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) 

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 
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. 
INITIAL TEXT MODIFIED TEXT 
I. Recital 3 
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 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, in the best 
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 
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; Whereas in vitro diagnostic medical devices 
should provide patients, users and third parties 
with a high level of health protection and attain 
the performance levels originally attributed to 
them by the manufacturer; whereas, therefore, the 
maintenance or improvement of the level of 
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 
the Council resolution of 7 May 1985 concerning a 
new approach to technical 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, in accordance with the principles set out 
in the Council resolution of 7 May 1985 
concerning a new approach to technical 
harmonization and standardization, rules 
regarding the design, manufacture and packaging 
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 
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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 
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 taking in line with the 
procedure Ilia as laid down in Council Decision 
87/373/EEC; 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 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 taking in line with the 
procedure Ilia as laid down in Council Decision 
87/373/EEC; whereas an agreement on a "modus 
vivendi" between the European Parliament, the 
Council and the Commission concerning the 
implementation measures of the acts adopted 
pursuant to the procedure referred to in Article 
189b of the EC Treaty took place on 20 
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 
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INITIALTEXT MODIFIED TEXT 
VI. Recital 18 
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 Sates are necessary in 
view of uniform application of this Directive, in 
particular for the purpose of market surveillance; 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, in order to take any protection 
measures that should prove necessary; whereas 
cooperation and exchange of information between 
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 
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. 1. This Directive shall apply to in vitro diagnostic 
medical devices, including therapy monitoring 
devices for diagnostic purpose , 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, 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 
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; 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, 
pathological state or congenital abnormality or to 
determine the safety and compatibility with 
potential recipients. 
For the purpose of this directive, a specimen 
receptacle, whether a vacuum-type 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; 
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INITIAL TEXT MODIFIED TEXT 
IX. ARTICLE l(2)(e) 
(e) "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; (e) "Device for performance evaluation" means 
any device intended by the manufacturer to be 
subject to one or more performance evaluation 
studies in laboratories for medical analysis or in 
other appropriate environments outside his own 
premises; 
X. 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 installed, 
maintained and used in accordance with their intended 
purpose. 1. 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 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, 
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. 2. At trade fairs, exhibitions, demonstrations or 
scientific and technical meetings. 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. 
8-
INTTIALTEXT MODIFIED TEXT 
XIII. 
Registration of manufacturers ARTICLE 10, title 
Registration of manufacturers and devices 
XIV. ARTICLE 11(3) 
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. 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, including possible 
withdrawal, have been taken or are contemplated. 
XV. ARTICLE 11(4), introduction 
4. Where, in the context of notification referred to in 
Article 10, 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: 4. Where, in the context of notification referred to 
in Article 10, 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 gained with the 
device subsequent to its being placed on the 
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. 
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INITIALTEXT MODIFIED TEXT 
XVII. ARTICLE 13(2) 
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. 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 criteria applicable in accordance with the said 
Annex 9. 
XVIII. ARTICLE 16(2) 
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. 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, 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 
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". "(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, 
pathological state or congenital abnormality or to 
determine the safety and compatibility with 
potential recipients". 
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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." 
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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 
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. "8.2. Where a medical device is manufactured 
utilizing human tissues or cells or substances 
derived from human tissues, as described in 
Article l(5Xf) above, the use thereof must be 
subject to the relevant validated selection and 
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 
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 "n) in the case of medical devices which, 
during manufacture, utilize cells or tissues of 
human origin or substances derived from such 
tissues, a statement indicating that the medical 
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 
or animal origin, information on the selection and 
origin; "- in the case of medical devices manufactured 
using substances derived from cells or tissues 
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 
substances derived from such tissues are in class III. "All medical devices which during their 
manufacture utilize cells or tissues of human 
origin or substances produced therefrom are in 
class in." 
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INITIAL TEXT MODIFIED TEXT 
XXVII. ANNEX 1(1) 
1. 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, 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. 1. The devices must be designed^ manufactured 
and packaged 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, 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 
XXVIII. 
- eliminate or reduce risks as far as possible 
(inherently safe design and construction) ANNEX 1(2), 2nd subparagraph, 1st indent 
- eliminate or reduce risks as far as possible 
(inherently safe design, construction, and 
packaging) 
XXIX. ANNEX 1 (6.1) and (6.2) 
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 incompatibility between 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. 6.1. The devices must be designed^ manufactured 
and packaged 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 
incompatibility between 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 to the 
minimum the risk posed by product leakage, 
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. 
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INITIAL TEXT MODIFIED TEXT 
XXX. ANNEX 1(7.1) 
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 7.1. The devices must be designed in such a 
way as to eliminate or reduce to the minimum 
all 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 
XXXI. ANNEX 1 (7.2) 
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 
inactivation, conservation, test and control 
procedures. 7.2. Where a device incorporates biological 
substances, all risk of infection to the user or 
other persons must be eliminated or reduced to 
the minimum by selecting appropriate donors, 
appropriate substances and using appropriate 
inactivation, conservation, test and control 
procedures. 
XXXII. ANNEX 1 (7.5) 
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. 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 to the minimum 
the risk of microbial contamination. 
Step» shall be taken to reduce as far as possible 
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. 
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INITIALTEXT MODIFIED TEXT 
XXXIII. ANNEX 1 (8.3) and (8.4) 
8.3. 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 be paid to devices whose intended use 
includes exposure to or use in association with 
flammable substances or substances which could cause 
combustion. 8.3. Devices must be designed^ manufactured 
and packaged in such a way as to reduce as far 
as possible the risks of fire or explosion during 
normal use. Particular attention must be paid to 
devices whose intended use includes exposure 
to or use in association with flammable 
substances or substances which could cause 
combustion. 
8.4. Devices must be designed and manufactured in 
such a way as to facilitate the management of safe 
waste disposal. 8.4. Devices must be designed., manufactured 
and packaged in such a way as to facilitate the 
management of safe waste disposal. 
XXXIV. ANNEX 1 (12), introduction and (1) 
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. Devices for self-testing must be designed., 
manufactured and packaged 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., 
manufactured and packaged 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. 
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INITLALTEXT MODIFIED TEXT 
XXXIV. ANNEX 2(2) 
2. Reagents and reagent products for the detection in 
human specimens of markers of HIV infection, Hepatitis 
B and C; 2. Reagents and reagent products for the 
detection in human specimens of markers of 
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 
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. (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 
equipment used; the calibration of this equipment 
must be such as to guarantee adequate traceability. 

/It-
ISSN 0254-1475 
COM(96) 643 final 
DOCUMENTS 
EN 15 05 
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ISBN 92-78-13009-5 
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