CELEX: 51995PC0130(02)
Language: en
Date: 1995-04-19
Title: Draft DECISION OF THE EEA JOINT COMMITTEE amending Annex II, technical regulations, standards, testing and certification, to the Agreement on the Europea Economic Area - Draft common position of the Community

COMMISSION OF THE EUROPEAN COMMUNITIES
                                                     Brussels, 19.04.1995
                                                     COM(95) 130 final
                                                       95/0013 (COD)
                                 Proposal for a
         EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE
                    on in vitro diagnostic medical devices
                                     Draft
              DECISION OF THE EEA JOINT COMMITTEE
  amending Annex II, technical regulations, standards, testing and certification,
             to the Agreement on the European Economic Area
                  Draft common position of the Community
                        (presented by the Commission)
 ---pagebreak---                                           -1-
                        EXPLANATOR Y MEMORANDUM
I.   GENERAL CONTEXT
     As part of the programme to complete the internal market, the rules for placing
     medical devices on the market are being harmonized throughout the Community
     to protect patients, users and third parties. Most medical-devices are covered
     already by the Directives on active implantable medical devices (90/385/EEC)1
     and on medical devices (93/42/EEC).2
     In vitro diagnostic medical devices were defined as medical devices in
     Directive 93/42/EEC but, in view of their special nature, were excluded from
     the abovementioned Directives. They are covered by this proposal. "In vitro
     diagnostic medical device" means, essentially, reagents, instruments and
    equipment for examining tissues or substances from the human body for
     medical purposes.
     Unlike medicinal products, which are administered to the*human body, in vitro
     diagnostic devices are used outside the human body for medical examinations of
     samples taken from the patient. These devices are therefore important tools for
     diagnosing illnesses, monitoring patients' state of health, checking the progress
     of courses of treatment and a whole series of other medical applications (for
     example, AIDS, hepatitis and glucose tests, pregnancy tests, tests for congenital
     abnormalities, etc.). Any malfunctioning of these devices could lead to
     misdiagnosis, in some cases with grave consequences for the health and
     treatment of the patients or for third parties who could be infected by contagious
     diseases.
     OJNoL 189,20.7.1990, p. 17.
   , OJNoL 169, 12.7.1993, p. 1.
                                                                                        4
 ---pagebreak---                                       2-
These devices are used mainly by medical laboratories, doctors and
pathologists. A growing proportion, however, are intended to be used by the
patients themselves (for example, glucose or pregnancy tests).
The public interest covered by this proposal concerns the reliability,
performance and precision of the devices in their medical application. In
addition, the Directive provides protection for the health and safety of
professional or private users and third parties against the risks inherent in the
devices.
Unlike the other medical devices already covered by Directives 90/385/EEC
and 93/42/EEC, in vitro diagnostic devices do not usually enter into contact
with the patient. To take account of this unique feature and of the different
risks posed compared with other medical devices, this Directive covers such
devices to complement the existing legislation in this sector.
This proposal for a Directive is based on Article 100a of the Treaty.
Furthermore, it takes into account Article 129 of the Treaty which stipulates
that Community action shall be directed towards the prevention of diseases and
that health protection requirements shall form one constituent part within other
Community policies.
It applies the principles of the new approach to technical harmonization. The
proposal lays down the essential requirements which devices placed on the
market must meet and the conformity assessment procedures with which
manufacturers must comply.
Before drafting this proposal, the Commission ordered a comparative study of
the national legislation on such devices (cf. Section III). Its findings, together
with the broad-based consultations held since 1991 with experts from the
Member States, industrial circles and users, confirmed the need for this
Directive and paved the way for drafting it.
 ---pagebreak---                                        -3-
H. ECONOMIC IMPORTANCE OF THE SECTOR
   Estimates put total worldwide production of medical devices, of which in vitro
   diagnostic devices are one subsector, at ECU 80 billion in 1993 (source: Health
   Industry Manufacturers' Association, HIMA). In 1993 the breakdown of
   production by country of origin was as follows: USA 52%; EC + EFTA 28%
   (EC 26%); Japan 18%. Since 1990 consumption has grown by 6% per year in
   the Community (by 7% in the USA in 1993 and by 6% in Japan).
   Some 50% of the Community market is supplied by the Community's own
   producers, 43% by US makers and 5% by Japanese manufacturers. In 1993 the
   estimated number of jobs provided by this industry in the EC stood at over
   240 000.
   Research is particularly important to the performance of this sector. According
   to sources in the industry, an average of 5.9% of its turnover is invested in
   research (EC 5%; USA 6.7%; Japan 6%).
   The in vitro diagnostic medical device subsector covered by this proposal
   accounts for between 16% and 18% of the total medical device market. This
   amounted to a total world market in these devices of some ECU 12.2 billion in
   1992 (source: European Diagnostics Manufacturers' Association, EDMA). In
   1992 the EC/EFTA took ECU 4.6 billion of this market, giving them a world
   market share of 38% (USA 39%; Japan 12%).
   European industry is highly developed in this subsector. It holds an extremely
   competitive position on the world market. An estimated 400 or so businesses,
   most of them medium-sized, are active in this field in the EC and EFTA
   countries. . Germany is the largest producer in Europe. France, the
   United Kingdom, Italy, Belgium and the Netherlands also have major
   industries..
 ---pagebreak---                                        -4-
   In vitro diagnostic medical device technology has developed rapidly over the
   last thirty years.
   The success of the technology is due, in particular, to the progress made with
   the development of scientific methods of analysis in the fields of chemistry,
   biochemistry and immunology, to the increase in the biological parameters
   available and to the combination of these data and methods with
   microelectronics, automation and information technology. Research activity in
   this industry is above average for the sector. Research accounts for between 15
   and 20% of the jobs in this subsector.
m. LEGISLATION ON IN VITRO DIAGNOSTIC MEDICAL DEVICES AND
   EVALUATION OF THE NEED FOR LEGISLATION
1. Existing legislation
   Before starting the harmonization work, in 1991 the Commission conducted a
   study to compare and analyse several Member States' national legislation on this
   subject. This revealed that the Member States' legislation differed not only in
   terms of the products covered but also on the detailed rules and the level of
   protection. Moreover, most of the legislation did not cover all the reagents,
   instruments, equipment and complete complex systems used for biomedicine,
   for which legislation is needed to provide an appropriate level of protection of
   health and safety.
 ---pagebreak--- Based on the abovementioned study, the current situation as regards the
Member States' legislation can be summed up as follows:
*      Some Member States have no legislation specifically on in vitro
       diagnostic devices, except on selected products which are particularly
       sensitive from the public health point of view. This is the case in the
       United Kingdom, Spain, Italy and the Netherlands where, in essence,
       tests to detect AIDS (HIV), tests on blood intended for transfusions or a
       few other specific reagents are monitored by the public authorities or
       subjected to special regulatory procedures before they can be placed on
       the market.
*      France recently adopted new legislation introducing a registration
       procedure to check the performance of reagents before they are placed
       on the market. Further inspections are required for certain categories of
       devices such as HIV tests, tests to determine blood groups and
       radioimmunoassays.
*      Belgium applies some of the rules for medicinal products to in vitro
       reagents too. c
*      In Germany the devices in question are governed by various regulations
       which call for stringent monitoring of some of them. Reagents are
       classified as medicinal products and are subject to controls calling for the
       application of good manufacturing practice. Several other groups of tests
       (immunological tests, particularly HIV tests, tests for hepatitis and tests
       for venereal diseases) have to pass an authorization procedure before
       they can be placed on the market. In addition, laboratory instruments
       and equipment used in this field are covered by the legislation on
        metrology and product safety.
In conclusion, the study revealed big differences between the requirements
imposed on the devices by the national regulatory systems, particularly with
regard to labelling, authorization or registration procedures and production
control.
 ---pagebreak---                                     -6-
In the USA, the Community's leading trading partner and the biggest producer,
in vitro diagnostic devices (reagents, laboratory instruments and equipment for
biomedicine) have been governed by the legislation on medical devices since
1976. A series of special rules on, for example, labelling, manufacturing, etc.
take account of the specific nature of these devices. The rules on good
manufacturing practice are compulsory.
2.      European standardization
        Work already done by the European standardization bodies
        CEN/CENELEC will smooth the way for implementation of the future
        Community legislation. A number of "horizontal" standards on medical
        devices in general also apply to in vitro diagnostic devices and more
        specific work has been carried out on, for example, the information
        which must be supplied to users or on laboratory equipment. Some of
        this work has already been started in anticipation of this Directive.
3.      Evaluation of the need for harmonization
        There is a danger that the current differences between the national
        regulatory systems could deepen in the future. In particular, several
        Member States have already begun to legislate on in vitro diagnostic
        devices, notably when reorganizing their national legislation to
        implement Directives 90/385/EEC and 93/42/EEC on medical devices.
 ---pagebreak---                                      -7-
        This has been confirmed by the cases of application or non-application of
        Directive 83/189/EEC on the notification of draft technical regulations.3
        Under this procedure the Commission has received notification of
         several national regulations concerning, in particular, the introduction of
         monitoring arrangements for HIV and hepatitis tests or for other tests
         (immunological and cancer tests). In one case the Commission had to
        apply Directive 83/189/EEC to block a draft national technical -
        regulation for one year pending this proposal.
The current disparities between the national systems, plus those which would
follow with the adoption of further national legislation in the absence of
European harmonization, create barriers to the free movement of these devices
in the Community. The diverging requirements applied with regard to the
devices covered and the monitoring procedures make it virtually impossible to
establish any equivalence between the various national provisions in terms of
health protection. For this reason, application of the principles of mutual
recognition based on Article 30 of the Treaty/will be insufficient and
inappropriate for removing and preventing barriers in this sector. Establishment
of European standards by the CEN/CENELEC alone, without a regulatory
framework, will not be enough to remedy the situation described above, given
the voluntary nature of the standards. Consequently, harmonization of the
legislation is the most appropriate means of ensuring free trade, all the more so
since such Community legislation already exists for most other medical devices.
OJ No L 109, 26.4.1983, p. 8, as last amended by Directive 94/10/EC of the
European Parliament and the Council, OJ No L 100, 19.4.1994, p. 30.
                                                                                     A
 ---pagebreak---                                       -8-
  From the economic point of view, there is a danger that the lack of harmonized
  legislation could hamper the development of this industry in the Community.
  The diverging regulations force manufacturers to adapt their products to the
  situation on the individual national markets. They are therefore unable to
s benefit from the Community market as their internal market. By contrast,
  harmonized conditions for placing products on the market would enable them to
  achieve economies of scale. Also, once manufacturers have adapted their
  products and processes to the Community legislation, they can expect the
  harmonization of legislation to cut the costs of complying with the regulations
  whicl\ are higher at the moment because of the need to comply with the varying
  national systems and procedures.
  The introduction of Community legislation taking account of the specific nature
  of the devices in question will generate added value for the development of the
  European industry and enable it to benefit more fully from the dimension of the
  internal market.. In contrast to the current situation, such legislation will create
  stable, foreseeable regulatory conditions and at the same time encourage the
  industry to proceed with research and make the necessary investments. In this
  way, it will contribute towards making the European industry more competitive
  on the world market.
  Finally, the Cqmmunity legislation will have an impact on trading relations with
  non-Community countries. Once this proposed Directive has been adopted, the
  Community will be able to use it in its international negotiations to improve
  access for the European industry to markets in third countries.
 ---pagebreak---                                         -9-
    Since 1991 the Commission has organized several meetings to consult experts
    from the Member States, the industry and users on the results of the
    comparative analysis of the legislative systems in a number of Member States
    and the evaluation of the need for harmonization of the legislation and the
    content thereof* The conclusions drawn confirmed the Commission's view that,
    in view of the big differences between the national systems, of the obstacles to
    free trade and of their negative impact on industrial activity on the European
    market, harmonization of the legislation is necessary and will provide added
    value, both for protecting health and for the activities of the European industry
    concerned. In particular, all concerned have recognized the need for
    harmonization of the legislation. The consultations also showed that, as far as
    possible, this harmonization must complement and follow the same lines as the
    harmonization already completed for other medical devices.
IV. JUSTIFICATION IN THE LIGHT OF THE SUBSIDIARITY PRINCIPLE
1.  What are the objectives of the proposed action in relation to the Community's
    obligations?
    As explained in Section III, the objective of this proposal for a Directive is:
    *    to ensure free movement of in vitro diagnostic medical devices by
        harmonizing the national legislation on protection of the health and safety
        of patients, users and third parties;
    *    to complete the existing Community legislation provided by
        Directives 90/385/EEC and 93/42/EEC on medical devices and to apply the
        same principles to in vitro diagnostic devices;
    *    to create a favourable environment with uniform conditions of competition
         to enable the industry to benefit from the scale of the European Economic
        Area and to help make European industry more competitive.
 ---pagebreak---                                       - 10 -
2. Does competence for the planned activity lie solely with the Community?
   Exclusive competence, under Article 100a in conjunction with Article 7a of the
   Treaty.
   What forms of action are available to the Community?
   In view of the objectives of removing the barriers created by the diverging
   regulatory systems, of preventing new barriers and of establishing, a uniform,
   stable and foreseeable legal framework to protect the public interests concerned,
   the introduction of Community legislation is necessary. It must cover the
   manufacturing conditions, the protection requirements imposed on the devices,
   the conformity assessment procedures and the arrangements for monitoring the
   market. A Directive is the most appropriate instrument. As far as possible, the
   Directive will have to follow the principles already adopted for the rest of the
   industry in Directives 90/385/EEC and 93/42/EEC.
   Is it necessary to have a uniform regulation or is a Directive setting out the
   general objectives sufficient, leaving implementation at the level of the
   Member States ?
   A new approach Directive is proposed. It is confined to laying down the
   essential safety and performance requirements to be met by devices placed on
   the market and refers to voluntary European standards to be established by the
   CEN/CENELEC for technical formulation of these requirements. At the
   administrative level, implementation is reserved for the Member States. They
   will be responsible for monitoring the market and cooperating with the
   authorities in the other Member States. They will also appoint the certification
   bodies (notified bodies), depending on the availability of suitably qualified
   bodies, and monitor their activities.
 ---pagebreak---                                        -11-
V. CONTENT OF THE PROPOSAL
1. Scope
   This proposal for a Directive governs the conditions for placing in vitro
   diagnostic medical devices on the market. It lays down the essential
   requirements in terms of the reliability of the devices, bearing in mind their
   intended purpose as tools for diagnostics and medical monitoring, and in terms
   of protection of users and third parties. The Directive also harmonizes the
   conformity assessment procedures to be applied by manufacturers before placing
   the devices on the market. The CE marking must be affixed to devices
   conforming with the requirements, which will be allowed to move freely
   throughout the internal market.
   In vitro diagnostic medical devices are a subcategory of medical devices, as
   already defined in Directive 93/42/EEC. They are devices used in medicine for
   the in vitro analysis of specimens from the human body. The medical
   applications include analyses of state of health (cholesterol or pregnancy tests),
   of diseases or congenital abnormalities, monitoring progress with a course of
   treatment (for example, dose and effect of medicinal products) or the
   establishment of compatibility in cases of organ or blood donations (for
   example, HIV and hepatitis tests).
   The vast majority of the products covered are intended for professional users,
   i.e. reagents, kits, instruments and equipment specifically for medical
   laboratories. The Directive also includes devices for self-testing which are used
   by patients or consumers in the home environment, for which it lays down
   special requirements to ensure that these devices can be easily used correctly by
   users with no particular knowledge of biological analysis.
                                                                                      U
 ---pagebreak---                                          -12-
     Control material and calibrators intended for use in combination with the
     abovementioned reagents and equipment are also considered to be in vitro
     diagnostic devices.
     The Directive will cover laboratory equipment only where it is Specifically
     intended for use in medical laboratories conducting in vitro examinations.
     The proposal does not apply to devices, in particular reagents, manufactured by
     laboratories for their own needs without any transaction with other users. It is
     left to the discretion of the Member States whether to require the appropriate
     monitoring for such activities.
2.   Essential requirements
     Devices placed on the market must comply with the essential requirements set
     out in Annex 1 to ensure a high level of protection of health and safety. They
     must be designed and manufactured to achieve the performances stated by the
     manufacturer and for use for the intended medical purpose, taking account of
     the generally acknowledged state of the artvThe essential requirements are also
     designed to protect users and third parties in particular against the risks posed
     by the physical and chemical properties of the devices and against the
     biological, mechanical, thermal, electrical and radiation risks posed by any
     energy source with which they are equipped. Devices for self-testing must be
     designed taking into account the skills and means available to users. Particular
   * attention must be paid to the clarity of the information and instructions
     accompanying the devices.
 ---pagebreak---                                       - 13 -
3. Conformity assessment procedures
   The conformity assessment procedures are based on Council Decision
   90/683/EEC,4 as amended by Council Decision 93/465/EEC.5 The proposal is
   aligned on the wording for these procedures in Directive 93/42/EEC, taking
   account of the specific nature of in vitro diagnostic medical devices and of
   manufacture thereof.
   (a)    Devices placed on the market solely on the manufacturer's responsibility
          For an extremely large proportion of these devices, Article 9 and Annex
          3 of the proposal provide for the design and manufacture stages to be
          monitored on the manufacturer's responsibility, without the intervention
          of any third party. In view of the requirements imposed in order to
          control production and obtain products of reliable quality, manufacturers
          must follow the principles of quality assurance as appropriate for the
          devices manufactured. In addition, the technical documentation provided
          by the manufacturer must contain, inter alia, proof of the manufacturer's
          evaluation of the performance.
   (b)    Devices requiring the intervention of a notified body
          Provision is made for the intervention of a notified body before devices
          for self-testing (Annex 3, point 6) and various categories of devices
          specified in Annex 2 are placed on the market.
   OJNoL380, 31.12.1990, p. 13.
   OJNo L 220, 30.8.1993, p. 23.
 ---pagebreak---                               14-
In the case of devices for self-testing, the intervention of a notified body
is necessary as these devices are normally intended for persons with no
experience of using them. For this reason, the notified body must
concentrate on verification and on the performance of the devices under
the conditions in which they would normally be used, taking account of
the intended users.
For the categories specified in Annex 2, i.e. tests for blood grouping and
for the detection of HIV and hepatitis, Article 9 and Annexes 4, 5, 6 and
7 provide for procedures requiring the intervention of a notified body.
The notified bodies will certify the design and manufacture of such
devices. In accordance with Decision 90/683/EEC on the certification
modules, manufacturers may choose between product certification
(Annexes 5 and 6), evaluation of the full quality assurance system
(Annex 4) or an approach combining a type examination with a certified
production quality assurance system (Annexes 5 and 7).
These stringent procedures are-warranted by the fact that the tests in
question are used particularly in the context of blood transfusions or
organ transplants. Consequently, strict controls on these devices are
essential to ensure reliable diagnosis. Moreover, HIV tests are targeted
on AIDS, which must be combated with the most appropriate, effective
means available in the interest of public health.
 ---pagebreak---                                   - 15 -
(c)  Classification arid reclassification of devices
    The proposal allows amendment of the list of devices in Annex 2, with
    the assistance of a regulatory committee (cf. Article 12). This
    reclassification procedure could prove necessary, particularly where
    devices for new uses cannot provide sufficient guarantees of the
    reliability of their performance. In such cases, verification by a third
    party could be necessary on health protection grounds.
    For this reason, depending on their intended medical use, performance
    or characteristics, certain categories of device could, if necessary, be
    subjected to the appropriate conformity assessment procedures within the
    framework of this proposal. The rules on the conformity assessment
    procedures are a balanced reflection of the existing national legislation in
    this field. By reserving conformity assessment for a large proportion of
    devices for the manufacturers, the proposal takes account of the fact that
    these devices are intended for professional users. In addition, in most
    Member States-medical laboratories in turn are subject to outside quality
    assurance systems which will offer added controls.
    Finally, the proposal provides for mechanisms to monitor the market,
    notably via vigilance procedures. If application of these mechanisms
    indicates a need to tighten up the controls before certain devices are
    placed on the market, reclassification may be decided following the
    committee procedures.
 ---pagebreak---                                -16-
4. Registration of manufacturers and vigilance procedure
   Article 10 of the proposal requires all manufacturers to inform the
   competent authorities of the Member State where they have their
   registered place of business of the categories of devices which they
   market. Manufacturers not established in the Community must designate
   an authorized representative to carry out the abovementioned
   notification. Notification is also required for new devices, as specified
   in the proposal. These rules enable the authorities to monitor the market
   and to take any measures necessary to protect the public interest. A
   network linking the authorities will therefore have to be established to
   make it easier to exchange data. Just as for the other medical devices
   covered by Directives 90/385/EEC and 93/42/EEC, this proposal
   introduces a vigilance procedure (Article 11). Under these rules,
   manufacturers will have to give notification of any malfunction of the
   devices which could affect patients' and users' health. The objective of
   this vigilance system is to prevent devices from remaining in circulation
   on the Community market if they display faults which could lead to the
   wrong medical decisions. This system reinforces the monitoring
   methods at the disposal of the competent authorities and encourages
   manufacturers to conduct the requisite investigations and make the
   necessary corrections to the devices concerned. Close cooperation
   between the national administrations will be essential in this system.
   Special arrangements for devices for performance evaluation
   Article 9(3) of the proposal makes special arrangements for in vitro
   diagnostic medical devices for performance evaluation. These apply to
 ---pagebreak---                                17-
devices intended for medical use of which the precise performance has
yet to be verified and confirmed. In view of the objective of the
evaluations, there is no need for such devices to comply with all the
essential requirements. The status of these devices must be indicated on
the label and the manufacturer must follow a special conformity
procedure.
Amendments to Directive 93/42/EEC concerning medical devices
These amendments (Article 19(1)) concern the definition of "in vitro
diagnostic medical device" in Directive 93/42/EEC. They would also
extend the scope of Directive 93/42/EEC by adding devices
incorporating tissues of human origin. At the time of the adoption of the
Directive concerning medical devices, the Council asked the
Commission to reexamine the situation with these devices and to propose
the measures to be taken. Preparatory work on this subject has revealed
that, at national level, either there is no legal cover for such devices or
that they are governed by diverging classifications which could impair
free movement. In view of the current legal uncertainty and of the
inherent health hazards posed by these devices, the majority of the
national experts recognize the need to make such devices subject to
Directive 93/42/EEC. However, Directive 93/42/EEC will apply only
to devices incorporating tissues which have been rendered non viable.
The proposal will apply without prejudice to the national regulations
relating to the ethics of collecting and using tissues of human origin,
thereby taking account of the concerns expressed during the consultation
phase.
 ---pagebreak---                                         -18-
            Similar problems with the inclusion of devices incorporating tissues of
            human origin also arise in the case of in vitro diagnostic devices
            (including in the form of control materials in kits). Consequently, the
            proposed amendment to Directive 93/42/EEC will result in uniform rules
            for the entire sector.
VI. RELEVANCE TO THE EUROPEAN ECONOMIC AREA
    This proposal falls into the field covered by the Agreement on the European
    Economic Area. The consultations included experts from the EFTA countries
    in the EEA. The proposal for a decision by the EEA Joint Committee
    extending the proposal for a Directive to the EEA is included in this dossier.
                                                                                    12
 ---pagebreak--- PROPOSAL FOR A DIRECTIVE OF THE EUROPEAN PARLIAMENT
                  AND THE COUNCIL
       ON IN VITRO DIAGNOSTIC MEDICAL DEVICES
 ---pagebreak---                                    -2
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community,
and in particular Article 100a thereof,
Having regard to the proposal from the Commission1,
Having regard to the opinion of the Economic and Social Committee2,
Acting in accordance with the procedure referred to in Article
189B of the Treaty establishing the^. European Community,
Whereas   measures    should    be    adopted   for the   progressive
establishment of the internal market; whereas the internal market
is an area without internal frontiers in which the free movement
of goods, persons, services and capital is ensured;
Whereas the content and scope of the laws, regulations and
administrative provisions in force in the Member States with
regard   to   the   safety,    health    protection and   performance
characteristics   and    authorization procedures     for  in vitro
diagnostic medical devices are different; whereas the existence of
such disparities constitute barriers to trade and the need to
establish harmonised rules was confirmed by a comparative survey
of national legislations carried out on behalf of the Commission;
 ---pagebreak--- Whereas the harmonization of national legislations is the only
means of removing these barriers to free trade and preventing new
barriers; whereas " this objective cannot be achieved in a
satisfactory manner at another level by the individual Member
States; whereas this Directive only lays down necessary and
sufficient requirements for the free circulation of the in vitro
diagnostic medical devices to which it is applicable;
Whereas tl\e harmonized provisions must be distinguished from the
measures adopted by the 'Member States to manage the funding of
public health and sickness insurance schemes relating directly or
indirectly to such devices; whereas, therefore, the provisions do
not affect the ability of the Member States to implement the
abovementioned measures provided Community law is complied with;
Whereas in vitro diagnostic medical devices should provide
patients, users and third parties with a high level of protection
and attain the performance levels attributed to them by the
manufacturer; whereas,' /therefore, the maintenance or improvement
of the level of protection attained in the Member States is one of
the essential objectives of this Directive;
 ---pagebreak---                                            -4-
Whereas,   in accordance with the principles               set out in the        Council
resolution    of   7 May     1985   concerning     a new    approach     to   technical
                                            3
harmonization     and standardization ,          rules regarding       the design    and
manufacture      of     relevant      products     must     be    confined      to   the
provisions    required      to meet     the   essential    requirements;       whereas,
because   they    are   essential,      such   requirements      should    replace   the
corresponding         national      provisions;        whereas       the      essential
requirements, including requirements to minimize and reduce risks,
should    be    applied      with    discretion,      taking      into   account     the
technology and practice at the time of design and of'technical and
economic considerations compatible with a high level of protection
of health and safety;
Whereas   the major      part   of medical      devices    are   covered    by   Council
Directive     90/385/EEC        relating      to   active      implantable       medical
devices 4  and    Council     Directive      93/42/EEC    relating      to   all   other
                    1
medical devices-"      with the exclusion of in vitro diagnostic                 medical
devices;    the   present     Directive     shall   extend    the   harmonization     to
in vitro    diagnostic medical         devices; whereas,        in   the   interest   of
uniform   Community       rules,   this   Directive     is   based    largely    on  the
provisions of Directives 90/385/EEC and 93/42/EEC;
Whereas   certified      international      reference    materials      and   materials
used  for    external     quality    assessment     schemes     are   not   covered   by
this  Directive,       calibrators      and   control   materials      needed    by  the
user to establish        or verify performances          of devices      are   in  vitro
diagnostic medical devices;
   OJNo.C 136.4.6.1985. p. I
   OJ NoL 189. 20.7.1990. p. I 7
   OJNo. L 169, 12.7.1993. p. 1
 ---pagebreak---                                                    D-
Whereas reagents produced within user laboratories and which are
not subject to commercial transactions, taking account of the
principle of subsidiarity, are not included in this Directive;
Whereas the electromagnetic compatibility aspects form an integral
part of.the essential requirements of this- Directive, the Council
Directive* 89/336/EEC of 3 May 1989 relating to electromagnetic
compatibility 6 shall not apply;
Whereas, in order to ease the task of proving conformity with the
essential requirements and to enable conformity to be verified, it
is desirable to have harmonized standards in respect of the
prevention of risks associated with the design, manufacture and
packaging of medical devices; whereas such harmonized standards
are drawn up by private-law bodies and should retain their status
as non-mandatory texts; whereas, to this end, the European
Committee for Standardization (CEN) anpl the European Committee for
Electrotechnical Standardization (CENELEC) are recognized as the
competent bodies for the adoption of harmonized standards in
accordance, with the general guidelines on cooperation between the
Commission and these two bodies signed on 13 November 1984;
Whereas, for the purpose of this Directive, a harmonized standard
is a technical specification (European standard or Harmonization
Document) adopted, on a mandate from the Commission, by either or
both .of these bodies in accordance with Council ^ Directive
83/189/EEC of 28 March 1983 laying down a procedure for the
provision of information in the field of technical standards and
regulations7,           and      pursuant         to      the   abovementioned        general
guidelines;
6   OJ No. L 139, 23.5.1989. p. 19. Directive last amended by Directive 93/68/EEC (OJ No. L 220,
    30.8.1993, p. 1)
7
    OJ No. L 109, 26.4.1983, p. 8. Directive last amended by Directive 94/10/EC of the European
    Parliament and the Council (OJ No. L 100, 19.4.1994. p. 30)
 ---pagebreak--- Whereas, in- Decision 90/683/EEC of 13 December 1990 concerning the
modules for the various phases of the conformity assessment
procedures        which        are intended to be used in the technical
harmonization directives8, the Council has laid down harmonized
conformity assessment procedures; whereas the details added to
these modules are justified by the nature of the verification
required for in vitro diagnostic medical devices and by the need
for consistency with the previous directives on medical devices;
Whereas it is necessary, essentially v for the purpose of the
conformity assessment procedures, to group in vitro diagnostid.
medical devices into two product classes; whereas, since the large
majority of such devices do not constitute a direct risk to
patients and are used by competently trained professionals, and
the results obtained can often be confirmed by other means, the
conformity assessment procedures can be carried out, as a general,
rule, under the sole responsibility of the manufacturer; whereas,
taking     account        of      existing         national         regulations        and       of
notifications received following the procedure of Directive
83/189/EEC, the intervention of->•• natifled bodies is needed only for
defined devices,, t'he correct performance of which is essential to
medical practice and the failure of which can cause a serious risk
to health;
   OJ No. L 380, 31.12.1990, p. 13, as last amended by Decision 93/465/EEC, OJ No. L 220, 30.8.1993,
   p. 23
 ---pagebreak---                                       -7-
Whereas the list of in vitro diagnostic medical devices to be
subjected to third party conformity assessment needs updating,,
taking account of technological progress and of evolution in the
domain of protection of health; whereas such updating measures
must be taken in line with the procedure Ilia as laid down in the
Council Decision 87/373/EEC9; whereas a system of adverse incident
reporting     (vigilance)      constitutes a useful tool   for   the
surveillance of the market, including the performance of new
devices; whereas information obtained from vigilance as Well as
from external quality assessment schemes becomes useful for
decision-making on classification of devices;
Whereas medical devices should, as a general rule, bear the CE
marking to indicate their conformity with the provisions of this
Directive to enable them to move freely within the Community and
to be put into service in accordance with their intended purpose;
Whereas manufacturers shall have the possibility,         when the
intervention of a notified body is required, to choose amongst
those bodies published by the Commission; whereas the Member
States do' not have an obligation to designate such notified
bodies, they must ensure however that bodies designated as
notified bodies comply with the assessment criteria laid down in
this directive;
Whereas the competent authorities in charge of market surveillance
must be able, particularly in emergencies, to contact            the
manufacturer or his authorized representative established in the
Community; whereas cooperation and exchange of information between
Member States are necessary in view of uniform application of this
Directive, in particular for the purpose of market surveillance;
   OJno. L 197. 18.7.1987. o. 23
 ---pagebreak---                                 -8-
Whereas this Directive includes •in vitro diagnostic medical
devices incorporating substances derived from the human body, it
does not affect national regulations relating to the ethics of use
of such substances; whereas for the purpose of overall consistency
between medical devices directives, the Directive 93/42/EEC needs
to be amended accordingly;'
HAVE ADOPTED THIS DIRECTIVE :
 ---pagebreak---                         Article 1
                    Scope, Definitions
This Directive shall apply to in vitro diagnostic medical
devices and their accessories. For the purposes of this
Directive, accessories shall be treated as in vitro
diagnostic medical devices in their own right. Both in vitro
diagnostic medical devices and accessories shall hereinafter
be termed devices.
For the purpose of this Directive, the following definitions
shall apply :
(a)  "medical device" means any instrument, apparatus,
     appliance, material or other article,- whether used alone
     or in combination, including the software necessary for
     its proper application intended by the manufacturer to
     be used for human beings for the purpose of :
         diagnosis, prevention,    monitoring,   treatment  or
         alleviation of disease,
         diagnosis, monitoring, treatment, alleviation      or
         compensation for an injury or handicap,
         investigation, replacement or modification     of the
         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;
 ---pagebreak---                                  -10-
(b) "in vitro     diagnostic medical       device" means          any    medical
    device which      is a reagent, reagent product,               calibrator,
    control material,        kit,   instrument,     apparatus,        equipment
    or system whether used alone or in combination,                    intended
    by   the    manufacturer       to  be   used     in     vitro      for    the
    examination      of   specimens     including      blood       and    tissue
    donations,      derived     from   the   human      body,       solely     or
    principally      for   the    purpose   of   providing         information
    concerning     a    physiological     state,     state      of   health    or
    disease    or   congenital     abnormality     or    to    determine      the
    safety and compatibility with potential recipients.
    For the purpose of this directive, a specimen receptacle,
    whether    evacuated     or not,    specifically       intended      by   its
    manufacturer to contain a specimen for the purpose of in
    vitro    diagnostic      examination     is    considered         to   be   a
    device;
    Products     for   general     laboratory     use    are     not     devices
    unless   such products, in view of their               characteristics,
    are   specifically     'intended   by   their    manufacturer         to   be
    used for in vitro diagnostic examination;
(c) "accessory" means        an article which, whilst            not    being   a
    device    in   the   meaning    of  paragraph      2 ( b ) , is    intended
    specifically      by   its   manufacturer      to   be     used    together
    with   a   device     to   enable   this    device      to    be   used    in
    accordance with its intended purpose;
(d) "Device    for   self-testing" means       any    device      intended     by
    the manufacturer to be used in the home environment;
 ---pagebreak---                            -li-
 fe) "Device for performance    evaluation" means   any  device
     intended by the manufacturer to be subject to one or
     more   performance   evaluation    studies  in    clinical
     laboratories   or  in * other   appropriate  environments
     outside his own premises;
 (f) "manufacturer" means the natural. or legal person with
     responsibility for the design, manufacture, packaging
     and labelling of a device before it is placed on the
     market under his own name, regardless of whether these
     operations are carried out by thafr person himself or on
     his behalf by a third party.
     The obligations of this Directive to be met by
     manufacturers also apply to the natural or legal person
     who assembles, packages, processes, fully refurbishes
     and/or labels one or more ready-made products . and/or
     assigns to them their intended purpose as devices with a
     view to their being placed on the market, under his own
     namej
(g)  "authorized representative" means the natural . or legal
     person established within the Community who, being
     explicitely designated by the manufacturer, acts and may
     be addressed by authorities and bodies in the Community
     in substitution for the manufacturer, with regard to the
     latter's obligations in accordance with this Directive.
(h)  "intended purpose" means the use for which the device is
     intended according to the data supplied by the
     manufacturer on the labelling, in the instructions for
     use and/or in promotional materials;
 ---pagebreak---                             -12-
(i)   "placing on the market" means the first making available
      in return for payment or free of charge of a device with
      a view to distribution and/or use on the Community
      market, regardless of whether it is new or fully
      refurbished;
(j)   "putting into service" means the stage at which a device
      is ready for use on the Community market for the first
      time for its intended purpose;
(k)   "calibrator", "control material" mean any substance,
      material or article intended , by its manufacturer to
      establish and/or verify performance characteristics of a
      device in conjunction with the use of" that device;
 Where à device incorporates tissues or substances of human
 origin, this directive shall not affect national regulations
 relating to the ethics of the collection of tissues or
 substances of human origin       as well as any regulations
 relating to the ethics governing distribution of given types
 of devices of such origin.
 ---pagebreak---                                                  -13-
4.    This Directive shall not apply to devices manufactured and
      used only within the same institution and on the premises of
      their manufacture. This does not^affect the right of Member
      States to subject such activities to appropriate protection
      requirements.
5.    This Directive is a specific directive within the meaning of
      Article 2(2) of the Directive 89/336/EEC10..
                                           . Article 2
               Placing on the market and putting into service
      Member States shall take all necessary steps to ensure that
      devices may be placed on the market and put into service only
      if they comply with the requirements laid down in this
      Directive when properly installed, maintained and used in
      accordance with their intended purpose.
                                            Article 3
                                  Essential requirements
      Devices must meet the essential requirements set out in Annex
      1 which apply to them, taking account of the intended purpose
      of the devices concerned.
10 Council Directive 89/336/EEC relates to electromagnetic compatibility. OJ No. L J39, 23.5.1989, p. 19;
   as last amended by Directive 9 3 / 68 /EEC (OJ n o L 2 2 0 , 3 0 . 8 . 1 9 9 3 , p . 1)
                                                                                                          i \
 ---pagebreak---                                -14-
                            Article 4
                          Free movement
   Member States shall not create any obstacle to the placing on
   the market or the putting into service within their territory
   of devices bearing the CE-marking provided for in article 14
   or labelled as devices for performance evaluation if these
   devices have been the subject of an assessment of their
   conformity in accordance with the provisions of article 9.
2. At trade fairs, exhibitions, demonstrations, Member States
   shall not create any obstacle to the showing of devices which
   do not conform to this Directive, provided that a visible
   sign clearly indicates that such devices cannot be marketed
   or put into -service until they have been made to comply.
3. Member States may require, when a device reaches the final
   user, information, as referred to in Annex 1 point 13, to be
   in their national       language(s) or in other Community
   language (s) to the extent that it is needed for safe and
   correct use of the device. In the application of this
   provision Member States shall take into account the principle
   of proportionality and in particular whether information can
   be provided by recognised symbols or codes and whether the
   device is intended for use by trained professionals.
 ---pagebreak---                               -15-
4. Where the devices are subject to other Directives concerning
   other aspects and which also provide for the affixing of the
   CE marking, the latter shall indicate that the devices also
   fulfil the provisions of the other Directives.
   However, should one or more of these directives allow the
   manufacturer, during a» transitional period, to choose which
   arrangements to apply, the CE marking shall indicate that the
   devices fulfil the provisions only of those directives
   applied by the manufacturer. In this case, the particulars of
   these directives, as published in the Official Journal of the
   European Communities, must be given in the documents, notices
   or instructions required by the directives and accompanying
   such devices.
                           Article 5
                     Reference to standards
I9 Member States .shall presume compliance with the essential
   requirements referred to in Article 3 in respect of devices
   which are in conformity with the relevant national standards
   which transpose the harmonized standards the reference of
   which have been published in the Official Journal of the
   European Communities; Member States shall publish the
   references of such national- standards
   /If the Member State or the Commission considers that the
   harmonized standards do not entirely^ meet the essential
   requirements referred to in Article 3, the measures to be
   taken with regard to these standards and the publication
   referred to in paragraph 1 of this Article shall be adopted
   by the procedure defined in Article 6(2)
 ---pagebreak---                              • - 16-
                           Article 6
        Committee on Standards and Technical Regulations
1. The Commission shall be assisted by the Committee set up by
   Article 5 of Directive 83/189/EEC.
   The representative of the Commission shall submit to the
   Committee a draft of the measures to be taken. The Committee
   shall deliver its opinion on the draft within a time limit
   which the chairman may lay down according to the urgency of
   the matter, if necessary by taking a vote.
   The opinion shall be recorded in the minutes; in addition,
   each Member State shall have the right to ask to have its
   position recorded in the minutes.
   The Commission shall take the utmost account of the opinion
   delivered by the Committee. It shall inform the Committee of
   the manner in which its opinion has been taken into account.
                           Article 7
                  Committee on Medical Devices
   The Commission shall be assisted by the Committee set up by
   Article 6(2) of Directive 90/385/EEC.
                                                                Ziv
 ---pagebreak---                             -17-
The representative of the Commission shall submit to the
Committee a draft of the measures to be taken. The Committee
shall deliver its opinion on the draft within a time limit
which the chairman may lay down according to the urgency of
the matter. The opinion shall be delivered by the majority
laid down in Article 148(2) of the Treaty in the case of
decisions which the Council is required to adopt on a
proposal    from    the   Commission.   The   votes    of   the
representatives of the Member States within the Committee
shall be weighted in the manner set out in that- Article. The
chairman shall not vote.
The Commission shall adopt the measures envisaged if they are
in accordance with the opinion of the Committee.
If the measures envisaged are not in accordance with the
opinion of the Committee, or if no opinion is delivered, the
Commission shall, without delay, submit to the Council a
proposal relating to the measures to be taken.      The Council
shall act by a qualified majority.
If, on the expiry of a period of three months from the date of
referai to the Council, the Council has not acted, the
proposed measures shall be adopted by the Commission
The Committee referred to in paragraph 1 may examine any
'question connected with the implementation of this Directive.
 ---pagebreak---                                        -18-
                                    Article 8
                               Safeguard clause
   Where a Member State ascertains that the devices                 referred   to
   in  Article     4 ( 1 ) , when    correctly    installed,    maintained    and
   used   for   their      intended    purpose   may   compromise    the  health
   and/or safety of patients, users or, where                applicable,    other
   persons,     and    the    safety    of   property,    it   shall   take   all
   appropriate     interim      measures    to  withdraw    such   devices   from
   the market or prohibit or restrict their being placed on the
   market     or    put      into    service.     The   Member     State    shall
   immediately      inform      the   Commission     of  any    such   measures,
   indicating     the    reasons    for  its   decision   and,   in  particular,
   whether non-compliance with this Directive is due to:
   (a)   failure     to meet     the   essential    requirements    referred   to
         in Article 3;
   (b)   incorrect       application     of  the   standards    referred   to  in
        Article 5, in so far as it is claimed that the                 standards
        have been applied;
   (c)  shortcomings in the standards themselves.
2. The Commission shall enter into consultation with the parties
   concerned      as      soon    as    possible.        Where,     after    such
   consultation, the Commission finds that:
 ---pagebreak---                                 -19-
      the measures are justified, it shall immediately so inform
      the Member State which took the initiative and the other
      Member   States; where the decision referred         to in
      paragraph 1 is attributed to shortcomings in the standards,
      the Commission shall, after consulting the parties
      concerned, bring the matter before the committee referred
      to in "Article '6 (1) within two months if the Member State
      which has taken the decision intends to maintain it and
      shall initiate the procedures referred to in Article 6;
      the measures are unjustified, it shall immediately so
      inform the Member State which took the initiative and the
      manufacturer or his authorized representative established
      within the Community.
3. Where a non-complying device bears the CE marking, the
   competent Member State shall take appropriate action against
   whomsoever has affixed the marking and shall inform the
   Commission and the-other Member States thereof.
4. The Commission shall ensure that the Member States are kept
   informed of the progress and outcome of this procedure.
                             Article 9
                Conformity assessment procedures
1. For all devices other than those covered by Annex 2 and
   devices for performance evaluation, the manufacturer shall,
   in order to affix the CE marking, follow the procedure
   referred to in Annex 3 and draw up the EC declaration of
   conformity required before placing the' devices on the market.
 ---pagebreak---                               -20-
   For all devices for self-testing the manufacturer shall,
   prior to the drawing up of the .aforementioned declaration of
   conformity, fulfil the supplementary requirements set out in
   Annex 3 point 6. Instead of applying this procedure, the
   manufacturer may also follow the procedure referred to in
   paragraph 2.
2. For all devices covered by Annex 2 other than those intended
   for performance evaluation, the manufacturer shall, in order
   to affix the CE-marking either :
    ;a) follow the procedure relating" to the EC declaration of
        conformity set out in Annex 4 (full quality assurance)
        or
    ;b) follow the procedure relating to EC type examination set
        out in Annex 5 coupled with :
        (i)  the procedure relating to EC verification    set out
             in Annex 6, or
        (ii) the  procedure  relating  to the  EC  declaration  of
             conformity  set out in Annex  7  (production  quality
             assurance)
   In the case of devices for performance evaluation, the
   manufacturer shall follow the procedure referred to in Annex
   8 and draw up the statement set out in that Annex before
   placing such devices on the market.
 ---pagebreak---                                -21-
   During the conformity assessment procedure for a device, the
   manufacturer and, if involved, the notified body shall take
   account of the results of any assessment and' verification
   operations which, where appropriate, have been carried out in
   accordance with this Directive at an intermediate stage of
   manufacture.
5. The manufacturer may instruct his authorized representative
   established in the Community to initiate the procedures
   provided for in Annexes 3, 5, 6 and 8.
6. The manufacturer must keep the declaration of conformity, the
   technical documentation referred to in Annexes 3 to 8, as
   well as the decisions, reports and certificates established
   by-notified bodies, and make it available to the national
   authorities for inspection purposes for a period ending five
   years after the last product has. been manufactured.    Where
   the manufacturer is not established in the Community, the
   obligation to make the aforementioned documentation available
   on   request   applies   to    his authorized  representative
   established within the Community.
7. Where the conformity assessment procedure involves        the
   intervention of a notified body, the manufacturer, or     his
   authorized representative established in the Community,   may
   apply to a body of his choice within the framework of     the
   tasks for which the body has been notified.
 ---pagebreak---                                -22-
8.  The notified body may require, where duly justified, any
    information or data, which is necessary for establishing and
    maintaining the attestation of conformity in view of the
    chosen procedure.
9.  Decisions taken by the notified bodies in accordance with
    Annexes 3, 4 and 5 shall be valid for a maximum of five years
    and may be extended on application, made at a t.ime agreed in
    the contract signed by both parties, for further periods of
          V
    five years.
10. The records and correspondence relating to the procedures
    referred to in paragraphs 1 to 3 shall be in one of the
    official languages of the European Community and in the case
    of involvement of a notified body in a Community language
    acceptable to the notified body.
11. By derogation from paragraphs 1 to 3, the competent
    authorities may authorize, "on duly justified request, the
    placing on the market and putting into service, within the
    territory of the Member State concerned, of individual
    devices for which the procedures referred to in paragraphs 1
    to 3 have not been carried out and the use of which is in the
    interest of protection of health.
 ---pagebreak---                                     - 23 -
                                Article 10
                   Registration of manufacturers
   Any manufacturer, who        places devices on the market under his
   own  name,   shall    notify     the    competent    authorities     of   the
   Member State in which he has his registered place of business
   of  the  address     of   the   registered      place  of   business,     the
   categories    of    devices     as    defined     in   terms     of   common
   characteristics     of    technology     and/or    analytes • and    of   any
   significant change thereto. The before mentioned               notification
   shall also   include    any new device       as referred    to   in Article
   11(4).
2. Where a manufacturer, who places devices 'on the market under
   his own name, does not have a registered place of business in
   a   Member     State,      he     shall     designate      an     authorized
   representative    established      in   the   Community.   The    authorized
   representative    shall    inform the competent       authorities     of  the
   Member  State,     in    which    he   has-   his   registered     place   of
   business, of all particulars as referred to in paragraph 1.
3. The Member   States     shall   on   request    inform  the   other   Member
   States  and   the    Commission      of   the   details   referred     to  in
   paragraphs   1 and    2. The procedures        implementing     the  present
   Article    shall   be   adopted    in   accordance    with   the   procedure
   referred to in Article 7 ( 2 ) .
 ---pagebreak---                                      -24-
                                Article 11
                                 Vigilance
   Member States shall take the necessary             steps to ensure      that
   any  information      brought    to   their   knowledge,    in   accordance
   with    the    provisions      of    this   Directive,     regarding     the
   incidents     mentioned     below     involving    devices     bearing    CE
   marking is recorded and evaluated centrally :
   (a)   any    malfunction,       failure    or   deterioration       in   the
         characteristics      and/or performance     of a device,      as well
         as   any inadequacy      in the labelling     or the     instructions
         for use which, directly or indirectly, might              lead to or
         might 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   in   relation     to  the
         characteristics       or   performance    of   a   device    for   the
         reasons     referred    to   in   subparagraph    (a) ,   leading    to
         systematic     recall    of devices    of  the   same   type   by the
         manufacturer.
2. Where    a  Member    State    requires    medical   practitioners,      the
   medical    institutions     or   the organizers     of  external     quality
   assessment schemes to inform the competent authorities of any
   incidents     referred    to   in   paragraph   1,   it   shall   take   the
   necessary steps to ensure that the manufacturer of the device
   concerned,     or  his   authorized     representative     established    in
   the Community, is also informed of the incident.
 ---pagebreak---                                     -25-
3. After  carrying   out   an assessment,      if possible     together     with
   the manufacturer/     Member    States   shall, without      prejudice     to
   Article   8,  immediately    inform    the   Commission    and   the   other
   Member States of the incidents referred to in paragraph 1 for
   which relevant measures have been taken or are contemplated.
4. Where, in the context of notification referred to in Article
   1.0, a  device   notified,     bearing    a   CE   marking,   is   a   "new"
   product,   the  manufacturer 'shall       indicate    this   fact    on   his
   notification. The competent authority           so notified may       at  any
   time within the following two years and on justified grounds,
   require   the manufacturer      to submit    a report    relating    to   the
   experience with the device subsequent            to its being placed       on
   the market. For this purpose, a device is "new" if :
    (a)  such   a  device,     for    the   relevant     analyte    or    other
         parameter, has     not   been   continuously     available     on   the
         Community market during the previous three years,
    (b)  the procedure involves analytical technology not used in
         connection, with    a  given    analyte    or  other   parameter     on
         the  Community    market     continuously     during   the   previous
         three years.
5. The Member    States   shall   on   request    inform   the  other    Member
   States of the details referred to in paragraphs 1 and 4.                  The
   procedures   implementing     the present Article       shall be     adopted
   in accordance with the procedure referred to in Article 7 ( 2 ) .
 ---pagebreak---                                      -26-
                                Article. 12
            Modification of Annex 2, derogation clause
1. Where a Member State considers that :
   (a)   the   list  of   devices       covered   by  Annex    2  should    be
        modified or extended, or
   (b)   the  conformity     of   a   device   or  a  category   of   devices
         should   be  established       by  way   of  derogation    from   the
         provisions   of   Article      9,  by   applying   one  or   several
         alternative    given    procedures     taken  from   amongst    those
         referred to in Article 9,
   it   shall    submit    a    duly     substantiated    request    to-   the
   Commission    and ask    it   to   take   the  necessary   measures.    The
   measures shall be adopted in accordance with Article 7 ( 2 ) .
2. When a measure is to be taken in accordance with paragraph 1,
   due consideration shall be given :
   (a)   to any relevant information available from the vigilance
         procedures   and   from external      quality  assessment    schemes
         as referred to in Article 11
   (b)   to the following criteria
         (i)   whether total reliance has to be put on the             result
               obtained   with      a   given   device,   having   a   direct
               impact on the subsequent medical action, and
 ---pagebreak---                                     - 27 -
          ii) whether     an    action     taken    on   the   basis    of   an
               incorrect     result    obtained     using   a   given    device
               could prove to be hazardous to the patient or third
               party   as a consequence       of  false positive     or   false
               negative results, and
         ;iii) whether     the   involvement     of    a  notified     body   is
               appropriate and justified.
3. The Commission shall inform the Member States of. the measures
   taken   and,  where   appropriate, publish        these measures     in  the
   Official Journal of the European Communities.
                                Article 13
                             Notified bodies
   Member   States   shall    notify   the   Commission    and   other   Member
   States of the bodies which they have designated               for  carrying
   out  the   tasks   pertaining     to   the  procedures     referred   to  in
   Article   9 and   the   specific    tasks   for which     the bodies    have
   been  designated.     The   Commission     shall   assign   identification
   numbers to these bodies, hereinafter referred to as               "notified
   bodies".
 ---pagebreak---                               -28-
   The Commission shall publish a list of the notified bodies,
   together with the identification numbers it has allocated to
   them and the tasks for which they have been notified, in the
   Official Journal of the European Communities. It shall ensure
   that the list is kept up to date.
2. Member States shall apply the criteria set out in Annex 9 for
   the designation of bodies. Bodies that meet the criteria laid
   down in the national standards which transpose the relevant
   harmonised standards shall be presumed to meet the relevant
   criteria.
   A Member State that has notified a body shall withdraw that
   notification if it finds that the body no longer meets the
   criteria referred to in paragraph 2. It shall immediately
   inform the other Member States and the Commission of any
   withdrawal of notification for the aforementioned or any
   other reason.
   The notified body and the manufacturer, or its authorized
   representative established in the Community, shall lay down,
   by common accord, the time limits for completion of the
   assessment and verification operations referred to in Annexes
   3 to 7.
5. The notified body must make available to the other notified
   bodies and the competent authority, on request, all relevant
   information concerning approvals and certificates issued,
   refused or withdrawn.
 ---pagebreak---                               -29-
                           Article 14
                           CE-marking
1. Devices, other than devices for performance evaluation,
   considered to meet the essential requirements referred to in
   Article 3 must bear the CE marking of conformity when they
   are placed on the market.
2: The CE-marking of ^conformity, as shown in Annex 10, must
   appear in a visible, legible and indelible form on the
   device, where practicable and appropriate, and on the
   instructions, for use. Where applicable the CE "marking of
   conformity must also appear on the sales packaging. The CE
   marking shall be accompanied by the identification number of
   the notified body responsible for implementation of the
   procedures set out in Annexes 4, 6 and 7.
   It is prohibited to affix marks or inscriptions which are
   likely to mislead "third parties with regard to the meaning or
   the graphics of the CE marking. Any other mark may be affixed
   to the device, to the packaging or to the instruction leaflet
   accompanying the device provided that the visibility and
   legibility of the CE marking is not thereby reduce.
                                                                  u^r '-
 ---pagebreak---                                     -30-
                                Article 15
                       Unduly affixed CE marking
Without prejudice to Article 8 :
  a) where a Member State establishes that the CE marking has been
     affixed     unduly,    the    manufacturer      or   his     authorized
     representative    established     within   the   Community    shall   be
     obliged   to  end  the  infringement   under   conditions   imposed   by
     the Member State
 (b) where   non-compliance    continues,   the   Member  State   must   take
     all appropriate measures      to restrict or prohibit      the  placing
     on the market of the product in question or to ensure that it
     is   withdrawn    from   the   market,    in   accordance    with    the
     procedure in Article 8.
                                Article 16
            Decisions in respect of refusal or restriction
1.   Any decision taken pursuant to this Directive :
      (a)  to refuse or restrict      the placing    on the market    or  the
           putting into service of a device or
      (b)  to withdraw devices from the market
 ---pagebreak---                                 -31-
     shall state the exact grounds on which it is based. Such
     decisions shall be notified without delay to the party
     concerned, who shall at the same time be informed of the
     remedies available to him under the national law in force in
     the Member State in question and of the time limits to which
     such remedies are subject.
2.   In the event of a decision as referred to in paragraph 1, the
     manufacturer, or his authorized representative established in
     the Community, shall have an opportunity to put forward his
     viewpoint in advance, unless such consultation is not
     possible because of the urgency of the measure to be taken.
                            Article 17
                          Confidentiality
Without prejudice . to the existing national provisions and
practices on medical secrets, Member States shall ensure that all
the parties involved in the application of this Directive are
bound to observe confidentiality with regard to information
obtained in carrying out their tasks. This does not affect the
obligations of Member States and notified bodies with regard to
mutual information and the dissemination of warnings, nor the
obligations of the persons concerned to provide information under
criminal law.
                                                                  J.°V
 ---pagebreak---                                  -32-
                              Article 18
                  Cooperation between Member States
Member States shall take appropriate measures to ensure that
competent authorities charged with the implementation of the
present Directive cooperate with each other and convey to each
other the information necessary to ensure compliance with the
provisions of this Directive.
                              Article 19
                       Amendment of--Directives
     Directive 93/42/EEC is hereby amended as follows :
     a)    Article 1(2) c) shall read as follows :
     " (c) in vitro diagnostic medical device means any medical
     device which is a reagent, reagent product, calibrator,
     control material, kit, instrument, apparatus, equipment or
     system whether used alone or in combination, intended by the
     manufacturer to be used in vitro for the examination of
     specimens including blood and tissue donations, derived from
     the human body, solely or principally for the purpose of
     providing information concerning a physiological state, state
     of health or disease or congenital abnormality or to determine
     the safety and compatibility with potential recipients".
                                                                    Cf)
 ---pagebreak---                          -33-
b) Article l(5)f shall read as follows :
   "(f) transplants or tissues or cells of human origin,
   unless a device is manufactured utilizing tissues or
   substances derived from such tissues which are non viable
   or rendered non viable. In this case, the directive shall
   not affect national regulations relating to the ethics of
   the collection of tissues or substances of human origin,
   as well as any regulations relating to the ethics
   governing distribution of given types of devices of such
   origin."
c) Annex I, paragraph 8.2, shall read as follows :
   "8.2.Where a device is manufactured utilizing human
   tissues or substances derived from human tissues, the use
   of such tissues or substances must be subject to the
   relevant validated selection and screening procedures,
   including traceability as appropriate in relation to the
   inherent risk.
   Tissues of animal origin must originate from animals that
   have   been   subjected    to  veterinary  controls   and
   surveillance adapted to the intended use of the tissues.
   Processing,   preservation,   testing .and   handling   of
   tissues, cells and substances of human or animal origin
   must be carried out so as to provide optimal security. In
   particular safety with regard to viruses and other
   transmissible agents must be addressed as appropriate by
   implementation of validated' methods of elimination or
   inactivation of such viruses or other transmissible
   agents in the course of the manufacturing process, taking
   into account the sourcing and control methods applied."
 ---pagebreak---                                    - 34 -
   d)   Annex     I   paragraph    13.3    shall    be   completed    by   the
        following subparagraph :
        "n)    in   the  case   of   devices    incorporating     tissues   of
        human origin or substances derived            from such tissues, a
        statement indicating that the device incorporates               tissue
        or   substances     derived   from   tissue    of   human  origin   as
        appropriate"
    e)  In annex II paragraph 3.2c) and annex III paragraph 3 the
        following indent shall be included as third last indent :
        "in the case of devices incorporating tissues of human or
        animal origin, information on the selection and origin"
    f)  Annex IX, section III, paragraph 4.5           : the following sub-
        paragraph shall be added :
        "All    devices    manufactured     utilizing     human   tissues   or
        substances derived from such tissues are in class III."
2. In  Directive     89/392/EEC,    the   text   of  Article    1(3),   second
   indent   " machinery     for medical     use,   used   in  direct   contact
   with patients" is replaced by the following text :
                          "- medical devices"
                                                                               4C°>
 ---pagebreak---                                  - 35 -
                             Article 20
           Implementation, transitional provisions
Member   States   shall   adopt   and publish     the   laws,    regulations
and  administrative     provisions     necessary    to   comply   with    this
Directive- not later than 1 April 1998. They shall               immediately
inform the Commission thereof.
The Standing Committee referred to in Article 7 may assume its
tasks   from  the   date   of  notification     of  this    Directive.     The
Member States may take the measures referred to in Article 13
on notification of this Directive.
When Member States adopt these provisions, these shall contain
a reference to this 1 Directive or shall be accompanied by such
a  reference   at   the  time   of   their   official    publication.      The
procedures    for   such    reference    shall   be   adopted     by   Member
States.
Member   States   shall   apply   these provisions       with   effect    from
1 July 1998.
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.
                                                                               52>
 ---pagebreak---                                  36
     Member States shall take the necessary action to ensure that
     the notified bodies which are responsible pursuant to Article
     9 for conformity assessment take account of any relevant
     information regarding the characteristics and performance of
     such devices, including in particular the results of any
     relevant tests and verification already carried out under
     pre-existing national law, regulations or administrative
     provisions in respect of such devices.
     Member States shall accept during a period of four years
     following adoption of the present Directive the placing on
     the market and putting into service of devices which conform
     to the rules in force in their territory on the date of
     adoption of this Directive.
                             Article 21
This Directive, shall enter into force the twentieth day after its
publication.
                             Article 22
This Directive is addressed to the Member States.
 ---pagebreak---                                -37-
                                                Annex 1
                     ESSENTIAL REQUIREMENTS
I. GENERAL REQUIREMENTS
   The devices must be designed and manufactured in such a way
   that, when used under the conditions and for . the purposes
   intended, they will not compromise, directly or indirectly,
   the clinical condition or the safety of the patients, e-r- the
   safety and health of users and, where applicable, other
   persons, and the safety of property. Any risks, which may be
   associated with their use, must be acceptable when weighed
   against the benefits to the patient and are compatible with a
   high level of protection of health and safety.
   The solutions adopted by the manufacturer for the design and
   construction   of   the • devices must    conform    to  safety
   principles, taking account of the generally acknowledged
   state of the art.
   In selecting the most appropriate solutions, the manufacturer
   must apply the following principles in the following order :
        eliminate or reduce risks as far as possible (inherently
        safe design and construction)*
        where appropriate take adequate protection measures in
        relation to risks that cannot be eliminated»
                                                    J
        inform users of the residual risks            due  to  any
        shortcomings of the protection measures.
 ---pagebreak---                            -38-
The devices must be designed and manufactured in such ~a~ way
that they are suitable for the purposes referred to in
Article l(2)(b), as specified by the manufacturer, taking
account of the generally acknowledged state of the art. They
must achieve the performances in particular in terms of
analytical sensitivity, specificity, accuracy, repeatability,
reproducibility and limits of detection stated by the
manufacturer.
The traceability of values assigned to calibrators and/or
controls materials must be assured through available reference
measurement procedures and/or available reference materials
of higher order.
The characteristics and performances referred to in Sections
1 and 3 must not be adversely affected to such a degree that
the health-',or" the safety of the patient or the user and,
where applicable, of other persons, are compromised during
the lifetime of the device, as indicated by the manufacturer,
when the device is subject to the stresses which can occur
during normal conditions of use. When no lifetime is stated,
the same applies for the 'lifetime reasonably to be expected
of a device of that kind, having regard to the intended
purpose and the anticipated use of the device.
The devices must be designed, manufactured and packed in such
a way that their characteristics and performances during
their intended use will not be adversely affected in the
storage and transport conditions (temperature, humidity, ...)
taking account of the instruction and information provided by
the manufacturer.
 ---pagebreak---                                -39-
II. REQUIREMENTS REGARDING DESIGN AND MANUFACTURING
6.  Chemical and physical properties
    6.1. The devices must be designed and manufactured in such a
         way as to achieve the characteristics and performances
         referred to in Section I on the "General Requirements".
         Attention must be paid to the possibility of impairment
         of analytical performance due to incompatibilityvbetween
         the materials used and the samples (such . as biological
         tissues,   cells, body     fluids  and   micro-organisms)
         intended to be used with the device, taking account of
         its intended purpose.
    6.2. The devices must be designed, manufactured and packed in
         such a way as to reduce as far as possible the risk
         posed by leakage products, contaminants and residues to
         the persons involved in the transport, storage and use
         of the devices, taking account of the intended purpose
         of the products.
7.  Infection and microbial contamination
    7.1. The devices must be designed in such a way as to
         eliminate or reduce as far as possible the risk of
         infection to the user or other persons. The design must
         allow easy handling and, where necessary, reduce as far
         as possible contamination of and leakage from the device
         during use and, in the case of specimen receptacles, the
         risk of contamination of the specimen. The manufacturing
         processes must be appropriate for these purposes.
 ---pagebreak---                              -40-
7.2. Where a device incorporates biological substances," "the
      risks of infection must be reduced as far as possible by
      selecting appropriate donors, appropriate substances and
      using appropriate ihactivation, conservation, test and
      control procedures.
7.3. Devices labelled either as "STERILE", or, as h&Ying &
      special   microbiological      state   must   be   designed,
      manufactured and packed         in an appropriate pack,
      according to procedures suitable to ensure that they
      remain in the microbiological state indicated on the
      label when placed on the market, under the storage and
      transport conditions as laid down by the manufacturer,
      until the protective packaging is damaged or opened.
7.4. Devices labelled either as "STERILE", or, as having a
      special microbiological state must have been' processed
      by an appropriate, validated method.
7.5. Packaging systems for devices other than those referred
      to in section 7.3 must keep the product without
      deterioration at the level of cleanliness, if any, as
      indicated by the manufacturer and, if the devices are to
      be sterilized prior to use, reduce as far as possible
      the risk of microbial contamination.
    • Steps shall be taken to reduce microbial contamination
      during   selection   and handling       of  raw materials,
      manufacture,    storage     and   distribution   where   the
      performance of the device can be adversely affected by
      such contamination.
                                                                  <y
 ---pagebreak---                                -41-
8. Construction and environmental properties
   8.1. If the device is intended for use in combination with
        other devices or equipment, the whole combination,
        including the connection system must be safe and must
        not impair the specified performances of the devices.
        Any restrictions on use must be indicated on the label
        and/or in the instructions for use.
   8.2  Devices must be designed and manufactured in such a way
        as to remove or reduce as far as possible :
             the risk of injury, in connection with their
             physical     features,      including    aspects    of
             volume x pressure, dimensional" and where appropriate
             ergonomie features;
             risks    connected     with   reasonably   foreseeable
             external influences, such as magnetic fields,
             external     electrical      effects,    electrostatic
             discharge, pressure, temperature or variations in
             pressure or acceleration.
        Devices must be designed and manufactured in such a way
        as to provide an adequate level of intrinsic immunity
        from electromagnetic disturbance to enable them to
        operate in accordance with their intended purpose.
                                                                    ^
 ---pagebreak---                              -42-
     Devices must be designed, and manufactured in such a way
     as to reduce as far as possible the risks of fire or
     explosion during normal use. Particular attention must
                         •L
     be paid to devices whose intended use includes exposure
     to or use in association with flammable substances or
     substances which could cause combustion.
  4. Devices must be designed and manufactured in such a way
     as to facilitate the management of safe waste disposal.
  5  The measuring, monitoring or display scale (including
     colour change and other visual indicators) must be
     designed and manufactured in line with ergonomie
     principles, taking account of the intended purpose of
     the device.
Devices which are instruments or apparatus with a measuring
function
9.1. Devices which are instruments or apparatus having a
     primary analytical measuring function must be designed
     and manufactured in such a way as to provide adequate
     stability and accuracy of measurement within appropriate
     accuracy limits, taking, into account the intended
     purpose of the device and of available and appropriate
     reference measurement procedures and materials. The
     accuracy    limits    have   to be   specified   by   the
     manufacturer.
                                                               CC
 ---pagebreak---                                                -43-
    9.2. When values are expressed numerically, they must be
           given in legal units conforming to the provisions of
           Council Directive 80/181/EEC n
10. Protection against radiation
    10.1 Devices shall be designed and manufactured in such a way
           that exposure of users and other persons to the emitted
           radiation is reduced as far as possible-.
    10.2 When devices are intended to emit potentially hazardous,
           visible and/or invisible radiation, they must be :
           - designed and manufactured in such a way as to ensure
              that the quality and quantity of radiation emitted can
              be adjusted and controlled;
           - fitted, where practicable, with visual displays and/or
              audible warnings of such emissions.
    10.3 The         operating          instructions            for       devices       emitting
            radiation must give detailed information as to the
           nature of the emitted radiation, means of protecting the
           user, and on ways of avoiding misuse and of eliminating
            the risks inherent in installation.
    OJ Nr. L 39. 15.02.1980, p. 40, directive as last amended by Directive 89/617/EEC, OJ Nr. L 357,
    07.12.1989. P. 28.
                                                                                                     (a\
 ---pagebreak---                                                -44-
11.   Requirements for medical devices connected                         to or equipped
      with an energy source
       11.1 Devices incorporating electronic programmable systems
             must be designed to ensure the repeatability, reliability
             and performance of these systems according to the
             intended use.
       11.2 Devices must be designed and manufactured in such a way
             as to minimize the risks of creating electromagnetic
             fields which could impair the operation of other devices
             or equipment in the usual environment.
       11.3 Devices must be designed and manufactured in such a way
             as to. avoid, as far as possible, the risk of accidental
             electric shocks during normal use and in single fault
             condition, provided the devices are installed and
             maintained correctly.
       11.4 Protection against mechanical and thermal risks
       11.4.1 Devices must be designed and manufactured in such a way
                 as to protect the user against mechanical risks
                 connected with, for example, resistance, stability and
                 moving parts.               Annex 1, sections 1.3 and 1.4 of
                 Directive 89/392/EEC 12 shall apply, were appropriate.
12
    Council Directive 89/392/EEC, OJ Nr. L 183, 29.6.1989, as last amended by Council Directive
    93/68/EEC, OJ Nr. L 220, 30.8.1993, p. I
 ---pagebreak---                                 - 45 -
11.4.2 Devices must be designed and manufactured in such a way
       as  to  reduce    to  the   lowest    possible   level    the   risks
       arising from vibration generated by the devices, taking
       account    of   technical       progress    and    of    the    means
       available    for    limiting     vibrations,     particularly      at
       source, unless, the vibrations are part of the specified
       performance.
11.4.3 Devices must be designed and manufactured in such a way
       as  to  reduce    to  the   lowest    possible   level    the   risks
       arising   from    the   noise     emitted,   taking     account    of
       technical progress and of the means available to reduce
       noise, particularly at source, unless the noise emitted
       is part of the specified performance.
11.4.4 Terminals     and    connectors      to   electricity,       gas   or
       hydraulic and pneumatic energy supplies which the user
       has to handle must be designed and manufactured in such
       a way .as .to minimize all possible risks.
11.4.5 Accessible parts of the devices          (excluding the parts or
       areas    intended      to    supply     heat    or    reach     given
       temperatures)     and   their    surroundings    must   not    attain
       potentially dangerous temperatures under normal use.
 ---pagebreak---                                       - 46 -
12. Requirements for devices for self-testing
    Devices for self-testing must be designed and manufactured                    in
    such a way that they perform appropriately for their                   intended
    purpose    taking    into    account      the    skills      and    the    means
    available to users and the influence resulting from variation
    that   can  reasonably    be   anticipated      in  users'      technique    and
    environment. The information and instructions provided by the
    manufacturer    should be    easily understood         and    applied    by  the
    user.
    12.1 Devices      for    self-testing         must     be      designed      and
          manufactured    in   such     a   way   as   to   reduce     as   far   as
          practicable   the risk of user's error           in handling and        in
          interpretation of the result.
    12.2 Devices      for    self-testing         must,      where      reasonably
          possible,    include    a    method    of   user     control,     i.e.   a
          procedure by which the user can reasonably verify                    that,
          at   the   time   of    use,     the   product      will    perform     as
          intended.
13. Information supplied by the manufacturer
    13.1 Each    device   must     be    accompanied      by    the    information
          needed   to   use . it    properly,       taking     account      of   the
          training   and   knowledge      of   the   potential      users    and  to
          identify the manufacturer.
 ---pagebreak---                            -47-
     This information comprises the data on the label and in
     the instructions for use.
     As far as practicable and appropriate, the information
     needed to use the,device properly must be set out on the
     device itself and/or on the packaging or, where
     appropriate, on the sales packaging. If individual full
     labelling of each unit is not practicable, the
     information must be set out on the packaging and/or in
     the instructions for use supplied with one or more
     devices.
     Instructions for use must accompany or be included in the
     packaging of one or more devices.
     By way of exception, no such instructions for use are
     needed for a device if it can be used properly and safely
     without them.
13.2 Where appropriate, this information to be supplied
     should take the form of symbols. Any symbol and
     identification   colour    used  must   conform  to   the
     harmonized standards. In areas for which no standards
     exist, the symbols and colours as used must be described
     in the documentation supplied with the device.
                                                              L<
 ---pagebreak---                            -48-
13.3 In the case of devices containing a substance or being a
     preparation which may be considered as being dangerous,
     taking account of the nature and quantity of its
     constituents and the form under which they are present,
     relevant danger symbols and labelling requirements of
     Directive 67/548/EEC and Directive 88/379/EEC shall
     apply. Where there is insufficient space to put all
     information on the device itself or on its label, the
     relevant danger symbols shall be put on the label and
     the other information required by those Directives shall
     be given in the instructions for use.
     The provisions of the aforementioned directives on the
     safety data sheet shall apply, unless all relevant
     information as appropriante is already made available by
     the instructions for use.
13.4 The label must bear the following particulars which may
     take the form of symbols as appropriate:
     a) the name or trade name         and   address  of the
        manufacturer. For devices imported into the Community,
        in view of their distribution in the Community, the
        label, or the outer packaging, or instructions for
        use, shall contain in addition the name and address of
        the authorized representative of the manufacturer
        established within the Community;
                                                               G?C?
 ---pagebreak---                              -49-
     b) the details strictly necessary for the user to
         identify the device and the contents of the packaging.
     c) where appropriate, the word "STERILE" or a statement
         indicating any special microbiological state or state
         of cleanliness;
     d) where   appropriate, the batch     code, preceded by  the
         word "LOT", or the serial number; .
     e) where appropriate, an indication of the date by which
         the device or part of it should be used,, expressed as
         the year, the month and, where relevant, the day;
     f) in cases of devices for performance evaluation, the
         words "for performance evaluation only";
     g) where appropriate, a statement indicating the in vitro
         nature of the device;
     h) any special storage and/or handling conditions;
     i) where applicable any special operating instructions;
     j) appropriate warnings and/or precautions to take;
     k) if the device is intended for self-testing, this fact
         should be clearly stated.
     1) In the case of "devices    incorporating tissues of human
         origin or substances     derived from such tissues, a
         statement indicating     that the device incorporates
         tissues or substances     derived from tissue of human
         origin.
13.5 If the intended purpose of the device is not obvious to
     the user, the manufacturer must clearly state the
      intended purpose in the instructions for use and, if
      appropriate,- on the label.
 ---pagebreak---                               -SO-
IS. 6 Wherever   reasonable    and  practicable,   the   devices  and
      detachable    components     must   be    identified,     where
      appropriate    in    terms   of   batches,    to    allow   all
      appropriate action to detect any potential risk posed by
      the devices and detachable components.
13.7 Where appropriate, the instructions for use must contain
      the following particulars :
      a) the details referred to in           Section. 13.4,     with
         exception of points d) and e) ;
     b) composition of the reagent product by nature and
         amount or concentration of the active ingredient(s) of
         the reagent(s) or kit tas well as a statement that the
         device contains other ingredients influencing the
         measurement;
      c) the storage conditions and shelf life following the
         first opening of the immediate container, together
         with the storage conditions and stability of working
         reagents;
     d) the performances referred to in Section 3;
      e) a   statement    of   any   special   materials     required
         including    information    necessary   to    enable   those
         special materials to be identified for proper use;
      f) the type of specimen to be used,               any   special
         conditions    of   collection,   pre-treatment     and,   if
         necessary, storage conditions;
      g) a detailed description of the procedure to be followed
         in using the device;
                                                                      / s/
 ---pagebreak---                   D
                        -51-
h) the measurement procedure to be        followed with the
   device including as appropriate :
   - the principle of the method;
   - the specific analytical performance characteristics
     '(e.g.     analytical     sensitivity,      specificity,
     accuracy, repeatability, reproducibility and limits
     of detection), limitations of the method and
     information about the use of available reference
     measurement procedures and materials by the user;
   - the details of any further procedure or handling
     needed before the device can be used (for example
     reconstitution, incubation, dilution, instrument
     checks, etc);
   - the indication whether any particular training is
     required;
i) the mathematical approach upon which the calculation
   of the analytical result is made;
j) measures to be taken in the event of changes in the
   analytical performance of the device;
k) information appropriate to users on :
        internal    quality   control   including    specific
       validation procedures,
   - the traceability of the calibration of the device;
1) the reference     intervals   for  the  quantities   being
   determined;
 ---pagebreak---                        -52-
m) if the device must be used in combination with or
   installed with or connected to other medical devices
   or equipment in order to operate as required for its
   intended    purpose,     sufficient    details   of  its
   characteristics to identify the correct devices or
   equipment to use in order to obtain a safe and proper
   combination;
n) all the information needed to verify whether the
   device is properly installed and can operate correctly
   and safely, plus details of the nature and frequency
   of the maintenance and calibration needed to ensure
   that the device operates properly and safely;
   information about safe waste disposal;
o) the necessary instructions in the event of damage to
   the sterile protective packaging and details of
   appropriate     methods      of     resterilization   or
   decontamination;
p) if the device is reusable, information on the
   appropriate processes to allow reuse, including
   cleaning, disinfection, packaging and resterilization
   or decontamination, and any restriction on the number
   of reuses;
q) precautions to be taken as regards exposure, in
   reasonably foreseeable environmental conditions, to
   magnetic fields, external influences, electrostatic
   discharge, pressure       or variations     in pressure,
   acceleration, thermal ignition sources, etc.;
 ---pagebreak---                          -53-
 r) precautions to be taker! against any special, unusual
    risks related to the use or disposal of the device
    including special protective measures;- where the
    device includes substances of human or animal origin,
    attention shall be drawn to their potential infectious
    nature;
s)  specifications for devices for self-testing :
    - the results need to be expressed and presented in a
      way    that    is readily   understood    by   a non-
      professional • person; information needs to be
      provided with advice to the user on action to be
      taken     (in    case   of  positive,    negative    or
      indeterminate result) and on the possibility of
       false positive or false negative result;
    - specific particulars may be omitted provided that
      the other information supplied by the manufacturer
       is sufficient to enable the user to know how to use
      the device and to understand the result(s) produced
      by the device;
    - the information provided must include a statement
       clearly directing that the user should not take any
      decision     of medical    relevance   without    first
       consulting his or her medical practitioner;
 t) date of issue or last revision of the instructions for
    use.
                                                              ^v
 ---pagebreak---                                54-
                                                     Annex 2
          LIST OF DEVICES REFERRED TO IN ARTICLE 9(2)
1. Reagents and reagent products     for blood  grouping   ( A B O
   system and Rho/D)
2. Reagents and reagent products for the detection in human
   specimens of markers of HIV infection, Hepatitis B and C .
                                                                   ^2.
 ---pagebreak---                                55-
                                                     Annex 3
                 EC DECLARATION OF CONFORMITY
   The EC declaration of conformity is the procedure whereby the
   manufacturer or his authorized representative established in
   the Community who fulfils the obligations imposed by Sections
   2 to 5 and additionally, 4in the case of devices for self-
   testing, the obligations imposed by Section 6, ensures and
   declares that the products concerned meet the provisions of
   this Directive which apply to them. The manufacturer must
   affix the CE marking in accordance with Article 14.
2. The manufacturer must prepare the technical documentation
   described in Section 3 and ensure that the manufacturing
   process follows the principles of quality assurance as set
   out in section 4.
3. The technical documentation must allow assessment of      the
   conformity of the product with the requirements, of       the
   Directive. It must include in particular :
                                                                 -^
 ---pagebreak---                             -56-
- a general description of the product, including any variants
  planned;
- the documentation of the, quality system;
- design information, including performance characteristics
  and limitation, methods of manufacture and, in the case of
  instruments, design drawings, diagrams of components, sub-
  assemblies, circuits, etc.;
- the descriptions and explanations necessary to understand
  the abovementioned characteristics, drawings .and diagrams
  and the operation of the product;
- the results of the risk analysis,   where appropriate, and 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    of the Directive if the
  standards referred to in Article 5   have not been applied in
  full;
- in the case of sterile products or products with a special
  microbiological state or state of cleanliness, a description
  of the procedures used;
- the   result's of  the design     calculations   and  of  the
  inspections carried out, etc...
- if the device is to be combined with other device (s) in
  order to operate as intended, proof must be provided that it
  conforms to the essential requirements when combined with
  any such device(s) having the characteristics specified by
  the manufacturer;
- the test reports,*
 ---pagebreak---                            -57-
- adequate performance evaluation data, supported by a
  reference measurement system (when available), originated
  from studies in a clinical or other appropriate environment
  or resulting from available literature; this applies in
  particular to biological materials, culture media and
  devices using a new technology;
- the labels and instructions for use.
The manufacturer shall take necessary measures to ensure^ that
the manufacturing process follows the principles of quality
assurance as appropriate for the products manufactured.
The system shall address :
   the organizational structure and responsibilities,
   the manufacturing processes and systematic quality control
   of production;
   the means to monitor the performance of the quality system;
                                                               "6
 ---pagebreak---                                -58-
   The manufacturer shall institute and keep up to date a
   systematic procedure to review experience gained from devices
   in the post-production phase and to implement appropriate
   means to apply any necessary corrective actions, taking
   account of the nature and risks in relation to the product.
   He shall notify the' competent authorities of the following
   incidents immediately on learning of them :
   (i)   any malfunction, failure or deterioration in the
         characteristics and/or performance of a device, as well
         as any inadequacy in the labelling or the instructions
         for use which, directly or indirectly, might lead to or
        might have led to the death of a patient or user or to a
         serious deterioration in his state of health;
   (ii) any technical or medical reason connected with the
         characteristics or the performance of a device for the
         reasons referred to in subparagraph (i) above leading to
         systematic recall ,of devices 'of the same type by the
        manufacturer.
6. For devices for self-testing the manufacturer shall lodge an
   application for examination of the design with a notified
   body.
   6.1   The application shall enable the design of the device to
        be understood and shall enable conformity with the
        design-related requirements of the directive to be
         assessed.
                                                                 \ ,
 ---pagebreak---                            -59
     It shall include :
        test reports including, where appropriate, results of
        studies carried out with lay persons;
        data showing the handling suitability of the device in
        view of its intended purpose for self-testing;
        the information to be provided with the devi-ce on its
       'label and its instructions for use.
6.2 The notified body shall examine the application and, if
    the design conforms to the relevant provisions of this
    Directive shall issue the applicant with an EC design-
    examination certificate. The notified body may.require the
    application to be completed by further tests or proof to
    allow assessment of conformity with the design-related
    requirements of the Directive. The certificate shall
    contain the conclusions of the examination, the conditions
    of validity, the data needed7 for identification of the
    approved design and, where appropriate, a description of
    the intended purpose of the product.
6.3 The applicant shall inform the notified body which issued
    the EC designed-examination certificate of any significant
    change made to the approved design. Changes to the
    approved design must receive further approval from the
    notified body which issued the EC design-examination
    certificate wherever the changes could affect conformity
    with the essential requirements of the Directive or with
    the conditions prescribed for use of the product. This
    additional approval shall take the form of a supplement to
    the EC design-examination certificate.
 ---pagebreak---                                60-
                                                     Annex 4
                  EC DECLARATION OF CONFORMITY
                (FULL QUALITY ASSURANCE SYSTEM)
1. The manufacturer must ensure application of the quality
   system approved for the design, manufacture and final
   inspection of the products concerned, as specified in Section
   3, and is subject to audit as laid down in section 3.3 and to
   the EC surveillance as specified in Section 4.
2. The declaration of conformity is the procedure whereby 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 CE marking in accordance
   with Article 14 and shall draw up a declaration of conformity
   covering the products concerned.
3. Quality system
   3.1 The manufacturer must lodge an application for assessment
       of his quality system with a notified body.
                                                                 %
 ---pagebreak---                              61 -
    The application must include:
    - the name and address of the manufacturer and any
      additional manufacturing site covered by the quality
      system;
    - adequate information on the product or product category
      covered by the procedure;
    - a written declaration that no such application has been
    * lodged with any other notified body for the same
      product-related quality system;
    - the documentation on the quality system;
    - an undertaking by the manufacturer to fulfil          the
      obligations imposed by the quality system approved;
    - an undertaking by the manufacturer to keep the approved
      quality system adequate and efficacious;
    - an undertaking by the manufacturer to institute and keep
      up to date a systematic procedure to review experience
      gained * from ,devices in the post production phase and to
      implement appropriate means to apply any necessary
      corrective action and notification as referred to in
      Annex 3, section 5 .
3.2 Application of the quality system must ensure that the
    products conform to the provisions of this Directive which
    apply to them at every stage, from design to final
    inspection. All the elements, requirements and provisions
    adopted by the manufacturer for his quality system must be
    documented in a systematic and orderly manner in the form
    of written policies and procedures, such as quality
    programmes, quality plans, quality manuals and quality
    records.
 ---pagebreak---                         - 62 -
It shall include in particular an adequate description of:
(a) the manufacturer's quality objectives;
(b) the organization of the business and in particular:
    - the organizational structures, the responsibilities
      of the managerial staff and their organizational
      authority where quality of design and manufacture
      of the products is concerned;
    - the methods of monitoring       the efficient   operation
      of the quality system and in particular its ability
      to  achieve  the desired     quality  of  design  and  of
      product,  including control of products which        fail
      to conform;
(c) the procedures for monitoring and verifying the design
    of the products and in particular:
    - a general description of the product, including any
      variants planned;
    - all documentation referred to in Annex        3,  section
      3, indents 3 to 11;
    - in the case of devices for self-testing, the
      information referred to in Annex 3, section 6.1;
    - the techniques used to control and verify the
      design and the processes and systematic measures
      which will be used when the products are being
      designed;
(d) the inspection and quality assurance techniques at the
    manufacturing stage and in particular:
    - the processes   and procedures which will be        used,
      particularly     as      regards    sterilization     and
      purchasing;
                                                              *>
 ---pagebreak---                            -63-
        - the product identification procedures drawn up and
          kept up to date from drawings, specifications or
          other relevant documents       at   every  stage of
          manufacture;
        the appropriate^tests and trials which will be carried
        out before, during and after manufacture, the
        frequency with which they will take place, and the
        test equipment used;     it must be possible to trace
        back the calibration of the test equipment adequately.
3.3  The notified body must audit the quality system to
     determine whether it meets the requirements referred to
     in Section 3.2.    It must presume that quality systems
     which implement the relevant harmonized          standards
     conform to these requirements.
     The assessment team must include at least one member with
     past experience of assessments of the technology
     concerned.    The assessment procedure must include an
     inspection on the manufacturer's premises and, in duly
     substantiated    cases,    on   the    premises   of   the
     manufacturer's suppliers and/or subcontractors to inspect
     the manufacturing processes.
     The decision shall be notified to the manufacturer. It
     must contain the conclusions of the inspection and a
     reasoned assessment.
'3.4 The manufacturer must inform the notified body which
     approved the quality system of any plan for substantial
     changes to the quality system or the product-range
     covered.
 ---pagebreak---                               -64-
        The notified body must assess the changes proposed and
        verify whether after these changes the quality system
        still meets the requirements referred to in Section 3.2.
        It must notify the manufacturer of its decision. This
        decision must contain the conclusions of the inspection
        and a reasoned assessment.
4. Surveillance
   4.1  The aim of surveillance is to ensure that the
        manufacturer duly fulfils the obligations imposed by the
        approved quality system.
                                 t-
   4.2  The 'manufacturer must authorize the notified body to
        carry out all the necessary inspections and supply it
        with all relevant information, in particular:
        - the documentation on the quality system;
        - the data stipulated in the part of the quality system
          relating to design, such as the results of analyses,
          calculation, tests, etc.;
        - the data stipulated in the part of the quality system
          relating to manufacture, such as inspection reports and
          test data, calibration data, qualification reports of
          the personnel concerned, etc.
   4.3 The notified body must periodically carry  out appropriate
       inspections and assessments to make        sure that the
       manufacturer applies the approved quality  system and must
       supply the manufacturer with an assessment report.
                                                                  <X7
 ---pagebreak---                            -65-
4.4 In addition, the notified body may pay unannounced visits
    to the manufacturer.    At the time of such visits, the
    notified body may, where necessary, carry out or ask for
    tests in order to check that the quality system is working
    properly.    It must provide the manufacturer with an
    inspection report 'and, if a test has been carried out,
    with a test report.
 ---pagebreak---                               -66-
                                                Annex 5
                      EC TYPE-EXAMINATION
1. EC type-examination is the part of the procedure whereby a
   notified body ascertains and certifies that a representative
   sample of the production envisaged fulfils the relevant
   provisions of this Directive.
2. The application for EC type-examination shall be lodged by the
   manufacturer or by his authorized representative established
   in the Community with a notified body.
   The application shall include:
      the name and address of the manufacturer and the name and
      address of the authorized representative if the application
      is lodged by the representative;
      the documentation described in Section 3 needed to assess
      the conformity of the representative sample of the
      production in question, hereinafter referred to as the
      "type", with the requirements of this Directive.        The
      applicant shall make a "type" available to the notified
      body.   The notified body may request other samples as
      necessary;
      a written declaration that no application has been lodged
      with any other notified body for the same type.
 ---pagebreak---                                -67-
3. The documentation must allow an understanding of the design,
   the manufacture and the performances of the product.       The
   documentation " shall    contain  the   following   items   in
   particular:
   - a general description of the type, including any variants
     planned;
   - all documentation referred to in Annex 3, section 3, indents
     3 to 5, 7, 10 and 11,
   The notified body shall:
   4.1 examine and assess the documentation and verify that the
       type has been manufactured in conformity with that
       documentation; it shall also record the items designed in
       conformity with the applicable provisions of the standards
       referred to in Article 5, as well as the items not
       designed, on , the basis of the relevant provisions of the
       abovemehtioned standards;
   4.2 perform or have performed appropriate examinations and the
       tests necessary to verify whether the solutions adopted by
       the manufacturer meet the essential requirements of this
       Directive if the standards referred to in Article 5 have
       not been applied; if the device is to be combined with
       other device (s) in order to operate as intended, proof
       must be provided that it conforms to the essential
       requirements when combined with any such device(s) having
       the characteristics specified by the manufacturer;
 ---pagebreak---                               -68-
   4.3 carry out or ask for the appropriate examinations and the
       tests necessary to verify whether, if the manufacturer has
       chosen to apply the relevant standards, these have
       actually been applied;
   4.4 agree with the applicant on the place where the necessary
       examinations and tests will be carried out.
5. If the type conforms to the provisions of this Directive, the
   notified body shall issue the applicant with an EC type-
   examination certificate.    The certificate shall contain the
   name and address of the manufacturer, the conclusions of the
   examination, the conditions of validity and the data needed
   for identification of the type approved.    The relevant parts
   of the documentation shall be annexed to the certificate and
   a copy shall be kept by the notified body.
6. The applicant shall inform the notified body which issued the
   EC type-examination certificate of any significant change made
   to the approved product.
   Changes to the approved product must receive further approval
   from the notified body which issued the EC type-examination
   certificate wherever the changes may affect conformity with
   the essential requirements or with the conditions prescribed
   for use of the product.       This new approval shall, where
   appropriate, take the form of a supplement to the initial EC
   type-examination certificate.
 ---pagebreak---                               -69-
7. Administrative provisions .
   Other notified bodies may obtain a copy of the EC type-
   examination certificates and/or the supplements thereto. The
   annexes to the certificates must be made available to the
   other notified bodies on reasoned application, after the
   manufacturer has been informed.
 ---pagebreak---                                 -70-
                                                      Annex 6
                          EC VERIFICATION
    EC verification is the procedure whereby the manufacturer or
    his authorized représentative established in the Community
    ensures and declares that the products which have ' been
    subject to the procedure set out in Section 4 conform to the
    type described in the EC type-examination certificate and meet
    the requirements of this Directive which apply to them.
2.1 The manufacturer must take all the measures necessary to
    ensure that the manufacturing process produces products which
    conform to the type described in the EC type-examination
    certificate and to the requirements of the Directive which
    apply, to them.'     Before;, the start of manufacture, the
    manufacturer ' . must     prepare   documents   defining    the
    manufacturing process, in particular as regards sterilization
    and the suitability of starting materials, where necessary,
    and define the necessary testing procedures according to the
    state of the art. All the routine, pre-established provisions
    must be implemented to ensure homogeneous production and
    conformity of the products with the type described in the EC
    type-examination certificate and with the requirements of this
    Directive which apply to them. The manufacturer must affix
    the CE marking in accordance with Article 14 and draw up a
    declaration of conformity covering the products concerned.
 ---pagebreak---                                -71-
2.2 To the extent that for certain aspects the final testing
    according to section 6.3 is not appropriate, adequate in
    process testing, monitoring and control methods shall be
    established by the manufacturer with the approval of the
    notified body. The provisions of Annex 4 section 4 shall
    apply accordingly in relation to the above mentioned approved
    procedures.
3.  The manufacturer must undertake to institute and keep up to
    date a systematic procedure to review experience gained from
    devices in the post-production phase and to implement
    appropriate means to apply any necessary corrective and
    notification action as referred to in Annex 3 section 5.
    The notified body must carry out the appropriate examinations
    and tests in order to verify the conformity of the product
    with the requirements of the Directive either by examining
    and testing every product as specified in section 5 or by
    examining and testing products on . a statistical basis as
    specified in section 6, as the manufacturer decides.
    In as far as the conduct of examinations and tests on a
    statistical basis is not appropriate,- examinations and tests
    may be carried out on a random basis provided that such
    procedure   in conjunction with the measures         taken in
    accordance with section 2.2 ensures an equivalent level of
    conformity.
 ---pagebreak---                               -72-
5. Verification by examination and testing of every product
   5.1 Every product is examined individually and the appropriate
       tests defined in the relevant standard(s) referred to in
       Article 5 or equivalent tests must be carried out in order
       to verify the conformity of the products with the EC type
       described in the type-examination certificate and with the
       requirements of the Directive which apply to them.
   5.2 The notified body must affix, or have affixed, its
       identification number to each approved product and must
       draw up a written certificate of conformity relating to
       the tests carried out.
6. Statistical verification
   6.1 The manufacturer must present the manufactured products in
       the form of homogeneous batches.
   6.2 A random sample is taken from each batch. The products
       which make up the sample are examined individually and the
       appropriate tests defined in the relevant standard(s)
       referred to in Article 5 " or equivalent tests must be
       carried out to verify, where appropriate, the conformity
       of the products with the type described in the EC type-
       examination certificate and with the requirements of the
       Directive which apply to them in order to determine
       whether to accept or reject the batch.
 ---pagebreak---                              - 73 -
  3 Statistical    control   of     products   will   be   based    on
    attributes,  entailing  a sampling     system  ensuring  a   limit
    quality  corresponding   to   a probability    of acceptance    of
    5%, with a non-conformity percentage of between 3 and 7%.
    The sampling method will be established by the harmonized
    standards referred to in Article 5, taking account of the
    specific nature of the product categories in question.
6.4 If the batch    is accepted,    the notified   body  affixes,   or
    has affixed its identification number to each product and
    draws up a written certificate of conformity relating           to
    the tests carried out.      All products    in the batch may be
    put on the market except any in the sample which failed to
    conform.
    If a batch   is rejected    the competent    notified  body   must
    take appropriate measures to prevent the batch from being
    placed on the market.     In the event of frequent      rejection
    of batches, the notified body may suspend the         statistical
    verification.
    The  manufacturer    may,    on   the   responsibility    of   the
    notified  body,   affix the    notified   body's  identification
    number during the manufacturing process.
                                                                       a i
 ---pagebreak---                                74-
                                                     Annex 7
                  EC DECLARATION OF CONFORMITY
                 (PRODUCTION QUALITY ASSURANCE)
1. The manufacturer must ensure application of the quality
   system approved for the manufacture of the products concerned
   and carry out the final inspection, as specified in Section
   3, and is subject to the EC surveillance referred to in
   Section 4.
   The declaration of conformity is the part of the' 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 must affix the.CE marking in accordance with
   Article 14 and draw up a declaration of conformity.
 ---pagebreak---                                -75-
3. Quality system
   3.1 The manufacturer must lodge an application for'assessment
       of his quality system with a notified body.
       The application must include:
       -, all documentation and undertakings referred to' in Annex
       .. 4 section 3.1 and
       - the technical documentation on the types approved and a
          copy of the EC type-examination certificates.
   3.2  Application of the quality system must ensure that the
        products conform to the type described in the EC type-
        examination certificate.
   All the elements, requirements and provisions- adopted by the
   manufacturer for his quality system must be documented in a
   systematic and orderly manner in the form of written policy
   statements and procedures. This quality system documentation
   must permit uniform interpretation of the quality policy and
   procedures such as quality programmes, plans, manuals and
   records.
   It must include in particular an adequate description of:
         the manufacturer's quality objectives;
 ---pagebreak---                             -76-
(b)  the organization of the business and in particular
        the organizational structures, the responsibilities of
        the    managerial   staff  and   their   organizational
        authority where manufacture of the products is
        concerned;
        the methods of monitoring the efficient operation' of
       v
        the quality, system and in particular its ability to
         achieve the desired quality of product, including
         control of products which fail to conform;
 c) the inspection and quality assurance techniques at the
    manufacturing stage and in particular:
    - the processes and procedures which will be used,
      particularly as regards sterilization and purchasing;
    - the product identification procedures drawn up and kept
      up to date from drawings, specifications or other
      relevant documents at every stage of manufacture;
 d) the appropriate tests and trials to be carried out before,
    during and after manufacture, the frequency with which
    they will take place, and the test equipment used;       it
    must be possible adequately to trace back the calibration
    of the test equipment.
 ---pagebreak---                            -77-
3.3 The notified body must audit the quality system to
    determine whether it meets the requirements referred to in
    Section 3.2. It must presume that quality systems which
    implement the relevant harmonized standards conform to
    these requirements.
    The assessment team must include at least one member with
    past   experience of assessments      of   the  technology
    concerned.    The assessment procedure must include an
    inspection on the manufacturer's premises and, in duly
    substantiated cases, on the premises of the manufacturer's
    suppliers    and/or   subcontractors    to   inspect   the
    manufacturing processes.
    The decision must be notified to the manufacturer after
    the final inspection and contain the conclusions of the
    inspection and a reasoned assessment.
3.4 The manufacturer shall inform the notified body which
    approved the quality system of any plan for substantial
    changes to the quality system.
    The notified body must assess the changes proposed and
    verify whether after these changes the quality system
    still meets the requirements referred to in Section 3.2.
    It must notify the manufacturer of its decision. This
    decision must contain the conclusions of the inspection
    and a reasoned assessment.
Surveillance
The provision of Annex 4, section 4, shall apply
                                                               "15
 ---pagebreak---                                -78-
                                                      Annex 8
          STATEMENT AND PROCEDURES CONCERNING DEVICES
                   FOR PERFORMANCE EVALUATION
1. For devices for performance evaluation the manufacturer or
   his authorized representative established in the Community
   shall draw up the statement containing the information
   stipulated in Section 2 of this Annex and ensure that the
   relevant provisions of this Directive are met.
2. The statement shall contain the following information:
      the list of laboratories or other institutions taking part
      in the performance evaluation study;
      in the case of devices for self-testing, the place,
      starting date and scheduled duration for the investigations
      and the number of lay-persons involved.
      a statement that the device in question conforms to the
      requirements of the Directive, apart from the aspects^
      covered   by  the   investigation  and  apart    from   those
      specifically itemised in the statement, and that every
      precaution has been taken to protect the health and safety
      of the patient, user and third parties.
 ---pagebreak---                           -79-
The manufacturer shall also undertake to keep available" for
the competent national authorities the documentation allowing
an understanding of the design, manufacture and performances
of the product, including the expected performances, so as to
allow assessment of conformity with the requirements of this
Directive. This documentation must be kept for a period
ending at least five years after the end of the performance
evaluation.
The manufacturer shall take all the measures necessary for
the manufacturing process to ensure that the products
manufactured conform to the documentation mentioned in the
first paragraph.
                                                              HI
 ---pagebreak---                            -80-
                                                  Annex 9
     CRITERIA FOR THE DESIGNATION OF NOTIFIED BODIES
The notified body, its Director and the assessment and
verification staff shall not be the designer, .manufacturer,
supplier, installer or user of the devices which they
inspect, nor the authorized representative of any of these
persons. They may not be directly involved in the design,
construction, marketing or maintenance of the devices, nor
represent the parties engaged in these activities. This in no
way precludes the possibility of exchanges of technical
information between the manufacturer and the body.
The notified body and its staff must carry out the assessment
and verification operations with the highest degree of
professional integrity and the requisite competence in the
field of medical devices 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 results of the verifications.
Should the notified body subcontract specific tasks connected
with the establishment and verification of the facts, it must
first ensure that the subcontractor meets the provisions of
the Directive. The notified body shall keep at the disposal
of the national authorities the relevant documents assessing
the subcontractor's qualifications and the work carried out
by the subcontractor under this Directive.
                                                               <\<k
 ---pagebreak---                               -81-
3. The notified body must be able to carry out all the tasks
   assigned to such bodies by one of Annexes 3 to 7 and for
   which it has been notified, whether these tasks are carried
   out by the body itself or on its responsibility. In
   particular, it must have the necessary staff and possess the
   facilities needed to "perform properly the technical and
   administrative tasks entailed in assessment and verification.
   It must also have access to the equipment necessary for the
   verifications required.
4. The notified body must have:
      sound vocational training covering all the assessment and
      verification operations for which the body has been
      designated;
      satisfactory knowledge of the rules on the inspections
      which they carry out and adequate experience of such
      inspections;
      the ability required to draw up the certificates, records
      and reports to demonstrate that -the inspections have been
      carried out.
5. The impartiality of the inspection staff must be guaranteed.
   Their remuneration must not depend on the number of
   inspections carried out, nor on the results of the
   inspections.
 ---pagebreak---                               -82-
6. The body must take out civil liability insurance, unless
   liability is assumed by the State under domestic legislation
   or the Member State itself carries out the inspections
   directly.
7. The staff of the inspection body are bound to observe
   professional secrecy with regard to all information gained in
   the course of their duties (except vis-à-vis the competent
   administrative authorities of the State in which their
   activities are carried out) under this Directive or any
   provision of national law putting it into effect.
 ---pagebreak---                                  83-
                                                       Annex 10
                     CE MARKING OF CONFORMITY
The CE conformity marking    shall   consist of the  initials "CE"
taking the following form :
     If the marking is reduced or enlarged the proportions given
     in the above graduated drawing must be respected.
     The various components of the CE marking must have
     substantially the same vertical dimension, which may not be
     less than 5 mm. This minimum dimension may be waived for
     small-scale devices.
 ---pagebreak---                                                                                                ANNEX
                                              DRAFT
                       DECISION OF THE EEA JOINT COMMITTEE
                                             No. [        ,..]
                      amending Annex II, Technical regulations, standards,
                        testing and certification, to the Agreement on the
                                      European Economic Area
THE EEA JOINT COMMITTEE,
Having regard to the Agreement on the European Economic Area, as adjusted by the Protocol
Adjusting the Agreement on the European Economic Area, hereinafter referred to as the
Agreement, and in particular Article 98 thereof;
Whereas Directive ....../ /EEC of..../ /             (OJNo. L            ...) on in vitro diagnostic
medical devices is to be integrated into the Agreement,
HAS DECIDED AS FOLLOWS :
                                                Article 1
The following shall be inserted in Annex II to the Agreement :
                            Directive       / /EC on in vitro diagnostic
                                            medical devices
                                                Article 2
The texts of Directive ..../...../.EC in the Finnish, Icelandic, Norwegian and Swedish languages,
which are annexed to the respective language versions of this decision, are authentic
                                                Article 3
This Decision shall enter into force on [       ][     ], provided that all the notifications under
Article 103(1) of the Agreement have been made to the EEA Joint Committee
 ---pagebreak---                                              -2-
                                           Article 4
This decision shall be published in the EEA Section of, and in the EEA Supplement to, the
Official Journal of the European Communities
                                                                  For the EEA Joint Committee
                                                                                  The President
                                                                                The Secretaries
                                                                    to the EEA Joint Committee
                                                                                       ANNEX
 ---pagebreak---                             FINANCIAL STATEMENT
        Financial implications (details for publication in the working papers)
1.  TITLE OF OPERATION
    Proposal for a Directive on in vitro diagnostic medical devices
2.  BUDGET HEADING
    B5-300          Measures concerning the internal market; Operating appropriations
    B5-7210          Development of a data interchange system
3.  LEGAL BASIS
    Article 100a,of the EC Treaty.
4.  DESCRIPTION OF OPERATION
4.1 Specific objectives of operation: Jhe^specific objective of this operation is to
    establish the internal market in in-vitro diagnostic medical devices.
    This proposal is intended to complement the existing Directives 90/385/EEC (on
    active implantable medical devices) and 93/42/EEC (on medical devices) by
    introducing Community legislation governing the placing on the market of in vitro
    diagnostic medical devices. The Directive aims at ensuring the safety and
    protecting the health of patients, users of the devices concerned and third parties.
    Harmonized rules will ensure free movement of the devices and prevent the
    emergence of new barriers to trade.
 ---pagebreak---                                           2-
    Following the principles laid down in the new approach, the Directive provides for
    harmonization of the essential safety requirements and for the conformity
    assessment procedures which in vitro diagnostic medical devices must satisfy when
    they are placed on the market. Effective implementation of this Directive will
    entail:
            drafting of harmonized standards by the CEN/CENELEC; if these are
            applied, conformity with the- essential requirements in the Directive will be
            presumed;
            establishment by the parties concerned and submission by the Commission
            of the guidelines necessary to ensure uniform application of the Directive,
            on its scope, the principles to be applied, the means to be employed to
            meet the essential requirements, etc.;
            concertation between the notified bodies on the certification procedures;
            exchanges of information between the Member States concerning
            application and monitoring of the Directive;
            management by the Commission of the procedures for implementing the
            safeguard clauses, which will imply seeking the opinion of high-level
            experts.
4.2 Duration: Ad hoc measure.
4.3 Target population: Every citizen in the Community is a potential user of the
    devices covered by the Directive, since the products are employed in the health
    care sector.
 ---pagebreak---                                       -3-
5. CLASSIFICATION OF EXPENDITURE
   5.1    Non-compulsory expenditure.
   5.2    Differentiated appropriations.
   5.3   No revenue is expected.
6. TYPE OF EXPENDITURE
   The expenditure will be on:
   (a)    standardization: The proposal for a Directive lays down the essential
          requirements. Article 5 refers to harmonized standards. As with the other
          new approach Directives, the Commission plans to give the
          CEN/CENELEC a mandate to draft the relevant harmonized standards.
          This mandate will cover technical formulation of the essential requirements
          defined in the proposal. It will be governed by the framework contract of
          15 September 1992, which provides for financial support from the
          Commission.
   (b)    development of a data interchange system: The registration procedures for
          manufacturers (Article 10) and the vigilance system (Article 11) involve
          exchanges of official data between the Member States, the parties
          concerned and the Commission. The development of a system facilitating
          data interchange will therefore be essential if the directive is to be fully
          effective. To this end, the profiles of the data to be exchanged must be
          established, procedures must be devised and common software must be
          provided.
 ---pagebreak---                                          4-
6.1 100% subsidy: none.
6.2 Subsidy for joint financing with other sources in the public and/or private sector:
    none.
6.3 Interest subsidy: none.
6.4 Other: none.
6.5 Should the operation prove an economic success, is there provision for all or part
    of the Community contribution to be reimbursed? No.
6.6 Will the proposed operation cause any change in the level of revenue? No.
 ---pagebreak---                                           -5-
7.    FINANCIAL IMPACT
7.1   Method of calculating total cosî of operation
7.1.1 Standardization
      (a)    Estimated cost of:
             - drafting the standards: In the order of 25 harmonized standards will have
             to be drafted.
             The funding will depend on the work given to the contractors.
             On average, the estimated financial contribution from the Commission for
             drafting a standard is a flat rate of ECU 50 000. Total expenditure of
             ECU 1.25 million is expected.
             - developing a data interchange system between the Member States.
             The cost of a project such as referred to in point 6b, to be carried out in
              1996/1997, is estimated at ECU 300 000.
 ---pagebreak---                                                  -6-
            (b)     The indicative schedule of appropriations could be as follows
                    Commitment appropriations                      Payment appropriations
                           (1.000 ECU                                    (1.000 ECU)
                 1995                           750                           350
                 1996                           650                           500
                 1997                           150                           300
                 1998                                                         300
                 1999                                                          100
                                                1550                          1550
    7.2     Itemized breakdown of cost
                                                                                  ECU
           BREAKDOWN                     1994                1995             PERCENTAGE
                                      BUDGET          PRELIMINARY                CHANGE
                                                     DRAFT BUDGET
     Standardization (B5-300)              -                                         -
     * Mandate                                             750 000
    7.3     Indicative schedule of commitment appropriations
                                                                                  ECU
                                                                INDICATIVE SCHEDULE
                        1994             1995           1996       1997      1998    1999 2000
                      BUDGET        PRELIMINARY
                                    DRAFT BUDGET
Standardization                         750 000       500 000
(B5-300)
Mandate
Development of a                                      150 000    150 000
data interchange
system between the
Member States
(B5-7210)
                                                                                               l<
 ---pagebreak--- 8.  FRAUD PREVENTION MEASURES
    The Commission verifies the subsidies or receipt of the services and preparatory,
    feasibility or evaluation studies ordered before payment, taking account of the
    contractual obligations and of the principles of economy and sound financial or
    general management. All agreements or contracts concluded between the
    Commission and recipients of payments include fraud prevention clauses (on
    monitoring, submission of reports, etc.).
9.  ELEMENTS OF COST-EFFECTIVENESS ANALYSIS
9.1 Objectives
    This new approach Directive is a measure to complete the internal market. The
    reference to harmonized standards is part of the Commission's multiannual
    programme to support reinforcement and extension of European standardization.
9.2 Grounds for the operation
    The. national legislation on in vitro .diagnostic medical devices is extremely
    heterogeneous and takes different approaches to safety which make application of
    the principle of mutual recognition delicate.
                                                                                      t\o
 ---pagebreak---       The diverging requirements imposed by the national systems, both on the products
      and on the procedures for placing them on the market, give rise to enormous
      wastage of human and financial resources at the expense of the manufacturers and
      of the Member States.
      The Community procedures will avoid multiple repetition with the same objective.
      In addition, the harmonized requirements will allow industry to make savings on
      unit production costs.
      The harmonization of standards is designed to pool resources and thereby avoid
      duplication of expenditure by the Member States.
      All in all, the resources required from the Community budget are only a small
      proportion of the total resources which the Member States and parties concerned
      will release for the common good as a result of the operation.
9.3   Monitoring and evaluation of the operation
9.3.1 Performance indicators selected
               degree of harmonization of standards (number of standards);
               number of certifications carried out;
               number of reports of undesirable incidents;
               number of infringement procedures.
                                                                                       \\\
 ---pagebreak---                                              9-
9.3.2 Details and frequency of planned evaluation:
               regular progress reports on standardization under Council
               Directive 83/189/EEC, at least once a year.
9.4   Coherence -with financial programming
9.4.1 The operation is included in DG Ill's financial programming.
9.4.2 Broader objectives defined in DG Ill's financial programming: not applicable.
9.4.3 Main factors of uncertainty which could affect the specific results of the operation:
      not applicable.
10.   ADMINISTRATIVE EXPENDITURE (PART A OF THE BUDGET)
10.1  The proposed operation will involve an increase in the number of Commission
      staff for administration of the Directive.
      The procedures concerning the safeguard clauses, monitoring of European
      standardization and administrative cooperation presuppose the availability of staff
      capable of administration and evaluation of analyses and technical or legal
      opinions.
      The staff requirements will be covered either by internal redeployment or by a
      Commission decision allocating resources in the budgetary procedure. It is
      estimated that Unit III.D.2 will require one grade A official from 1995 on.
 ---pagebreak---                                             10-
                           FINANCIAL STATEMENT
               Financial implications (details for internal information)
10.2 Amount of staff and operating expenditure generated by the proposed operation
     subject to the outcome of the budgetary procedure and the decision allocating
     resources
     10.2.1    Expenditure on staff covered by the Staff Regulations
               Titles Al and A2 : ECU 90 000 per year
               This item should be covered either through redeployment or under the
               allocation of resources decided each year by the Commission.
     10.2.2    Other expenditure from Part A of the budget:
               Budget items concerned and type of expenditure
               (a) A2500: Meetings of experts: To promote uniform application of
                            the Directive, the Commission plans regular meetings with
                            the experts from the Member States, representatives of the
                            notified bodies and the European federations to coordinate
                            their activities and harmonize their practices.
                            Estimated annual cost (from 1996 on):
                            24 experts x 3 meetings per year x ECU 658 per expert per
                            meeting = ECU 47.376 per year.
 ---pagebreak---                                              11
                   (b) A1178 Technical assistance
                                       Consultants:   In the pre-impiementation phase
                                       (1996-1997) consultants' fees are estimated to total
                                       ECU 25 000 per year.
                   (c) A 2600" Studies
                                       Technical opinions:       The technical opinions
                                       required to administer the safeguard clause
                                       procedures will be funded by study contracts.
                                       ECU 40 000 per year must be earmarked for this
                                       purpose from 1998 on.
10.3    Itemized breakdown of cost (Part A of the budget)
                                                                                   ECU
                               1994 BUDGET              1995            PERCENTAGE
      BREAKDOWN
                                                   PRELIMINARY              CHANGE
                                                  DRAFT BUDGET
 (a) Al, A2                                            90.000
 (b) A2550: meetings
 Member States                         -.                                       -
 (c) A l l 78 /technical
 assistance (safeguard                                 25.000
 clauses)
        or Al 178 according to nomenclature for 1995.
        or Al 178 according to nomenclature for 1995.
 ---pagebreak---                                                 - 12
    10.4     Indicative schedule of appropriations
                                                                               ECU
                                                            INDICATIVE SCHEDULE
                              1994        1995       1996   1997     1998    1999    2000
                            BUDGET
(a)Al,A2                               90.000      90.000  90.000  90.000  90.000   90.000
(b) Meetings with the       -                      47 376  47 376  47 376  47 376   47 376
Member States (A2500)
(c) Studies and
consultations
* Consultants (Al 178)                  25 000     25 000  25 000
* Technical opinions                                               40 000  40 000   40 000
(A2600)
TOTAL                       -          115.000     162.376 162.376 177.376  177.376 177.376
 ---pagebreak---                             IMPACT ASSESSMENT FORM
TITLE OF PROPOSAL:
Proposal for a Directive of the European Parliament and the Council on in vitro
diagnostic medical devices.
REFERENCE NUMBER: 2111.2.1.1
       THE PROPOSAL
       This proposal is for a new approach Directive based on Article 100a of the
       Treaty. It is intended to achieve the following objectives:
           to complete the harmonization started by Directive 90/385/EEC on active
           implantable medical devices and Directive 93/42/EEC on medical devices
           for the products concerned;
           to ensure free movement of in vitro diagnostic medical devices by
           harmonizing the national legislation to protect the health and safety of
           patients and users;
           to remove the existing barriers created by the diverging regulations and
           prevent the emergence of new barriers. This proposal is essential to
           prevent the national legislation implementing the abovementioned
           Directives from deepening the differences;
           to create a favourable environment with uniform conditions of competition
           to enable the industry to benefit from the scale of the European Economic
           Area and to help make European industry more competitive.
 ---pagebreak---                                       -2-
2. THE IMPACT ON BUSINESS
   (a) Nature of the businesses concerned
       The in vitro diagnostic device industry is highly developed in the
       Community and the EFTA countries. Estimates put world production in
       1992 at ECU 12.2 billion, of which 39% was from the USA, 38% from,
       Western Europe and 12% from Japan.
       Most of the 350 to 400 European undertakings in this sector are small or
       medium-sized businesses. Research activities are intense and account for an
       estimated 15 to 20% of the jobs in this industry.
   (b) Geographical distribution of the industry and market
       In Europe the leading manufacturers of in vitro diagnostic medical devices
       are Germany, Switzerland, France, Sweden, the Netherlands, the United
       Kingdom, Italy and Belgium. In 1992 the total market of ECU 4.6 billion
       broke down as follows: Germany 25 % ; Italy 23 % ; France 18 % ; Spain
       12%; United Kingdom 4%; Belgium 3.5%; Switzerland 3%; Austria
       3 % ; Netherlands 2 % ; Sweden 2 % ; Finland 1 % ; Denmark 1 % ; Norway
       1%; Ireland 0.5% (source: European Diagnostic Manufacturers
       Association, EDMA).
   (c) Are these businesses in regions eligible for regional aid in the Member
       States and under the ERDF?
       No particular concentration in these regions is known.
                                                                                   u>
 ---pagebreak---    WHAT WILL BUSINESS HAVE TO DO TO COMPLY WITH THE
   PROPOSAL?
   The proposal lays down the essential requirements which devices placed on the
   market must meet in order to protect the health and safety of patients, users and
   third parties. These requirements will be given firmer shape by harmonized
   standards which will be drafted by the European standardization organizations
   CEN/CENELEC and will remain voluntary.
   Before, placing their devices on the market, manufacturers must ensure that they
   comply with the regulations. The conformity assessments for an extremely large
   proportion of the devices will be conducted solely on the manufacturers'
   responsibility, without the intervention of any third party.
   The Directive will require manufacturers to apply the appropriate quality
   assurance principles for the devices manufactured.
   However, in thé case of devices particularly sensitive for health protection
   purposes, particularly AIDS and hepatitis tests, third party certification of the
   design and manufacture of the devices is required.
   For monitoring purposes, manufacturers must notify one of the competent
   authorities in the Community of their marketing activities and of any
   undesirable incidents.
4. WHAT ECONOMIC EFFECTS IS THE PROPOSAL LIKELY TO HAVE?
   (a) On employment
        The proposal will have no particular impact on employment. However, the
        requisite adaptation to the new rules will help to safeguard existing jobs
        and, in certain cases, to create new ones.
 ---pagebreak---                                        4-
(b) On investment and the creation of new businesses
    The proposal will have no direct impact on business start-ups or investment.
    Conditions on the single market to be created could have consequences for
    distribution of the devices. It will be possible to organize distribution
    according to the needs of the European market without having to maintain
    separate distribution systems in each Member State.
(c) On the competitive position of businesses
    Initially, adaptation to the new requirements and implementation of the
    quality principles, where still necessary, will give rise to extra costs. The
    three-year transition period following adoption of the Directive will make it
    possible to spread these costs over this entire period.
    Once the adjustments have been completed, businesses will be able to
    benefit from the greater rationalization. Harmonization of the diverging
    regulatory systems will cut the costs caused by the current divergency. The
    European dimension of the market in turn will allow economies of scale.
    Businesses will face tougher competition from both inside and outside the
    Community. The abovementioned effects of the proposal will make
    European businesses more competitive at international level.
    Once the Community legislation is adopted the Community will be able to
    use it in its international negotiations to improve access for the European
    industry to markets in third countries.
                                                                                  U1
 ---pagebreak---                                         -5-
   (d) On public health
        By ensuring that the devices placed on the market are reliable, the Directive
        will provide greater protection for public health. In particular, the
        performance and reliability of in vitro diagnostic devices will make it easier
        to take medical decisions at an early stage of treatment and yield savings in
        health care costs.
5. DOES THE PROPOSAL CONTAIN MEASURES TO TAKE ACCOUNT OF
   THE SPECIFIC SITUATION OF SMALL AND MEDIUM-SIZED FIRMS?
   The proposal contains no specific measures applicable solely to small firms.
   The Directive is limited to the essential protection requirements, which will be
   laid down in voluntary harmonized standards, and will therefore provide a legal
   framework which can be applied flexibly. The introduction of harmonized
   standards will make it easier to comply with the Directive, particularly for small
   firms. The manufacturer's declaration proposed for a very large proportion of
   the devices will limit the costs generated by the regulations and thus take
   particular account of the interests of small businesses.
   The Commission will continue to ensure close involvement by the European
   federations representing the vast majority of small firms in this industry when
   implementing the proposed Directive.
6. CONSULTATION AND OPINION OF THE TWO SIDES OF INDUSTRY
   Since 1991 the Commission has consulted the industrial and trade federations
   concerned with the aid of various working papers. Four meetings were held to
   examine a working paper at various stages. In addition, in 1992 and 1993 the
   EDMA, assisted by the Commission, organized two workshops specially on the
   proposal. Many bilateral meetings have been held with the parties concerned
   and talks on the subject have been given at numerous conferences.
 ---pagebreak---                                     -6-
The following federations and organizations have been consulted:
(a) Manufacturers
    EDMA (European Diagnostic Manufacturers Association)
    EUROM (European Federation of Precision, Mechanical and Optical
    Industries)
    ELPA (European Laboratory Plastics Association)
(b) Users
    1FCC (International Federation of Clinical Chemistry)
     ECCLS (European Council for Clinical and Laboratory Standards)
     ICSH (International Council for Standardization in Haematology)
     ESCMID (European Society for Clinical Microbiology and Infectious
     Diseases)
     WASP (World Association of Societies of Pathology - European section).
The parties concerned have recognized the need for harmonization with the aid
of a Directive and support the principles established in this proposal.
The EDMA, which represents more than 300 small firms, and the other
industrial federations mentioned above have stressed the need to uphold the
principle that the conformity assessment for a large proportion of the devices
can be conducted on the manufacturers' responsibility. Under these
circumstances, the introduction of the vigilance procedures combined with
notification of new devices are recognized as adequate monitoring
arrangements. Consequently, in the industry's view, any moves to extend third
party certification could upset the balance of the monitoring measures proposed.
 ---pagebreak---                                                                     ISSN 0254-1475
                                                             COM(95) 130 final
                                              DOCUMENTS
EN                                                                         06  15
                                     Catalogue number : CB-CO-95-140-EN-C
                                                              ISBN 92-77-87648-4
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