CELEX: 51992PC0356
Language: en
Date: 1992-07-28
Title: Amended proposal for a COUNCIL DIRECTIVE relating to the medical devices

No C 251 / 40                               Official Journal of the European Communities                                          28 . 9 . 92
                             Amended proposal for a Council Directive relating to the medical devices
                                                              ( 92 / C 251 / 02
                                                    (COM (92) 356 final — SYN 3 S3)
                (Submitted by the Commission, pursuant to Article 149 (3) of the EEC Treaty on 28 July 1992)
               On the left side you will find the initial text of the 'Whereas' articles and annexes of the proposal for a
               Council Directive on medical devices COM(91 ) 287 final SYN 353 ( J ).
               On the right side you will find the modifications proposed by the Commission .
               (M OJ No C 237 , 12 . 9 . 1991 , p. 3 .
                           INITIAL TEXT                                                              MODIFIED TEXT
                         Fourth Recital                                                              Fourth Recital
Whereas the harmonized provisions must be distinguished                    Whereas the harmonized provisions must be distinguished
from the measures adopted by the Member States to manage                   from the measures adopted by the Member States to manage
the funding of public schemes relating directly or indirectly to           the funding of public health and sickness insurance schemes
such devices ; whereas , therefore these provisions do not                 relating directly or indirectly to such devices ; whereas ,
affect the ability of the Member States to implement the                   therefore , these provisions do not affect the ability of the
abovementioned measures provided Community law is                          Member States to implement the abovementioned measures
complied with ;                                                            provided Community law is complied with ; whereas this
                                                                           means , inter alia , that Member States may determine which
                                                                           categories and types of device are eligible for reimbursement
                                                                           under such public health and sickness insurance schemes , but
                                                                           once those categories and types of device are determined , all
                                                                           devices within those categories or of those types which
                                                                           comply with the provisions of this present Directive should in
                                                                           principle be reimbursable under such public health and
                                                                           insurance schemes ;
                          Sixth Recital                                                               Sixth Recital
Whereas certain medical devices are intended to administer                 Whereas certain medical devices are intended to administer
medicinal products within the meaning of Council Directive                 medicinal products within the meaning of Council Directive
65 / 65 / EEC of 26 January 1965 on the approximation of                   65 / 65 / EEC of 26 January 1965 on the approximation of
provisions laid down by law , regulation or administrative                 provisions laid down by law , regulation or administrative
action relating to proprietary medicinal products ( J ), as last           action relating to proprietary medicinal products (*), as last
amended by Directive 89 / 381 / EEC ( 2 ); whereas , in such               amended by Directive 92 / 27 / EEC ( 2 ); whereas , in such
cases , the placing of the medicinal product on the market is              cases , the placing of the medicinal product on the market is
governed by Directive 65 / 65 / EEC ; whereas a distinction                governed by Directive 65 / 65 / EEC and the placing of the
must be drawn between the above mentioned devices and                      device on the market by this present Directive ; whereas a
medical devices incorporating , inter alia , substances which ,            distinction must be drawn between the abovementioned
if used separately , may be considered to be a medicinal                   devices and medical devices incorporating substances which ,
substance within the meaning of Directive 65 / 65 / EEC ;                  while not designed to be administered as a medicinal
whereas in such cases , if the substances are incorporated in              product , are bioavailable within the meaning of this
the medical devices to help them operate , the placing of the              Directive and if used separately , may be considered to be a
devices on the market is governed by this Directive ; whereas              medicinal substance within the meaning of Directive
in this context , in the event of the bioavailability of such              65 / 65 / EEC ; whereas , in such cases , if such substances are
substances , the safety , quality and usefulness of the                    incorporated in a medical device to improve its safety , quality
substances must be verified by analogy with the appropriate                or performance , the placing of such devices on the
methods specified in Council Directive 75 / 31 8 / EEC of                  market is governed by this present Directive ; whereas , in this
 ---pagebreak--- 28 . 9 . 92                                   Official Journal of the European Communities                                 No C 251 / 41
                              INITIAL TEXT                                                            MODIFIED TEXT
20 May 1975 on the approximation of the laws of the                      context, in the event of the bioavailability of such substances ,
Member States relating to analytical , pharmaco­                         the safety , quality and usefulness of the substances must be
toxicological and clinical standards and protocols in respect            verified by means of control systems which may be analogous
of the testing of proprietary medicinal products ( 3 ), as last          to the appropriate methods specified in Council Directive
amended by Directive 89 / 341 / EEC ( 4 );                               75 / 31 8 / EEC of 20 May 1975 on the approximation of the
                                                                         laws of the Member States relating to analytical ,
(')   OJ  No  22 , 9 . 2 . 1965 , p. 369 .                               pharmaco-toxicological and clinical standards and protocols
( 2)  OJ  No  L 181 , 28 . 6 . 1989 , p. 44 .                            in respect of the testing of proprietary medicinal products ( 3 ),
(3)   OJ  No  L 147 , 9 . 6 . 1975 , p. 1 .                              as last amended by Directive 91 / 507 / EEC ( 4 );
(4)   OJ  No  L 142 , 25 . 5 . 1989 , p. 11 .
                                                                         H     OJ No   22 , 9 . 2 . 1965 , p. 369 .
                                                                         (2)   OJ No   L 113 , 30 . 4 . 1992 , p. 8 .
                                                                         ( 3)  OJ No   L 147 , 9 . 6 . 1975 , p. 1 .
                                                                         (4 )  OJ No   L 270 , 26 . 9 . 1991 , p. 1 .
                                                                                                       Recital 7a
                                                                                                          ( new )
                                                                         Whereas the 'essential requirements' and requirements set
                                                                         out in the Annexes to this Directive , including any reference
                                                                         to 'minimising' or 'reducing' risk must likewise be interpreted
                                                                         and applied in such a way as to take account of technology
                                                                         and practice existing at the time of design and of technical
                                                                         and economical considerations , bearing in mind the
                                                                         relationships between risk and cost and what may reasonably
                                                                         be expected in all circumstances by intended users of medical
                                                                         devices .
                       Twenty-Second Recital                                                    Twenty-Second Recital
Whereas the application of some provisions of this Directive             Whereas the application of some provisions of this Directive
must be facilitated by means of guidelines published by the              must be facilitated by means of guidelines published by the
Commission ;                                                             Commission ; and by making available resources enabling
                                                                         the Commission successfully to carry out information
                                                                         programmes at national level ;
                             Article 1(1 )                                                            Article 1(1 )
 1.     This Directive shall apply to medical devices . It also           1.     This Directive shall apply to medical devices. It also
covers the accessories to which the provisions for medical               covers the accessories to which the provisions for medical
devices apply .                                                          devices apply , particularly the provisions governing the class
                                                                         to which these accessories belong.
                             Article 1 (2)                                                            Article 1 (2 )
( a ) medical device ( hereinafter referred to as 'devices')             ( a ) unchanged
       means any instrument , apparatus , appliance , material
       or other article, including software , whether used alone
       or in combination , intended by the manufacturer to be
       used for human beings solely or principally for the
       purpose of:
 ---pagebreak--- No C 251 / 42                              Official Journal of the European Communities                                       28 . 9 . 92
                           INITIAL TEXT                                                         MODIFIED TEXT
          diagnosis, prevention, monitoring, treatment or                   — diagnosis, prevention, monitoring, treatment or
          alleviation of disease, injury or handicap,                           alleviation of disaese,
                                                                           — diagnosis , monitoring, treatment or alleviation of
                                                                                injury or handicap ,
     — investigation , replacement or modification of the                  — unchanged
          anatomy or of a physiological process ,
     — control of conception ,
     and which does not achieve its principal intended action
     in or on the human body by pharmacological ,
     immunological or metabolic means , but which may be
     assisted in its function by such means ;
(b ) 'accessory' means an article which , while not a device, is      b)    'accessory' means an article which , while not being a
     required , according to the intended purpose attributed               device , is intended specifically by its manufacturer to be
     to it by the manufacturer , to enable the device to be used           used together with a device to enable it to be used in
     as specified ;                                                        accordance with the manufacturer's intentions ;
(g) 'manufacturer' means the natural or legal person with             ( g) 'manufacturer' means the natural or legal person with
     overall responsibility for the design , manufacturing,                responsibility for the design , manufacturing, packaging
     packaging and labelling of a device before it is placed on            and labelling of a device before it is placed on the market
     the market on his own behalf, regardless of whether                   on his own behalf, regardless of whether these
     these operations are carried out by that person himself               operations are carried out by that person himself or on
     or on his behalf by a third party .                                   his behalf by a third party .
     The natural or legal person who assembles , packages ,                The obligations imposed on manufacturers under the
     processes and / or labels one or more ready-made                      terms of this Directive shall also apply to the natural or
     products and / or assigns them to their intended purpose              legal person who assembles , packages , processes and / or
     as a device with a view to their being placed on the                  labels one or more ready-made products and / or assigns
     market on his own behalf is also considered to be a                   them to their intended purpose as a device with a view to
     manufacturer. This sub-paragraph does not apply to the                their being placed on the market on his own behalf. This
     person , who , while not a manufacturer within the                    sub-paragraph does not apply to the person , who , while
     meaning of the first sub-paragraph assembles or adapts                not a manufacturer within the meaning of the first
     devices already on the market to their intended purposes              sub-paragraph , assembles or adapts devices already on
     for an individual patient .                                           the market to their intended purpose for an individual
                                                                           patient .
                          Article 1 (3 )                                                        Article 1 (3)
3.     Where a device is intended to administer a substance           3.      Where a device is intended to administer a substance
defined as a medicinal product within the meaning of                  defined as a medicinal product within the meaning of
Article 1 of Directive 65 / 65 / EEC , that substance shall be        Article 1 of Directive 65 / 65 / EEC , that substance shall be
subject to the marketing authorization system provided for in         subject to the marketing authorization system provided for in
that Directive .                                                      that Directive .
                                                                      If such a device is placed on the market or put into service by
                                                                      the manufacturer separately from the medicinal product, it
                                                                      shall be governed by this present Directive .
 ---pagebreak--- 28 . 9 . 92                                 Official Journal of the European Communities                                 No C 251 / 43
                           INITIAL TEXT                                                          MODIFIED TEXT
                                                                       If, on the other hand , such a device is placed on the market by
                                                                       the manufacturer in such a way that the device and the
                                                                       medicinal product form a single unit, the combined product
                                                                       shall be governed by Directive 65 / 65 / EEC and this present
                                                                       Directive respectively .
                                                                                                    5a ( new )
                                                                       This Directive does not apply to personal protective
                                                                       equipment covered by Directive 89 / 686 / EEC O ). The
                                                                       assessment of whether a product falls under the aforesaid
                                                                       Directive or under this Directive shall in particular take
                                                                       account of the principal intended purpose of the product and
                                                                       where and how it is to be used .
                                                                       (») OJ No L 399 , 30 . 12 . 1989 , p. 18 .
                            Article 10                                                             Article 10
1.      Member States shall take the necessary steps to ensure         1.      unchanged
that any information brought to their knowledge, in
accordance with the provisions of this Directive , regarding
the incidents mentioned below involving a class Ila , lib or III
device is recorded and evaluated in a centralized manner :
( a ) any deterioration in the characteristics and / or                ( a ) any malfunction of or deterioration in the characteristics
      performance of a device , as well as any inaccuracies in               and / or performance of a device as specified by the
      the labelling or the instruction leaflet which might lead              manufacturer , as well as any inaccuracies in the labelling
      to or might have led to the death of a patient or user or to           or the instruction leaflet which might lead to or might
      a serious deterioration in his state of health ;                       have led to the death of a patient or user or to a serious
                                                                             deterioration in his state of health ;
( b ) any technical or medical reason connected with the               ( b ) any technical or medical reason to do with the
      device leading to systematic recall of devices of the same             characteristics or performance of a device leading , for
      type by the manufacturer .                                             the reasons referred to in subparagraph ( a ) above , to
                                                                             systematic recall of devices of the same type by the
                                                                             manufacturer .
                            Article 1 1                                                            Article 1 1
9.      Decisions taken by the notified bodies in accordance           9.      Decisions taken by the notified bodies in accordance
with Annexes II and III shall be valid for a maximum of five           with Annexes II and III shall be valid for a maximum of five
years and may be extended on application for further periods           years and may be extended on application for further periods
of five years .                                                        of five years . These decisions must be conveyed in good
                                                                       time .
                            Article 12                                                             Article 12
1.      Any natural or legal person who assembles devices              1.      Any natural or legal person who assembles devices
bearing the EC mark for their intended purpose and within              bearing the EC mark for their intended purpose and within
the limits of use specified by the manufacturers with regard to        the limits of use specified by the manufacturers with regard to
their compatibility with other devices in order to put them            their compatibility with other devices in order to put them
 ---pagebreak--- No C 251 / 44                              Official Journal of the European Communities                                      28 . 9 . 92
                            INITIAL TEXT                                                         MOD FIED TEXT
on the market in the form of a system , kit or operation pack         on the market in the form of or as part of a system , kit
shall draw up a declaration in which he states that:                  or procedure pack with , when appropriate , any other
                                                                      compatible product shall inform the competent authority
                                                                      in accordance with the provisions of Article 14 that he is
                                                                      engaged in such an activity in general and shall draw up a
                                                                      declaration in which he states that :
( a ) he has verified the mutual compatibility of the devices         ( a ) he has verified the mutual compatibility of the devices
      which make up the system , kit or operation pack in                   and any other products which make up the system , kit or
      accordance with the manufacturers' instructions and                   procedure pack in accordance with any instructions
      that assembly has been carried out in accordance with                 from the manufacturers and that assembly has been
      these instructions ;                                                  carried out in accordance with these instructions ;
( b ) the system , kit or operation pack has , where applicable ,     ( b ) the system , kit or procedure pack has , where applicable ,
      been packaged in accordance with the manufacturers'                   been packaged in accordance with any relevant
      instructions or the limits applicable to the various                  instructions from the manufacturers or the limits
      devices ;                                                             applicable to the various devices or other products as the
                                                                            case may be ;
                             Article 14                                                            Article 14
1.      Any manufacturer who , on his own behalf, places              1.      Any manufacturer who , on his own behalf, places
devices on the market in accordance with the procedures               devices on the market in accordance with the procedures
referred to in Article 11 (4 ) and ( 5 ) shall inform the             referred to in Article 11 (4 ) and ( 5 ) shall inform the
competent authorities of the Member State in which he has             competent authorities of the Member State in which he has
his registered place of business of the address of the registered     his registered place of business of the address of the registered
place of business and the category of devices concerned .             place of business and the designation of the devices
                                                                      concerned .
                             Article 15                                                            Article IS
1.      In the case of devices falling within classes I , Ila and     1.      In the case of devices falling within classes I , Ila and
lib which are intended for clinical investigations , the              lib which are intended for clinical investigations duly
manufacturer, or his authorized representative established in         justified in accordance with the provisions of Annex VIII ,
the Community , shall follow the procedure referred to in             point 2.2 , the manufacturer , or his authorized representative
Annex VIII and keep the statement concerned at the disposal           established in the Community , shall follow the procedure
of the competent authorities .                                        referred to in Annex VIII and keep the statement concerned
                                                                      at the disposal of the competent authorities .
2.      In the cases of devices falling within class III and          2.      In the case of devices falling within class III and
implantable devices falling within class Ila or lib intended for      implantable devices falling within class Ila or lib which are
clinical investigations , the manufacturer, or his authorized         intended for clinical investigations duly justified in
representative established in the Community , shall follow the        accordance with the provisions of Annex VIII , point 2.2 , the
procedure referred to in Annex VIII and, at least 45 days             manufacturer , or his authorized representative established in
before the commencement of the investigations , submit the            the Community , shall follow the procedure referred to in
statement referred to in the abovementioned Annex to the              Annex VIII and , at least 45 days before the commencement
competent authorities of the Member State in which the                of the investigations , submit the statement referred to in the
investigations are to be conducted .                                  abovementioned Annex to the competent authorities of
                                                                      the Member State in which the investigations are to be
                                                                      conducted .
The manufacturer may commence the relevant clinical                   unchanged
investigations at the end of a period of 45 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 .
 ---pagebreak--- 28 . 9 . 92                                      Official Journal of the European Communities                                         No C 251 / 45
                              INITIAL TEXT                                                                MODIF ED TEXT
                                                                            Without prejudice to the power of the competent authorities
                                                                            to take the final decision , there is generally no reason for
                                                                            them to intervene on the basis of the previous subparagraph
                                                                            insofar as the ethics committee concerned has issued a
                                                                            favourable opinion of the programme of investigations in
                                                                            question , referred to in Annex X.
                               Article 17                                                                  Article 17
2.       The EC mark of conformity , as shown in Annex XII ,                2.       unchanged
must appear in a visible, legible and indelible form on the
device , where practicable and appropriate , and / or on the
sales packaging and the instruction leaflet .
It shall be accompanied by the identification number of                     It shall be accompanied by the identification number of
the notified body responsible for implementation of the                     the notified body responsible for implementation of the
procedures set out in Annexes II , IV , V and VI and the last               procedures set out in Annexes II , IV , V and VI .
two digits of the year in which the mark was affixed .
                                                                                                           Article 1 7a
                                                                                                              ( new )
                                                                            The Commission shall take the necessary steps to create and
                                                                            ensure the operation of a Community register containing the
                                                                            necessary information for consistent implementation of this
                                                                            Directive .
                               Article 1 9                                                                 Article 19
2.       In the event of a decision to withdraw devices from the            2.       In the event of a decision referred to in paragraph 1 , the
market , the manufacturer , or his authorized representative                manufacturer , or his authorized representative established
established in the Community , shall have an opportunity                    in the Community , shall have an opportunity to put forward
to put forward his viewpoint in advance , unless such                       his viewpoint in advance , unless such consultation is nqt
consultation is not possible because of the urgency of the                  possible because of the urgency of the measure to be
measure to be taken .                                                       taken .
                               Article 22                                                                  Article 22
3.       The following paragraph 6 is added to Article 1 of                 3.       The definition in Article 1 ( 2 ) ( a ) of Council Directive
Directive 90 /3 85 / EEC :                                                  90 / 385 / EEC shall be replaced by the definition in
                                                                            Article 1 ( 2 ) ( a ) of this present Directive ;
                                                                            Following paragraph 6 is added to Article 1 of Directive
                                                                            90 / 385 / EEC :
    '6 .      The following provisions of Council Directive                     '6 .      The following provisions of Council Directive
         /     / EEC on medical devices also apply to active                         /     / EEC on medical devices also apply to active
    implantable medical devices : Article 1 ( 2) ( g) and ( i);                 implantable medical devices : Article 1 ( 2 ) b ), ( g) and ( i );
    Article 11 ( 6 ), ( 8 ) and ( 9 ); Article 13 ( 1 ) ( c) coupled with       Article 11 ( 6 ), ( 8 ) ad ( 9 ); Article 13 ( 1 ) ( c) coupled with
    Article 7 ; Article 17 ( 3 ); Article 19 ( 2); Article 21                   Article 7 ; Article 17 ( 3 ); Article 19 ( 2); Article 21
    points ( a ) and ( c) of the first paragraph .'                             points ( a ) and ( c) of the first paragraph .'
 ---pagebreak--- No C 251 / 46                             Official Journal of the European Communities                                    28 . 9 . 92
                          INITIAL TEXT                                                        MODIFIED TEXT
                           Article 23                                                           Article 23
4.     In the case of devices which , for the purposes of this       4.     In the case of devices which , for the purposes of this
Directive , must be the subject of one of the procedures             Directive , must be the subject of one of the procedures
referred to in Annexes II to VI , Member States shall accept         referred to in Annexes II to VI , Member States shall accept
the placing on the market and putting into service of devices        the placing on the market and putting into service of devices
which conform to the rules in force in their territory on 30         which conform to the rules in force in their territory on 30
June 1994 during the period up to 30 June 1997 . In the case         June 1994 during the period up to 30 June 1997 . In the case
of other devices lawfully placed on the market before 30 June        of other devices lawfully placed on the market before 30 June
1994 , Member States shall accept their being put into service       1994 , Member States shall accept their being put into service
during the period up to 30 June 1995 .                               during the period up to 30 June 1996 .
                           ANNEX I                                                              ANNEX I
                         Paragraph I                                                          .Paragraph I
1 . The devices must be designed and manufactured in such            1 . The devices must be designed and manufactured in such
    a way that , when used under the conditions and for the              a way that , when used under the conditions and for the
    purposes intended , they will not compromise the clinical            purposes intended , they will not compromise the clinical
    conditions or the safety of the patients , users and , where         condition or the safety of the patients , users and , where
    applicable , other persons . The risks associated with               applicable, other persons , when used under the
    the devices must be reduced to an acceptable level                   conditions and for the purposes intended provided that
    compatible with a high level of protection of health and             any risks which may be associated with their use
    safety .                                                             constitute acceptable risks when weighed against the
                                                                         benefits to the patient and are compatible with a high
                                                                         level of protection of health and safety .
5 . The devices must be designed , manufactured and packed           5 . The devices must be designed , manufactured and packed
    in such a way that their characteristics and performances            in such a way that their characteristics and performances
    during their intended use are not adversely affected in              during their intended use will not be adversely affected
    the storage and transport conditions ( temperature ,                 in the transport and storage taking account of the
    humidity , etc) laid down by the manufacturer.                       instructions and information provided by the
                                                                         manufacturer.
                           ANNEX I                                                              ANNEX I
                         Paragraph II                                                         Paragraph II
7.5 The devices must be designed and manufactured in                 7.5 The devices must be designed and manufactured in
      such a way as to minimize the health risks posed by                  such a way as to minimize risks posed by substances
      substances leaking from the device during use .                      leaking from the device during use .
8.3 Sterile devices must be designed , manufactured and              8.3 Sterile devices must be designed , manufactured and
      packed in a non-reusable pack and / or according to                  packed in a non-reusable pack and / or according to
      appropriate procedures to ensure that they are sterile               appropriate procedures to ensure that they are sterile
 ---pagebreak--- 28 . 9 . 92                                 Official Journal of the European Communities                               No C 251 / 47
                            INITIAL TEXT                                                        MODIFIED TEXT
      when placed on the market and remain sterile , under                  when placed on the market and remain sterile , under
      the storage and transport conditions laid down , until                normal storage and transport conditions as described
       the protective packaging is damaged or opened .                      in the instructions and information supplied by the
                                                                            manufacturer , until the protective packaging is
                                                                            damaged or opened .
11.5 Instruments , apparatus or appliances emitting                    11.5 Devices intended to emit invisible , potentially
         radiation must be fitted with visual displays and / or               hazardous radiation must be fitted with visual displays
         audible warnings of radiation emissions .                            and / or audible warnings of radiation emissions .
12.1 Devices depending on software must be designed in                 12.1 Devices incorporating programmable electronic
         such a way as to minimize the risks arising from errors              systems must be designed in such a way as to avoid so
         in the programmes .                                                  far as reasonably practicable risks arising from
                                                                              random and / or systematic failures .
12.7.5 Accessible parts of the devices and their                       12.7.5 Accessible parts of the devices (excluding any parts
           surroundings must not attain potentially dangerous                   or areas intended to supply heat or attain a high
           temperatures under normal use .                                      temperature) and their surroundings must not attain
                                                                                potentially dangerous temperatures under normal
                                                                                use .
12.8.2 Devices must be fitted with an interlock and / or               12.8.2 Devices must be fitted with means to prevent and / or
           alarm system to prevent and / or indicate any                        indicate any inadequacies in the commanded output
           inadequacies in the flow rate which could pose a                     which could pose a danger .
           danger.
12.9       The function of the controls and visual displays            12.9     The function of the controls and indicators must be
           must be clearly specified on the devices .                           clearly specified on the devices .
13.3       The label must bear the following particulars :             13.3     unchanged
           ( a ) the name or trade name and address of the                      ( a ) unchanged
                 manufacturer :
           ( b ) the details strictly necessary for the user to                 ( b ) unchanged
                 identify the device and the contents of the
                 packaging ;
           (c) where appropriate , the word 'STERILE ;                          ( c) where appropriate, the symbol j STERILE
           ( d) where appropriate , the batch code, preceded by                 (d ) where appropriate, the batch code, preceded
                 the word 'LOT', or the serial number ;                               by the symbol ( LOT I , or the serial number;
 ---pagebreak--- No C 251 / 48                           Official Journal of the European Communities                                   28 . 9 . 92
                         INITIAL TEXT                                                      MODIFIED TEXT
                                                                   13.6a ( new ) The instructions for use shall contain an
                                                                                  explicit request to the user or patient to
                                                                                  inform his / her doctor or medical institution
                                                                                  of any side-effect not referred to in the
                                                                                  instructions for use .
                          ANNEX II                                                           ANNEX II
2 . The declaration of conformity is the procedure whereby         2 . unchanged
    the manufacturer who fulfils the obligations imposed
    by Section 1 ensures and declares that the products
    concerned meet the provisions of this Directive which
    apply to them .
    The manufacturer shall affix the EC mark in accordance             The manufacturer shall affix the EC mark in accordance
    with Article 17 and shall draw up written declaration of           with Article 17 and shall draw up a written declaration
    conformity . This declaration of conformity shall cover a          of conformity . This declaration of conformity shall cover
    given number of identified specimens of the products               a given number of products manufactured on the basis of
    manufactured and shall be kept by the manufacturer .               the approval of the quality system and shall be kept by
    The EC mark shall be accompanied by the identification             the manufacturer .
    number of the notified body which performs the tasks
    referred to in this Annex .
3.1 The manufacturer shall lodge an application for                3.1 unchanged
      assessment of his quality system with a notify body .
      The application shall include :
      — the name and address of the manufacturer,                           unchanged
      — all the relevant information on the product or                      unchanged
          product category covered by the procedure ,
      — a written declaration that no application has been                  a written declaration that no such application has
          lodged with any other notified body for the same                  been lodged with any other notified body for the
          products ,                                                        same products ,
                          ANNEX V                                                            ANNEX V
2 . The declaration of conformity is the part of the               2 . unchanged
    procedure whereby the manufacturer who fulfils the
    obligations imposed by Section 1 ensures and declares
     that the products concerned conform to the type
    described in the EC-type examination certificate and
    meet the provisions of this Directive which apply to
     them .
     The manufacturer shall affix the EC mark in accordance            The manufacturer shall affix the EC mark in accordance
    with Article 17 and shall draw up a written declaration            with Article 17 and shall draw up a written declaration
 ---pagebreak--- 28 . 9 . 92                               Official Journal of the European Communities                              No C 251 / 49
                           INITIAL TEXT                                                      MODIF ED TEXT
     of conformity . This declaration of conformity shall cover          of conformity . This declaration of conformity shall cover
     a given number of identified specimens of the products              a given number of products manufactured on the basis of
     manufactured and shall be kept by the manufacturer .                the approval of the quality system and shall be kept by
     The EC mark shall be accompanied by the identification              the manufacturer .
     number of the notified body which performs the tasks
     referred to in this Annex .
3.1 The manufacturer shall lodge an application for                  3.1 unchanged
       assessment of his quality system with a notify body .
       The application shall include :
       — the name and address of the manufacturer ,                           unchanged
       — all the relevant information on the product or                       unchanged
           product category covered by the procedure,
       — a written declaration that no application has been                   a written declaration that no such application has
           lodged with any other notified body for the same                   been lodged with any other notified body for the
           products ,                                                         same products ,
                           ANNEX VI                                                            ANNEX VI
2 . The declaration of conformity is the part of the                 2 . unchanged
     procedure whereby the manufacturer who fulfils the
     obligations imposed by Section 1 ensures and declares
     that the products concerned conform to the type
     described in the EC-type examination certificate and
     meet the provisions of this Directive which apply to
     them .
     The manufacturer shall affix the EC mark in accordance              The manufacturer shall affix the EC mark in accordance
     with Article 17 and shall draw up a written declaration             with Article 17 and shall draw up a written declaration
     of conformity . This declaration of conformity shall cover          of conformity . This declaration of conformity shall cover
     a given number of identified specimens of the products              a given number of products manufactured on the basis of
     manufactured and shall be kept by the manufacturer .                the approval of the quality system and shall be kept by
     The EC mark shall be accompanied by the identification              the manufacturer .
     number of the notified body which performs the tasks
     referred to in this Annex .
3.1 The manufacturer shall lodge an applicaton for                   3.1 unchanged
       asessment of his quality system with a notified body .
       The application shall include :
       — the name and address of the manufacturer ,                           unchanged
       — all the relevant information on the product or                       unchanged
           product category covered by the procedure ,
       — a written declaration that no application has been                   a written declaration that no such application has
           lodged with any other notified body for the same                   been lodged with any other notified body for the
           products ,                                                          same products ,
 ---pagebreak--- No C 251 / 50                              Official Journal of the European Communities                                  28 . 9 . 92
                        INITIAL TEXT                                                         MODIFIED TEXT
                        ANNEX VIII                                                           ANNEX VIII
2.2 For devices intended for the clinical investigations              2.2 unchanged
    covered by Annex X :
    — data allowing identification of the device in                       — unchanged
        question ,
    — an investigation plan stating in particular the                     — an investigation plan stating in particular the
        purpose , scope and number of devices concerned ,                    purpose , scientific , technical or medical
                                                                             justification , scope and number of devices
                                                                             concerned ,
    — the opinion of the ethics committee concerned and                   — unchanged
        details of the aspects covered by its opinion ,
    — the name of the medical specialist or other                         — unchanged
        authorized person and of the institution responsible
        for the investigations ,
    — the place , starting date and scheduled duration for                — unchanged
        the investigations ,
    — a statement that the device in question conforms to                 — unchanged
        the essential requirements apart from the aspects
        covered by the investigations and that , with regard
        to those aspects , every precaution has been taken to
        protect the health and safety of the patient .
                         ANNEX IX                                                             ANNEX IX
                        Paragraph I                                                          Paragraph I
2.4 Rule 8                                                            2.4 unchanged
    All implantable devices and long-term surgically
    invasive devices are in class lib unless they are
    intended :
    — to be placed in the teeth , in which case they are in               — to be placed in or on the teeth or dental protheses , in
        class Ila ,                                                          which case they are in class Ila ,
    — to be used in direct contact with the heart , the                   — unchanged
        central circulatory system or the central nervous
        system , in which case they are in class III ,
    — to undergo chemical change in the body , to be                       — unchanged
        biologically active, to be wholly or mainly
        absorbed , to supply energy in the form of ionizing
        radiation or to administer medicines , in which case
        they are in class III , except if the devices are placed
        in the teeth .