraph 2 . It shall immediately inform the other Member States
   and the Commission accordingly and withdraw the notification .
 ---pagebreak---                                     23
                                CHAPTER III
                  CE-rrark of confonnity ard inscriptions
                                 Artide 10
 1. The CE-mark of conformity as referred to in Annex 3 shall be affixed
    to the device where practicable or on the package or on the
    accompanying documents in a clearly visible , easily legible and
    indelible form .
 2. The affixing of marks which are likely to be confused with the CE-mark
    of conformity shall be prohibited .
25
 ---pagebreak---                                     - 24
                                 Article 11
Where it is established that the CE-mark      been wrongly affixed to
devices because :
     - they do not conform to the relevant standards referred to in
        Article 5 (1) ;
     - they do not conform to an approved type
     - they conform to an approved type which does not meet the essential
        requirements applicable to it
     - the manufacturer has failed to fulfil his obligations under the
        relevant EC declaration of production conformity
the inspection body shall withdraw the EC design approval certificate or
the EC quality systems approval certificate .
                                                                         36
 ---pagebreak---                                              25
                                         CHAPTER IV
                                         Article 12
Any decision taken pursuant to this Directive and resulting in restrictions
on the placing on the market and/ or taking into service of a device shall
state the exact grounds on which it is based . Such decision shall be
notified without delay to tlie party concerned , wlio 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 .
                                         Article 13
1.   Before 1 July 1991 , I'nemoer States shall adopt and publish the laws ,
     regulations and administrative provisions necessary in order to comply
     with this Directive .        They shall forthwith inform the Commission
     thereof .
     They shall apply such provisions from 1 January 1992 .
2.   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 .
П
 ---pagebreak---                                    - 26 -
                                Article 14
This Directive is addressed to the Member States .
Done at Brussels                              For the Council
                                              The President
 ---pagebreak---                                        7.1
                                    АШЕХ   1
Essential safety requirements for active implantable electromedical
devices .
 1.  Sterillty
     Patients shall be adequately protected against the risks caused by the
     vise of non-sterile products .
2.   dlnical évaluation
     2.1 .   The clinical conditions of the patient shall not be worsened by
             the implantation of the device .
     2.2 .   Side effects or any undesirable conditions introduced by the
             device shall not outweigh! its positive effect .
3.   Technical evaluation
     3.1 .   Protection against misuse
             The function of such devices shall be laid down in the
             instructions for use and on the labelling in order to ensure .
     3.1.1 .    That physicians are fully aware of the potential and
                limitations of such devices .
     3.1.2 .    That physicians have sufficient information to make a correct
                decision about utilization of the device .
     3.1.3 .    That product parameters and packaging information shall be
                given in such a way that misinterpretations are minimized .
&
 ---pagebreak---                                 - 28
3.2 .   Protections against hazards arising from the device
        Measures of a technical nature shall be taken in order to
        ensure :
3.2.1 .    That patients are adequately protected against risk of
           physical injury which might be caused by product design such
           as physical and dimensional features together with the
           biological characteristics of the materials used .
3.2.2 .    That patients are adequately protected against power supply
           depletion by means of a manufacturer 's statement with respect
           to the end of life criteria .
3.2.3 .    That patients are adequately protected against the hazards
           related to the use of electricity such as :
           a) poor insulation
           b) excessive leakage currents for the intended use
           c) poor protection of electrical circuits from the risk of
              contacts with body fluids
           d) excess heat generated by the device .
3.2.4 .    Protection against hazards caused by the impossibility of
           carrying on systematic maintenance and calibration such as :
           a) significant détérioration in performance features ,
           b) excessive increase of leakage currents ,
 ---pagebreak---                                    29
         c) degradation of the materials 'used ,
         d ) ingress of body fluids or leakage of containers ,
         e ) excessive increase of device-generated heat .
 3.2.5 . Protection against hazards which might be caused by
         environmental influences .
         a) The device shall be designed and manufactured in such a
             way that mechanical stress which may occur during normal
             use will not irreversibly degrade its safety .
         b) The device shall be manufactured and packed in such a way
             that it can resist , within the limits set by the
             manufacturer , to the environment conditions variations
             ( temperature , humidity) that could occur either in normal
             use and during transport and storage , in such a way that
             its performance will not be irreversibly degraded , to such
             a degree that patient 's safety is jeopardized .
         c ) Measures shall be adopted in order to reasonably protect
             the patient in which the device has been implanted , from
             the hazards arising from electromagnetic fields or from
             external electrical influences (defibrillators , high
             frequence surgical equipment , etc . ) .
2λ
 ---pagebreak---                                       - 30 -
                                    ANNEX   2
                       Conformity assessment procedure
1.    EC Declaration of design conformity
1.1 The EC declaration of design conformity is the process whereby the
      manufacturer who satisfies the obligations of paragraph 1.2 declares
      that the design of the type concerned satisfies the requirements of
      the directive that apply to it .
1.2 . Obligations
1.2.1    The manufacturer shall have adequately implemented a quality system
         for design control that will ensure that design output will meet
         approved design requirements , and is subject to EC surveillance as
         specified in paragraph 1.5 .
1.2.2    The manufacturer shall mike only once the application for the whole
         quality system covering the provisions of this section and those of
         section 4 of this annex , with the exceptions of the provisions of
         paragraphs 1.4 , and when new technologies are introduced in the
         production process , together with a new product .
1.3 Quality system
1.3.1    The manufacturer shall lodge an application for approval of his
         quality system with a notified body .
                                                                            3Z
 ---pagebreak---                                          31
The application shall inclue
        -  the quality system 's documentation and a.l 1 other relevant
           information
        - an undertaking    to carry out the obligations arising from the
           quality system   as approved
        - an undertaking    to maintain the approved quality system to ensure
           its continuing   suitability and effectiveness .
1.3.2   All the elements , requirements and provisions adopted by the
        manufacturer shall be documented in a systematic and orderly manner
        in the form of written policies , procedures and instructions . This
        quality system documentation shall ensure a common understanding of
        the quality policies and procedures such as quality programmes ,
        plans , manuals , and records .
        It shall contain in particular an adéquate description of
        - the quality objectives , and the organizational structure and
           responsibilities of management and their powers with regard to
           design quality
        - the design control techniques , processes , and systematic actions
           that will be used
        - the design verification techniques , processes , and systematic
           actions that will be used , and the frequency with which they
           will be used .
        -  the means to monitor the achievement of the required design
           quality anrl tho orf'ool.lvn rq>nral,lnii of l.ho qna'M.ty / rynt.cyii .
&
 ---pagebreak---                                        32
1.3.3    The notified body shall examine and evaluate the quality system to
         determine whether it satisfies the requirements referred to in
         paragraph 1.3.2 . It shall presume compliance with these
         requirements in respect of quality systems that Implement the
         design 'elements of the corresponding harmonized standard .
         The notified body shall notify its decision to the manufacturer and
         inform the other notified bodies thereof . The notification to the
         manufacturer shall contain the conclusions of the examination and
         the reasoned assessment decision .
1.3.4    The manufacturer or his authorized representative established in
         the Community shall keep the notified body that has approved the
         quality system informed of any updating of the quality system in
         relation to changes brought about by , e . g . , new design technologies
         and quality concepts .
1.3.5    A notified body that withdraws approval of a quality system shall
         so inform the other notified bodies , giving the reasons for the
         decision .
1.4 Design requirements
     The manufacturer shall establish the design requirements of the type
      on the basis of the requirements of the directive that apply to it ,
     and submit those to the notified body .
     The notified body shall examine and evaluate the design requirements
      to determine whether they satisfy the relevant requirements of this
     directive . It shall notify its decision to the manufacturer and inform
      the other notified bodies thereof . The notification to the
     manufacturer shall contain the conclusions of the examination and the
     reasoned assessment decision .
     The notified body shall also verify whether the clinical tests have
     been carried out according to the provisions of Article 8 paragraph 4 .
                                                                                àk
 ---pagebreak---                                       33
1.5   EC
1.5.1    The purpose of EC surveillance is to make sure that the
         manufacturer duly fulfils the obligations arising out of the
         approved quality system .
1.5.2    The manufacturer shall , upon request , provide all necessary
         Information to the notified body , in particular
         - the quality system documentation
         - the approved design requirements
         - the up to date quality records as foreseen by the quality
            system , such as results of analyses , calculations , tests , etc .
1.5.3    The notified body shall make sure that the manufacturer maintains
         and applies the quality system .
         It shall provide a surveillance report to the manufacturer .
2.    BC type erarnl nati nn
2.1 The EC type examination is that part of the procedure by which a
     notified body ascertains and certifies that a product , representative
      of the production envisaged , meets the provisions of the directive
      that apply to it .
2.2 The application for the type examination shall be lodged by the
     manufacturer or his authorized representative established within the
     Community with a single notified body .
 ---pagebreak---                                        34
The application shall include
     - the name and address of the manufacturer and , if the application is
         lodged by the authorized representative , his name and address in
         addition
     - a written declaration that the application has not been lodged with
         any other notified body
     - the design documentation , as described in paragraph 2.3
     The applicant shall place at the disposal of the notified body a
     product , representative of the production envisaged hereinafter called
     " type " . The notified body may request further samples of the type if
     needed by the test programme .
     A type may additionally cover product variants provided that any
     modification does not affect the level of safety and other performance
     requirements of the type .
2.3 The design documentation shall contain so far as relevant for
     assessment :
     - a general description of the type
     - conceptual designs and manufacturing drawings and schemes of
         components , sub-assemblies , circuits , etc .
     - descriptions and explanations necessary for the understanding of
         the above including the operation of the products .
     - a list of the standards referred to in article 5 , applied in full
         or in part and descriptions of the solutions adopted to meet the
         essential requirements where the standards referred to in article 5
         have not been applied
     - results of design calculations made and of examinations etc .
     -   test reports
     - a report on clinical tests according to the provisions of Article 8
         paragraph 4 .
 ---pagebreak---                                         35
  2.4 The notifie! body shall ,
  2.4.1    examine the design document and verify that the type has been
           manufactured in conformity with the design documentation and
           identify the elements which have been designed in accordance with
           the relevant provisions of the standard and the essential
           requirements of the directive ;
 2.4.2    perform or have performed the appropriate examination and/ or tests
          to check whether the solutions adopted by the manufacturer meet the
          essential requirements where Uio uL'udux.ki refer mi to in arLio.l u 15
          have not been applied ;
 2.4.3    perform or have performed the appropriate examinations and/ or tests
          to check whether the relevant standards were effectively applied
          where the manufacturer has chosen to do so thereby assuring
          conformity with the essential requirements ;
 2.4.4    agree with the applicant the location where the examination and/ or
          tests shall be carried out .
 2.5 Where the type meets the provisions of the directive the notified body
       shall issue an BC type approval certificate to the applicant . The
       certificate shall contain the conclusions of the examination ,
       conditions (if any) for its validity , and the necessany data for
       identification of the approved type and if relevant description of its
       functioning . The relevant technical elements such as drawings and
       schemes shall be annexed to the certificate .
 2.6 The other notified bodies shall be informed forthwith of the issuing
       of the EC type approval certificate and its additions referred to in
       2.8.2 on the said type . They may obtain a copy of the EC type approval
       certificate and its additions and on a reasoned request may obtain a
       copy of the annexes to the certificate aid. the reports on the
       examinations and tests carried out .
3V
 ---pagebreak--- 2.7 A notified body that refuses to issue or withdraws an EC type approval
      certificate shall so inform the Member State which notified this body
      and the other notified bodies giving the reasons for the decision .
2.8.1    The applicant shall keep the notified body that has issued the EC
         type approved, certificate informed of any modification to the
         approved type .
2.8.2    Modifications to the approved type must receive additional approval
         from the notified body that issued the EC type approval certificate
         where such changes affect the safety of patients when properly
         implanted , maintained and used according to their intended purpose .
         This additional approval is given in the form of an addition to the
         original EC type approval certificate .
3.   BC declaration of production conformity ( type 1 )
3.1 The EC declaration of production conformity ( type 1 ) is that part of
     the procedure whereby the manufacturer declares that the products
     concerned are in conformity with the type as described in the EC type
     approval certificate and satisfy the requirements of this directive
     that apply to them . The manufacturer shall affix the CE-mark to each
     product and draw up a written declaration of conformity . The CE-mark
     shall be accompanied by the identification symbol of the notified body
     responsible for the random checks set out in paragraph 3.3 .
3.2 The manufacturer shall take all measures necessary in order that the
     manufacturing process including final product inspection and testing
     shall ensure homogeneity of production and compliance of the products
     with the type as described in the EC type approval certificate and
     with the requirements of the directive that apply to them . A notified
     body , chosen by the manufacturer , shall carry out random checks on
     products as set out in either paragraph 3a or 3b below .
 ---pagebreak---                                        37
 3.3 a ) The products shall be subject to statistical control where
         applicable and shall therefore be grouped into identifiable lots
         consisting of units of a single model and manufactured under
         essentially the same conditions . A sample is to be drawn and
         inspected to determine conformity with the acceptability criteria .
         The operating characteristics are specified below . In those cases
         where a batch is rejected the notified body shall take the
         appropriate measures to prevent the putting on the market of that
         batch .
 3.3 b) On site product checks shall be undertaken at random intervals of
         one year or less . A sample of the product shall be examined and
         appropriate tests as set out in the relevant standard(s ) referred
         to in Article 5 or equivalent tests shall be carried out in order
         to ensure their conformity with the relevant requirements of the
         directive . In those cases where one of the products under
         examination does not conform , the notified body shall take measures
         appropriate to the nature of the defect(s ).
 4.  EC declaration of production conformity (type 2j
 4.1 The EC declaration of production conformity (type 2 ) is the procedure
     whereby the manufacturer who satisfies tic obligations of paragraph 2
     declares that the products concerned are in conformity with the type
     as described in the EC type approval certificate and satisfy the
     requirements of this directive that apply to them . The manufacturer
     shall affix the CE-mark to each product and draw up a written
     declaration of conformity . The CE-mark shall be accompanied by the
     Identification symbol of the notified body responsible for EC
     surveillance .
35
 ---pagebreak---                                       _  7 0   .
                                          >i *
4.2.1    The manufacturer shall have adequately Implemented a quality system
         that will ensure compliance of the products with the type as
         described in the EC type approval certificate or in the EC
         declaration of design, conformity and with the requirement ( s ) of
         this directive that apply to them . The manufacturer is subject to
         EC surveillance as specified in section 4 paragraph 4 .
4.2.2    The manufacturer shall make only once the application for the
         quality system mentioned in this section , with the exception of the
         case when new technologies are introduced in the production process
         in view of a new product .
4 . 3 Quality system
4.3.1 .  The manufacturer shall lodge an application for approval of his
         quality system with a notified body
         The application shall include :
         - a.l 1 relevant information , in particular the quality system 's
            documentation and the design documentation of the approved type
         - an undertaking to carry out the obligations arising from the
            quality system as approved
         - an undertaking to maintain the approved quality system to ensure
            its continuing suitability and effectiveness .
                                                                             H0
 ---pagebreak---                                          39
 4.3.2 .  All the elements , requirements and provisions adopted by the
          manufacturer shall be documented in a systematic and orderly manner
          in the form of written policies , procedures and instructions . This
          quality system documentation shall ensure a common understanding of
          the quality programmes , plans , manuals , and records .
      It shall contain in particular an adéquate description of
      -   the quality objectives , and the organizational structure and •
         responsibilities of management and of their powers with regard to
         product quality
      -  the manufacturing processes , quality control and quality assurance ,
         techniques and systematic actions that will be used
      - the examinations and tests that will be carried out before , during
         and after manufacture , and the frequency with which they will be
         carried out
      -  the means to monitor the achievement of the required product
         quality and the effective operation of the quality system .
4.3.3 .  The notified body shall examine and evaluate the quality system to
         determine whether it satisfies the requirements referred to in
         section 3 , paragraph 2 . It shall presume comformity with these
         requirements in respect of quality systems that implement the
         corresponding harmonized standard .
         It shall notify its decision to the manufacturer and inform the
         other notified bodies thereof . The notification to the manufacturer
         shall contain the conclusions of the examination and the reasoned
         assessment decision .
4.3.4    The manufacturer or his authorized representative shall keep the
         notified body that has approved the quality system informed of any
         updating of the quality system in relation to changes brought about
         by , e.g. , new technologies and quality concepts .
kA
 ---pagebreak---                                       40
4.3.5    A notified body that withdraws approval of a quality system shall
         so inform the other notified bodies , giving the reasons for the
         decision .
4.4   EC surveillance
4.4.1    The purpose of EC surveillance is to make sure that the
         manufacturer duly fulfils the obligations arising out of the
         approved quality system .
4.4.2    The manufacturer shall allow the notified body entrance for
         inspection purposes to the locations of manufacture , inspection and
         testing , and storage and shall provide it with all necessary
         information , in particular
         - the quality system documentation
         - the design documentation
         - the quality records , such as inspection reports and test data ,
            calibration data , qualification reports of the personnel
            concerned , etc .
4.4.3    The notified body shall make sure that the manufacturer maintains
         and applies the quality system and shall provide a surveillance
         report to the manufacturer .
                                                                            HI
 ---pagebreak---                                     41
                                  ANNEX  3
                                            fWgS^i
                                            mm
                                                   mmm
Devices shall be Identified by the manufacturer by means of type-, batch-
or serial numbers .
«
 ---pagebreak---                                        42
                                   ANNEX  4
MINIMUM CRITERIA TO BE TAKEN INTO ACCOUNT BY MEMEER STATES WHEN APPOINTING
INSPECTION BODIES
                                                                  «
1.   The notified body , its director and the staff responsible for carrying
     out the verification tests shall not be the designer , manufacturer ,
     supplier or installer of apparatus which they inspect , nor the
     authorized representative af any of those parties . They shall not
     become directly involved in the design , construction , marketing or
     maintenance of the apparatus , nor represent the parties engaged in
     these activities .  This does not preclude the possibility of exchanges
     of technical information between the manufacturer and the notified
     body .
2.   The notified body and its staff must carry out the verification tests
     with the highest degree of professional integrity and technical
     competence and must be free from all pressures and inducements ,
     particularly financial , which might influence their judgment or the
     results of the inspection , especially from persons or groups of
     persons with an interest in the result of verifications .
3.   The notified body must have at its disposal the necessary staff and
     possess the necessary facilities to enable it to perform properly the
     administrative and technical tasks connected with verification ; it
     must also have access to the equipment required for special
     verification .
 ---pagebreak---                                     A3
 4. The staff responsible for inspection must have :
    - sound technical and professional training ,
    - satisfactory knowledge of the requirements of the tests they carry
       out and adequate experience of such tests ,
    - the ability to draw up the certificates , records and reports
       required to authenticate the performance of the tests .
 5. The impartiality of inspection staff must he guaranteed . Their
    remuneration must not depend on the number of tests carried out nor on
    the results of such tests .
 6. The notified body must take out liability insurance unless its
    liability is assumed by the State in accordance with national law , or
    the Member State itself is directly responsible for the tests .
 7. The staff of the notified body is bound to observe professional
    secrecy with regard to all information gained in carrying out its
    tasks (except vis-a-vis the competent administrative authorities of
    the State in which its activities are carried out ) under this
    Directive or any provision of national law giving effect to it .
HS
 ---pagebreak---                                     - 44 -
                                    ANNEX5
Clinical évaluation
m i ni nal evaluation can be checked by means of clinical tests performed
according to the following points :
1.     Clinical tests shall be performed in a recognized clinical environment
       specific for the pathologies that the device is intended to treat .
2.     Clinical tests shall be performed under the responsablllty of a
       recognized consultant specialist in the relevant pathology .
3.     The procedures utilized to perform clinical tests shall be consistent
       with the device under examination .
4.     Methods to perform the tests shall be consistent with the device under
       examination .
5.     All appropriate features involving safety of the device shall be
       examined .
                                                                           14
 ---pagebreak---                                        1
                             FINANCIAL STATEMENT
regarding the proposal for a Council Directive on the approximation of the
laws of the Member States relating to active implantable electromedical
equipment (hereinafter referred to as implants ) .
1.  Introduction
    The proposal for a Directive on implants defines the essential safety
    requirements which they must satisfy . Article 5 of the proposal
    specifies that there should be a general reference , as a matter of
    priority , to European standards or , as a transitional measure , to
    national standards in so far as European standards do not exist .
    Equipment manufactured in accordance with these standards is deemed to
    conform to the essential requirements concerned in the Directive .
    The Commission plans to help strengthen European standards by assigning
    to CEN and/or CENELEC the task of preparing the harmonized standards
    required in the implants sector in accordance with the general
    guidelines on cooperation between the Commission , CEN and CENELEC
    approved on 13 November 1984 . This work will be carried out within the
    framework of mandates assigned to CEN and/ or CENELEC pursuant to the
    framework contracts signed on 10 October 1985 , which provide for
    financial support from the Commission .
    The above mentioned work , which is of a limited duration , must be
    integrated within the general management framework of the Directive ,
    which is a long-term project .
hr
 ---pagebreak---                                         - 2 -
       Th^ figures given nan only be summary estimates since European
       staxdardization is still at the planning stage .
  2 . Budget headings concerned
       Article 775 :              Projects concerning the internal market
       Item 7750                  Harmonization of industrial and occupational
                                  legislation
                                  Multiannual project to strengthen the European
                                  standards bodies .
 3.    Legal basis
 3.1 .    Council Resolution of 7 May 1985 on a new approach to technical
          harmonization and standards^).
 3.2 . Directive to be adopted by the Council providing for the alignment of
          the laws of the Member States relating to active implantable
        _ electromedical equipment .
 4:    Proposed classification
       Non-corttpulsory expenditure .
Cl ) OJ C 136 , 4.6.1985 .
 ---pagebreak---                                         - 3 -
  5.    Description and justification of the project .
  5.1 .   Objectives
          The projects planned should help in drawing up harmonized standards
          which meet the essential requirements of the Directive on implants
          and without which it would be very difficult to apply the Directive .
          The harmonized standards will also help to strengthen the
          competitiveness of European industry .
 5.2 .    Persons concerned
          In agreement with the Council Resolution of 7 May 1985 ,
          standardization is not the responsibility of the Commission , but that
          of the European standards bodies .
 6.     Type of expenditure and method of calculation
 6.1 .    Type
          It concerns mandates for the execution of the framework contract of
          10 October 1985 between the Commission and CEN/CENELEC .
 6.2 .    Calculation
          The amount of finance for the services will be determined for each
          order in the light of the work assigned to the contractors .
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      It jnninfiflg the expenditure incurred by the central departments of
      the European standards bodies in implementing the standards
      programmes assigned to them and a contribution to the expenditure
      incurred by the technical committees and working parties in carrying
      out the programmes . To this expenditure may be added specific
      expenditure in respect of experts assigned specific work in this
      context .
      The expenditure is calculated on the basis of the "man/month" •unit ,
      which currently stands at 5.000 ECU .
      The work of drawing up the harmonized standards will certainly have
      to continue beyond the first five years .
7 . Financial Implications for operating appropriations
7.1 . Timetable of commitment and payment appropriations :
      (Item 7750)
                               CA (ECU)                 PA (ECU)
           1988                100.000                   50.000
           1989                100.000                  150.000
           1990                200.000                  150.000
           1991                100.000                  100.000
           1992                  p.m .                   50.000
                               500.000                  500.000
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  7.2 .    Proportion financed from the Corarnunity budget
           Since the parties involved in the standards work will in principle
          bear their own costs , the Community contribution to the funding of
          the project should not exceed 50 % of the total expenditure .
          However , it should be noted that the Community contribution will be
          lower if the EFTA countries decide to take part .
 8.     Observations
        None
 9.     Financial implications for staff and current administrative
       appropriations
 9.1 .    Staff working exclusively on the project .
          The project also includes management of the Directive on active
          implantable electromedical equipment , which will require the full¬
          time participation of the Commission departments concerned .
          From 1988 one A official will be needed for six months a year and one
          B official full-time .
 9.2 . + 9.3 .     Staff and current administrative appropriations
                  The appropriations required are estimated at 120.000 ECU a
                  year .
6Л
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             OCMPETITIVENESS AND HiPLOïMEOT IMPACT STATEMENT
I. What is the main reason for introducing the measure ?
   Active , implantable electromedical equipment , hereinafter referred to
   as Implants , constitutes a high-technology sector which is rapidly
   developing and making a major contribution to the health and survival
   of a large number of people .
   Within the Community , there are substantial differences between the
   national regulations In this field as regards clinical evaluation ,
   technical requirements , the means of attestation of conformity and
   surveillance of manufacturing processes . The incompatibility of these
   laws and the need to repeat certain procedures slow down technical
   innovation and delay the marketing of equipment which represents a
   technological breakthrough and 1s able to save the lives of further
   categories of patients .
   This disparity also hampers Intra-Community trade as it introduces
   technical barriers to the free movement of goods within the Community
   and thus constitutes a barrier to the completion of the internal
   market .
   The aim of this proposal for a Directive is to ensure the free placing
   on the market and commissioning of Implants that meet the basic safety
   requirements of the Directive , which have to be duly attested .
                                                                         Si
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  II .  Features of the businesses in question . In particular :
       Are there many SMEs ?
       Yes , although the exact member is difficult to determine due to the
       lock of precise information from the federations concerned .
 III . What direct obligations does this measure impose on businesses ?'
       From the date of entry into force of this Directive , all the
       appliances covered will have to be designed , manufactured and equipped
       in such a way as to satisfy the requirements of the Directive .
 IV . What indirect obligations are local authorities likely to impose an
       businesses ?
       The Directive will be applied in each Member State following its
       transposition into national law .
 V.    Are there any special measures in respect of SMEs ?
       NO .
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VI . What is the likely effect on ?
     - the competitiveness of businesses ?
     The placing on  the market of implants which carry the EG nark of
     conformity and  which are declared to conform to the Directive will be
     simplified and  expedited , which will reduce the marketing costs of
     manufacturers , importers and retailers . It will no longer be possible
     to create any obstacles to the free movement of such implants within
     the internal market , which will increase the technological
     competitiveness of the businesses in this sector .
     - employment ?
     A reduction in marketing costs should generally increase the
     competitiveness of the Community businesses in this sector , which will
     probably have a favourable effect on the employment market .
VH . Have both sides of .industry been consulted ?
     The IAPM , which includes the manufacturers of active implantable
     electromedical equipment , and the medical users of such equipment have
     played an active part in the work of the group of experts which helped
     in drafting this proposal for a Directive .