Amended proposal for a EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE AMENDING THE DIRECTIVE PROPOSAL ON IN VITRO DIAGNOSTIC MEDICAL DEVICES
Date: 1996-12-20
Institutions: European Commission
Subjects: harmonisation of standards, marketing, medical device, product safety, trade information

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 

THE DIRECTIVE PROPOSAL ON IN VITRO DIAGNOSTIC  MEDICAL  DEVICES 

AMENDING 

(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: 

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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: 

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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 
Amendment 4, which supports retention of the Commission proposal, has been  preferred; 

to  Directive 89/392/EEC 

to  machinery 

(amendment 40). 

relating 

certain  technical  points  (amendments 20, 43 and 54).  No amendments  are needed  on these 
points. 

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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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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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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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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 

XII. 

ARTICLE 3a (new) 

This Directive shall not affect  national laws 
which provide for the supply of diagnostic 
medical devices by a medical prescription. 

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. 

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XIII. 

ARTICLE 10, title 

Registration of  manufacturers 

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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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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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, 
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." 

"(f) transplants or tissues or cells of human 
origin, unless a medical device is manufactured 
utilizing cells or tissue of human origin having 
undergone a process of transformation  which 
removes the cellular organization or the 
characteristic structure of the tissue of origin 
and renders such material 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. " 

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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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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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. 

ANNEX 1(2), 2nd subparagraph, 1st indent 

- eliminate or reduce risks as far as possible 
(inherently safe design and construction) 

- 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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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) 

Packaging systems for devices other than those 

7.5. 
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. 

Packaging systems for devices other 

7.5. 
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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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. 

- 1 5-

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 

Catalogue number  :  CB-C0-96-641-EN-C 

ISBN 92-78-13009-5 

Office  for Official  Publications of the European Communities 

L-2985 Luxembourg