CELEX: 51996PC0643
Language: en
Date: 1996-12-20
Title: Amended proposal for a EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE AMENDING THE DIRECTIVE PROPOSAL ON IN VITRO DIAGNOSTIC MEDICAL DEVICES

COMMISSION OF THE EUROPEAN COMMUNITIES
                                             Brussels, 20.12.1996
                                             COM(96) 643 final
                                             95/0013 (COD)
                           Amended proposal for a
        EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE
                               AMENDING
THE DIRECTIVE PROPOSAL ON IN VITRO DIAGNOSTIC MEDICAL DEVICES
         (presented by the Commission pursuant to Article 189 a (2)
                             of the EC-Treaty)
 ---pagebreak---  ---pagebreak---                                    EXPLANATORY MEMORANDUM
In response to the European Parliament's opinion of 14 March 1996 on the proposal for a European
Parliament and Council Directive on in vitro diagnostic medical devices, pursuant to Article 189a(2)
of the EC Treaty the Commission has decided to amend the abovementioned proposal.
The Commission has approved the amendments concerning:
*       improvements to the wording to clarify the text (amendments 2, 5, 10, 11, 24, 28, 29 and
        30);
*       clearer demarcation of the scope in comparison with Directive 89/392/EEC relating to
        machinery (amendment 4);
*       the clarification that the aspects concerning medical prescriptions for devices are not
        affected by the harmonization (amendment 15);
*       the scope, to include in vitro diagnostic medical devices for health monitoring purposes
        (amendment 8);
 *      the tightening-up of the protection requirements with a view, in particular, to minimizing the
        risks, including the risks relating to the packaging (amendments 1, 3, 41, 42, 44, 46, 47 (in
        part), 48,49, 50 and 58);
 *      the clarification of the powers of the Member States' authorities and the strengthening of
        their market surveillance powers (amendments 6, 14, 16, 23, 25 and 29);
 *      the establishment of a European Union databank on the products placed on the market
        (amendments 21 (in part) and 26);
 *      extension of the group of in vitro diagnostic devices which must be submitted to third-party
        certification before they are placed on the market (amendment 56);
 *       the inclusion in the scope of Directive 93/42/EEC of certain medical devices manufactured
        using products derived from human tissues or cells (amendments 33, 36, 37, 38 and 39);
 *       the amendments to Directive 93/42/EEC to bring it closer into line with this Directive
        (amendments 30, 32 and 34).
         OJ L 183, 29.6.1989, p. 9 , last modified by Directive 93/68/EEC, OJ L 220, 30.8.1996, p. 1
 ---pagebreak--- The Commission has not approved the amendments concerning:
*     deletion of the 19th recital (amendment 7). This recital states the grounds for several
      provisions in the proposal;
*     the obligation that the information accompanying the products placed on the market must be
      available in the national language(s) (amendments 17 and 35). The proposal already ensures
      adequate protection for users, while reserving for the Member States the right to require
      availability in the national languages;
*     the type of Committee (amendment 18). The measures which must be taken in the context
      of the Committee procedure will have an impact on health protection standards;
      consequently, for the sake of consistency with the other Directives on medical devices,
      procedure Ilia in Council Decision 87/373/EEC must be retained;
*     application of the transitional system for notification of devices placed on the market to all
      Member States (final part of amendment 21). No such system is necessary; it would be
      better to establish a Community system as soon as the Directive enters into force;
*     the list of products in Annex 2 for which the Directive requires third-party certification
      before they are placed on the market (amendments 55, 57 and 71). In view of their design,
      devices for self-testing are already subject to third-party certification, pursuant to the
      Commission proposal. For the other products concerned, the proposal already provides
      adequate protection. There is no justification for tightening up the requirements for
      third-party certification;
*     the amendment to the definition of "placing on the market" in Directive 93/42/EEC
      (amendment 31). The amendments made to Directive 93/42/EEC by this Directive must be
      limited to cases concerning consistency between the two Directives;
*     the amendment to Directive 89/392/EEC relating to machinery (amendment 40).
      Amendment 4, which supports retention of the Commission proposal, has been preferred;
*     certain technical points (amendments 20, 43 and 54). No amendments are needed on these
      points.
 ---pagebreak---                     INITIAL TEXT                                          MODIFIED TEXT
I.                                                 Recital 3
Whereas the harmonization of national legislations       Whereas the harmonization of national
is the only means of removing these barriers to free     legislations is the only means of removing these
trade and preventing new barriers; whereas this          barriers to free trade and preventing new barriers;
objective cannot be achieved in a satisfactory           whereas this objective cannot be achieved in a
manner at another level by the individual Member         satisfactory manner at another level by the
States; whereas this Directive only lays down            individual Member States; whereas this Directive
necessary and sufficient requirements for the free       only lays down necessary and sufficient
circulation of the in vitro diagnostic medical devices   requirements for the free circulation, in the best
to which it is applicable;                               possible safety conditions of the in vitro
                                                         diagnostic medical devices to which it is
                                                         applicable;
II.                                                 Recital 5
Whereas in vitro diagnostic medical devices should        Whereas in vitro diagnostic medical devices
provide patients, users and third parties with a high     should provide patients, users and third parties
level of protection and attain the performance levels     with a high level of health protection and attain
attributed to them by the manufacturer; whereas,          the performance levels originally attributed to
therefore, the maintenance or improvement of the          them by the manufacturer; whereas, therefore, the
level of protection attained in the Member States is      maintenance or improvement of the level of
one of the essential objectives of this Directive;        health protection attained in the Member States is
                                                          one of the essential objectives of this Directive;
HI.                                                   Recital 6
Whereas, in accordance with the principles set out in      Whereas, in accordance with the principles set out
the Council resolution of 7 May 1985 concerning a          in the Council resolution of 7 May 1985
new approach to technical harmonization and                concerning a new approach to technical
standardization, rules regarding the design and            harmonization and standardization, rules
manufacture of relevant products must be confined to       regarding the design, manufacture and packaging
the provisions required to meet the essential              of relevant products must be confined to the
requirements; whereas because they are essential,          provisions required to meet the essential
such requirements should replace the corresponding         requirements; whereas because they are essential,
national provisions; whereas the essential                 such requirements should replace the
requirements, including requirements to minimize and       corresponding national provisions; whereas the
reduce risks, should be applied with discretion, taking    essential requirements, including requirements to
into account the technology and practice at the time of    minimize and reduce risks, should be applied with
design and of technical and economic considerations        discretion, taking into account the technology and
compatible with a high level of protection of health       practice at the time of design and of technical and
and safety                                                 economic considerations compatible with a high
                                                           level of protection of health and safety
 ---pagebreak---                                                   -5-
                   INITIALTEXT                                             MODIFIED TEXT
IV.                                                Recital 9a (new)
                                                          Whereas mechanical laboratory equipment
                                                          especially designed for in vitro diagnostic
                                                          examinations falls within the scope of this
                                                          Directive; whereas, therefore, in order to
                                                          harmonize the relevant Directives, Directive
                                                          89/392/EEC2 as last amended by Directive
                                                          93/68/EEC3 should be appropriately amended to
                                                          bring it into line with this Directive
V.                                                  Recital 15
Whereas the list of in vitro diagnostic medical            Whereas the list of in vitro diagnostic medical
devices to be subjected to third party conformity          devices to be subjected to third party conformity
assessment needs updating, taking account of               assessment needs updating, taking account of
technological progress and of evolution in the             technological progress and of evolution in the
domain of protection of health; whereas such               domain of protection of health; whereas such
updating measures must be taking in line with the          updating measures must be taking in line with the
procedure Ilia as laid down in Council Decision            procedure Ilia as laid down in Council Decision
87/373/EEC; whereas a system of adverse incident           87/373/EEC; whereas an agreement on a "modus
reporting (vigilance) constitutes a useful tool for the    vivendi" between the European Parliament, the
surveillance of the market, including the                  Council and the Commission concerning the
performance of new devices, whereas information            implementation measures of the acts adopted
obtained from vigilance as well as from external           pursuant to the procedure referred to in Article
quality assessment schemes becomes useful for              189b of the EC Treaty took place on 20
decision-making on classification of devices.              December 1994; whereas a system of adverse
                                                           incident reporting (vigilance) constitutes a useful
                                                           tool for the surveillance of the market, including
                                                           the performance of new devices placed on the
                                                           market, whereas information obtained from
                                                           vigilance as well as from external quality
                                                           assessment schemes becomes useful for decision-
                                                           making on classification of devices.
        OJL 183, 29.6.1989, p. 9
        OJL 220, 30.8.1993, p. 1
 ---pagebreak---                                                   -6-
                    INITIALTEXT                                            MODIFIED TEXT
VI.                                                  Recital 18
Whereas the competent authorities in charge of            Whereas the competent authorities in charge of
market surveillance must be able, particularly in         market surveillance must be able, particularly in
emergencies, to contact the manufacturer or his           emergencies, to contact the manufacturer or his
authorized representative established in the              authorized representative established in the
Community; whereas cooperation and exchange of            Community, in order to take any protection
information between Member Sates are necessary in         measures that should prove necessary; whereas
view of uniform application of this Directive, in         cooperation and exchange of information between
particular for the purpose of market surveillance;        Member Sates are necessary in view of uniform
                                                          application of this Directive, in particular for the
                                                          purpose of market surveillance;
VII.                                              ARTICLE 1 (1)
 1. This Directive shall apply to in vitro diagnostic      1. This Directive shall apply to in vitro diagnostic
medical devices and their accessories. For the             medical devices, including therapy monitoring
purposes of this Directive, accessories shall be           devices for diagnostic purpose , and their
treated as in vitro diagnostic medical devices in their    accessories. For the purposes of this Directive,
own right. Both in vitro diagnostic medical devices        accessories shall be treated as in vitro diagnostic
and accessories shall hereinafter be termed devices.       medical devices in their own right. Both in vitro
                                                           diagnostic medical devices, including therapy
                                                           monitoring devices for diagnostic purposes and
                                                           accessories shall hereinafter be termed devices.
VIII.                                        ARTICLE 1 (2) (b), 1st subparagraph
b) "in vitro diagnostic medical device" means any           b) "in vitro diagnostic medical device" means any
medical device which is a reagent, reagent product,         medical device which is a reagent, reagent
calibrator, control material, kit, instrument, apparatus,   product, calibrator, control material, kit,
equipment or system whether used alone or in                instrument, apparatus, equipment or system
combination, intended by the manufacturer to be used        whether used alone or in combination, intended by
in vitro for the examination of specimens including         the manufacturer to be used in vitro for the
blood and tissue donations, derived from the human          examination of specimens including blood and
body, solely or principally for the purpose of              tissue donations, derived from the human body,
providing information concerning a physiological            solely or principally for the purpose of providing
state, state of health or disease or congenital             information concerning a physiological state,
abnormality or to determine the safety and                  pathological state or congenital abnormality or to
compatibility with potential recipients.                    determine the safety and compatibility with
For the purpose of this directive, a specimen               potential recipients.
receptacle, whether evacuated or not, specifically          For the purpose of this directive, a specimen
intended by its manufacturer to contain a specimen          receptacle, whether a vacuum-type or not,
for the purpose of in vitro diagnostic examination is       specifically intended by its manufacturer to
considered to be a device;                                  contain a specimen for the purpose of in vitro
                                                            diagnostic examination is considered to be a
                                                            device;
 ---pagebreak---                                                   7-
                    INITIAL TEXT                                       MODIFIED TEXT
IX.                                             ARTICLE l(2)(e)
(e) "Device for performance evaluation" means any       (e) "Device for performance evaluation" means
device intended by the manufacturer to be subject to    any device intended by the manufacturer to be
one or more performance evaluation studies in           subject to one or more performance evaluation
clinical laboratories or in other appropriate           studies in laboratories for medical analysis or in
environments outside his own premises;                  other appropriate environments outside his own
                                                        premises;
X.                                                ARTICLE 2
Member States shall take all necessary steps to ensure   1. Member States shall take all necessary steps
that devices may be placed on the market and put into    to ensure that devices may be placed on the
service only if they comply with the requirements laid   market and put into service only if they comply
down in this Directive when properly installed,          with the requirements laid down in this
maintained and used in accordance with their intended    Directive when properly supplied, installed,
purpose.                                                 maintained and used in accordance with their
                                                         intended purpose.
                                                         2. Member States shall continuously monitor
                                                         the safety and quality of devices placed on the
                                                         market.
XL                                               ARTICLE 3a (new)
                                                          This Directive shall not affect national laws
                                                          which provide for the supply of diagnostic
                                                          medical devices by a medical prescription.
XII.                                            ARTICLE 4(2)
2. At trade fairs, exhibitions, demonstrations,        2. At trade fairs, exhibitions, demonstrations or
Member States shall not create any obstacle to the     scientific and technical meetings. Member States
showing of devices which do not conform to this        shall not create any obstacle to the showing of
Directive, provided that a visible sign clearly        devices which do not conform to this Directive,
indicates that such devices cannot be marketed or      provided that a visible sign clearly indicates that
put into service until they have been made to          such devices cannot be marketed or put into
comply.                                                service until they have been made to comply.
 ---pagebreak---                                                    8-
                   INTTIALTEXT                                           MODIFIED TEXT
XIII.                                         ARTICLE 10, title
Registration of manufacturers                           Registration of manufacturers and devices
XIV.                                          ARTICLE 11(3)
3. After carrying out an assessment, if possible        3. After carrying out an assessment, if possible
together with the manufacturer, Member States shall,    together with the manufacturer, Member States
without prejudice to Article 8, immediately inform      shall, without prejudice to Article 8, immediately
the Commission and the other Member States of the       inform the Commission and the other Member
incidents referred to in paragraph 1 for which          States of the incidents referred to in paragraph 1
relevant measures have been taken or are                for which relevant measures, including possible
contemplated.                                           withdrawal, have been taken or are contemplated.
XV.                                           ARTICLE 11(4), introduction
4. Where, in the context of notification referred to in  4. Where, in the context of notification referred to
Article 10, a device notified, bearing a CE marking,     in Article 10, a device notified, bearing a CE
is a "new" product, the manufacturer shall indicate      marking, is a "new" product, the manufacturer
this fact on his notification. The competent authority   shall indicate this fact on his notification. The
so notified may at any time within the following two     competent authority so notified may at any time
years and on justified grounds, require the              within the following two years and on justified
manufacturer to submit a report relating to the          grounds, require the manufacturer to submit a
experience with the device subsequent to its being       report relating to the experience gained with the
placed on the market. For this purpose, a device is      device subsequent to its being placed on the
 "new" if:                                               market. For this purpose, a device is "new" if
XVI.                                           ARTICLE ll(5a) (new)
                                                          5a. In addition, the data provided by the
                                                          manufacturers in accordance with Article 10 shall
                                                          be stored in a Community database accessible to
                                                          the competent authorities to enable them to
                                                          conduct vigilance on a well-informed basis. Such
                                                          data is to be forwarded in a standardized format.
 ---pagebreak---                                                   -9-
                    INITIALTEXT                                            MODIFIED TEXT
XVII.                                           ARTICLE 13(2)
2. Member States shall apply the criteria set out in      2. Member States shall apply the criteria set out in
Annex 9 for the designation of bodies. Bodies that        Annex 9 for the designation of bodies. Bodies
meet the criteria laid down in the national standards     that meet the criteria laid down in the national
which transpose the relevant harmonised standards         standards which transpose the relevant
shall be presumed to meet the relevant criteria.          harmonised standards shall be presumed to meet
                                                          the criteria applicable in accordance with the said
                                                          Annex 9.
XVIII.                                          ARTICLE 16(2)
2. In the event of a decision as referred to in            2. In the event of a decision as referred to in
paragraph 1, the manufacturer, or his authorized           paragraph 1, the manufacturer, or his authorized
representative established in the Community, shall         representative established in the Community,
have an opportunity to put forward his viewpoint in        shall have an opportunity to put forward his
advance, unless such consultation is not possible          viewpoint in advance, unless such consultation is
because of the urgency of the measure to be taken.         not possible because of the urgency of the
                                                           measure to be taken, as justified by public health
                                                           requirements.
XIX                                           ARTICLE 19(l)(a)
                                         Article l(2)(c) (Directive 93/42/EEC)
"(c) in vitro diagnostic medical device means any           "(c) in vitro diagnostic medical device means any
medical device which is a reagent, reagent product,         medical device which is a reagent, reagent
calibrator, control material, kit, instrument,              product, calibrator, control material, kit,
apparatus, equipment or system whether used alone           instrument, apparatus, equipment or system
or in combination, intended by the manufacturer to be       whether used alone or in combination, intended
used in vitro for the examination of specimens              by the manufacturer to be used in vitro for the
including blood and tissue donations, derived from          examination of specimens including blood and
the human body, solely or principally for the purpose       tissue donations, derived from the human body,
of providing information concerning a physiological         solely or principally for the purpose of providing
state, state of health or disease or congenital             information concerning a physiological state,
abnormality or to determine the safety and                  pathological state or congenital abnormality or to
compatibility with potential recipients".                   determine the safety and compatibility with
                                                            potential recipients".
 ---pagebreak---                                                    - 10-
                   INITIALTEXT                                              MODIFIED TEXT
XX.                                             ARTICLE 19(l)(ab)(new)
                                                Article 1(2) (ia) (new) (Directive 93/42/EEC0
                                                           (ab). In article 1(2), the following point (ia) shall be
                                                           added :
                                                           "(ia) authorized representative means the natural or
                                                           legal person as established within the Community
                                                           who, being explicitly 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".
XXI.                                            ARTICLE 19(l)(b)
                                                Article l(5)(f) (Directive 93/42/EEC)
"(f) transplants or tissues or cells of human origin,       "(f) transplants or tissues or cells of human
unless a device is manufactured utilizing tissues or        origin, unless a medical device is manufactured
substances derived from such tissues which are non          utilizing cells or tissue of human origin having
viable or rendered non viable. In this case, the            undergone a process of transformation which
directive shall not affect national regulations relating    removes the cellular organization or the
to the ethics of the collection of tissues or substances    characteristic structure of the tissue of origin
of human origin, as well as any regulations relating        and renders such material non viable. In this
to the ethics governing distribution of given types of      case, the directive shall not affect national
devices of such origin."                                    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. "
XXII.                                           ARTICLE 19(l)(ba)(new)
                                                Article 2 (Directive 93/42/EEC)
                                                             (ba) Article 2 shall read as follows :
                                                                                   "Article 2
                                                             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 supplied, installed,
                                                             maintained and used in accordnace with their
                                                             intended purpose."
 ---pagebreak---                                                   -11
                    INITIAL TEXT                                          MODIFIED TEXT
XXIII.                                         ARTICLE 19(l)(c)
                         Annex 1(8.2), 1st subparagraph (Directive 93/42/EEC)
"8.2. Where a device is manufactured utilizing           "8.2. Where a medical device is manufactured
human tissues or substances derived from human           utilizing human tissues or cells or substances
tissues, the use of such tissues or substances must be   derived from human tissues, as described in
subject to the relevant validated selection and          Article l(5Xf) above, the use thereof must be
screening procedures, including traceability as          subject to the relevant validated selection and
appropriate in relation to the inherent risk.            screening procedures, including traceability as
                                                          appropriate in relation to the inherent risk."
XXIV.                                          ARTICLE 19(l)(d)
                              Annex I (13.3) (n) (Directive 93/42/EEC)
n) in the case of devices incorporating tissues of         "n) in the case of medical devices which,
human origin or substances derived from such tissues, during manufacture, utilize cells or tissues of
a statement indicating that the device incorporates        human origin or substances derived from such
tissue or substances derived from tissue of human          tissues, a statement indicating that the medical
origin as appropriate                                      device contains substances of human origin;"
 XXV.                                          ARTICLE 19(l)(e)
             Annex II (3.2) (c) and Annex III (3), third last indent (Directive 93/42/EEC)
 - in the case of devices incorporating tissues of human    "- in the case of medical devices manufactured
 or animal origin, information on the selection and         using substances derived from cells or tissues
 origin;                                                    of human or animal origin, information on the
                                                            selection and origin;"
 XXVI.                                         ARTICLE 19 (l)(f)
                      Annex IX (III) (4.5), last subparagraph (Directive 93/42/EEC)
 All devices manufactured utilizing human tissues or         "All medical devices which during their
 substances derived from such tissues are in class III.      manufacture utilize cells or tissues of human
                                                             origin or substances produced therefrom are in
                                                             class in."
 ---pagebreak---                                                    -12
                   INITIAL TEXT                                          MODIFIED TEXT
XXVII.                                         ANNEX 1(1)
1. The devices must be designed and manufactured        1. The devices must be designed^ manufactured
in such a way that, when used under the conditions      and packaged in such a way that, when used under
and for the purposes intended, they will not            the conditions and for the purposes intended, they
compromise, directly or indirectly, the clinical        will not compromise, directly or indirectly, the
condition or the safety of the patients, the safety and clinical condition or the safety of the patients, the
health of users and, where applicable, other persons,   safety and health of users and, where applicable,
and the safety of property. Any risks, which may be     other persons, and the safety of property. Any
associated with their use, must be acceptable when      risks, which may be associated with their use,
weighed against the benefits to the patient and are     must be acceptable when weighed against the
compatible with a high level of protection of health    benefits to the patient and are compatible with a
and safety.                                             high level of protection of health and safety
XXVIII.                                         ANNEX 1(2), 2nd subparagraph, 1st indent
- eliminate or reduce risks as far as possible            - eliminate or reduce risks as far as possible
(inherently safe design and construction)                 (inherently safe design, construction, and
                                                          packaging)
XXIX.                                           ANNEX 1 (6.1) and (6.2)
6.1. The devices must be designed and manufactured         6.1. The devices must be designed^ manufactured
in such a way as to achieve the characteristics and        and packaged in such a way as to achieve the
performances referred to in Section I on the "General      characteristics and performances referred to in
Requirements". Attention must be paid to the               Section I on the "General Requirements".
possibility of impairment of analytical performance        Attention must be paid to the possibility of
due to incompatibility between the materials used and      impairment of analytical performance due to
the samples (such as biological tissues, cells, body       incompatibility between the materials used and the
 fluids and micro-organisms) intended to be used with      samples (such as biological tissues, cells, body
the device, taking account of its intended purpose.        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        6.2. The devices must be designed, manufactured
packed in such a way as to reduce as far as possible       and packed in such a way as to reduce to the
the risk posed by leakage products, contaminants and       minimum the risk posed by product leakage,
residues to the persons involved in the transport,         contaminants and residues to the persons involved
 storage and use of the devices, taking account of the     in the transport, storage and use of the devices,
 intended purpose of the products.                         taking account of the intended purpose of the
                                                           products.
 ---pagebreak---                                                      13
                     INITIAL TEXT                                            MODIFIED TEXT
XXX.                                             ANNEX 1(7.1)
7.1. The devices must be designed in such a way as         7.1. The devices must be designed in such a
to eliminate or reduce as far as possible the risk of       way as to eliminate or reduce to the minimum
infection to the user or other persons. The design          all risk of infection to the user or other persons.
must allow easy handling and, where necessary,              The design must allow easy handling and,
reduce as far as possible contamination of and              where necessary, reduce as far as possible
leakage from the device during use and, in the case         contamination of and leakage from the device
of specimen receptacles, the risk of contamination          during use and, in the case of specimen
of the specimen. The manufacturing processes must           receptacles, the risk of contamination of the
be appropriate for these purposes                           specimen. The manufacturing processes must
                                                            be appropriate for these purposes
XXXI.                                            ANNEX 1 (7.2)
7.2. Where a device incorporates biological                  7.2. Where a device incorporates biological
 substances, the risks of infection must be reduced as       substances, all risk of infection to the user or
far as possible by selecting appropriate donors,             other persons must be eliminated or reduced to
 appropriate substances and using appropriate                the minimum by selecting appropriate donors,
 inactivation, conservation, test and control                appropriate substances and using appropriate
procedures.                                                  inactivation, conservation, test and control
                                                             procedures.
 XXXII.                                          ANNEX 1 (7.5)
 7.5. Packaging systems for devices other than those           7.5. Packaging systems for devices other
 referred to in section 7.3 must keep the product              than those referred to in section 7.3 must keep
 without deterioration at the level of cleanliness, if any,    the product without deterioration at the level of
 as indicated by the manufacturer and, if the devices          cleanliness, if any, as indicated by the
 are to be sterilized prior to use, reduce as far as           manufacturer and, if the devices are to be
 possible the risk of microbial contamination.                 sterilized prior to use, reduce to the minimum
                                                               the risk of microbial contamination.
 Steps shall be taken to reduce microbial                      Step» shall be taken to reduce as far as possible
 contamination during selection and handling of raw            microbial contamination during selection and
 materials, manufacture, storage and distribution where        handling of raw materials, manufacture, storage
 the performance of the device can be adversely                and distribution where the performance of the
 affected by such contamination.                               device can be adversely affected by such
                                                               contamination.
 ---pagebreak---                                                     14-
                   INITIALTEXT                                         MODIFIED TEXT
XXXIII.                                        ANNEX 1 (8.3) and (8.4)
8.3. Devices must be designed and manufactured in        8.3. Devices must be designed^ manufactured
such a way as to reduce as far as possible the risks of  and packaged in such a way as to reduce as far
fire or explosion during normal use. Particular          as possible the risks of fire or explosion during
attention must be paid to devices whose intended use     normal use. Particular attention must be paid to
includes exposure to or use in association with          devices whose intended use includes exposure
flammable substances or substances which could cause     to or use in association with flammable
combustion.                                              substances or substances which could cause
                                                         combustion.
8.4. Devices must be designed and manufactured in        8.4. Devices must be designed., manufactured
such a way as to facilitate the management of safe       and packaged in such a way as to facilitate the
waste disposal.                                          management of safe waste disposal.
XXXIV.                                         ANNEX 1 (12), introduction and (1)
Devices for self-testing must be designed and              Devices for self-testing must be designed.,
manufactured in such a way that they perform               manufactured and packaged in such a way that
appropriately for their intended purpose taking into       they perform appropriately for their intended
account the skills and the means available to users and    purpose taking into account the skills and the
the influence resulting from variation that can            means available to users and the influence
reasonably be anticipated in users' technique and          resulting from variation that can reasonably be
environment. The information and instructions provided     anticipated in users' technique and
by the manufacturer should be easily understood and        environment. The information and instructions
applied by the user.                                       provided by the manufacturer should be easily
                                                           understood and applied by the user.
 12.1 Devices for self-testing must be designed and        12.1 Devices for self-testing must be designed.,
manufactured in such a way as to reduce as far as          manufactured and packaged in such a way as to
practicable the risk of user's error in handling and in    reduce as far as practicable the risk of user's
interpretation of the result.                              error in handling and in interpretation of the
                                                           result.
 ---pagebreak---                                                    -15-
                   INITLALTEXT                                           MODIFIED TEXT
XXXIV.                                          ANNEX 2(2)
2. Reagents and reagent products for the detection in         2. Reagents and reagent products for the
human specimens of markers of HIV infection, Hepatitis        detection in human specimens of markers of
B and C;                                                      HIV infection, Hepatits B and C. Rubella and
                                                              toxoplasmosis.
XXXVI.                                          ANNEX 7 (3.2), 3rd subparagraph (d)
(d) the appropriate tests and trials to be carried out  (d) the appropriate tests and trials to be carried out
before, during and after manufacture, the frequency     before, during and after manufacture, the
with which they will take place, and the test           frequency with which they will take place, and the
equipment used; it must be possible adequately to       equipment used; the calibration of this equipment
trace back the calibration of the test equipment.       must be such as to guarantee adequate traceability.
 ---pagebreak---  ---pagebreak---                                               /It-
                                                                  ISSN 0254-1475
                                                           COM(96) 643 final
                                             DOCUMENTS
EN                                                                       15 05
                                    Catalogue number : CB-C0-96-641-EN-C
                                                             ISBN 92-78-13009-5
Office for Official Publications of the European Communities
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