COMMISSION OF THE EUROPEAN COMMUNITIES 
Brussels, 02.10.1998 
COM(1998) 548 final 
95/0013 (COD) 
OPLNION OF THE COMMISSION 
pursuant to Article 189 b (2) (d) of the EC Treaty, 
on the European Parliament's amendments 
to the Council's common position regarding the 
proposal for a 
EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE 
on in vitro diagnostic medical devices 
AMENDING THE PROPOSAL OF THE COMMISSION 
pursuant to Article 189 a (2) of the EC Treaty 

1. BACKGROUND 
a) Objective of the proposal 
The proposal for a directive, based on Article 100a of the Treaty, is intended to 
harmonise national provisions applicable to the placing on the market of in vitro 
diagnostic medical devices. It lays down the requirements to be met by the 
products with regard to protecting the health and safety of patients, users and third 
parties; the conditions governing their placing on the market and aspects 
concerning checks on products already on the market. Article 21 also provides for 
a number of amendments to Directive 93/42/EEC on medical devices, to include 
devices manufactured using human tissues in the scope of Directive 93/42/EEC, 
and to bring Directive 93/42/EEC more closely into line with the Directive on in 
vitro diagnostic devices. 
b) Date of the submission of the proposal to the Council (document COM(95)130 
final-95/0013 (COD)): 19 April 1995 
c) Opinion of the Economic and Social Committee: 25 October 1995 
d) Date of the European Parliament's opinion on first reading: 14 March 1996 
e) Date of the adoption of the common position : 23 March 1996 
f) Date of the presentation of an amended Commission proposal (document 
COM(96)643 final): 20 December 1996 
g) Commission communication to the European Parliament pursuant to Article 
189b(2) (document SEC(1998) 555 final): 26 March 1998 
h) Date of the European Parliament's decision on second reading: 18 June 1998 
2. POSITION OF THE EUROPEAN PARLIAMENT 
At its plenary session in June 1998, the European Parliament adopted 6 amendments to 
the Council common position. These are intended to: 
emphasise the need to notify the competent authorities of the placing on the 
market of new products, such as DNA micro-chips (amendment 1, Recital 29a) 
insist on the need for Community legislation on medical devices manufactured 
using human tissues or cells (amendment 2, Recital 33a); 
clarify that the option for Member States to demand supplementary information 
for certain medical devices is not a precondition for the placing on the market or 
putting into service of in vitro diagnostic medical devices (amendment 3, Article 
10(2), second subparagraph); 
2^ 
oblige manufacturers to translate the label and the instructions for use of the self-
testing devices into one or more of the languages of the Member State where the 
in vitro diagnostic medicd device reaches its final user (amendment 4, Annex I, 
(B)(8. J), fifth paragraph a); 
oblige manufacturers to submit the tests used for evaluating the risk of trisomy 21 
(Down's Syndrome in the foetus) to certification by a third party (amendment 5, 
Annex II, List B, seventh indent a); 
emphasise, with regard to diagnosis, the primary importance of protecting the 
confidentiality of the information obtained and the principle of non-discrimination 
on the basis of the genetic characteristics of the person being examined 
(amendment 6, Article 1(4)). 
3. OPINION OF THE COMMISSION 
The Commission is able to accept the amendments: 
amendment 1 because the new recital relates to the notification procedure for 
"new products" provided for under Article 10(4), and gives an important example 
of the application of that Article; 
amendment 2 because the recital recalls the need, recognised by the Member 
States, for harmonised legislation on medical devices manufactured from 
.substances of human origin. In addition to the essential pari on m vitro diagnostic 
medical devices, the Commission proposal (COM(95) 130 final) provided for the 
inclusion of devices incorporating substance:-; of human origin in the scope of 
Directive 93/42/EEC on medical devices. This pari was separated from thai 
relating to in vitro diagnostic devices and is still before the Council for a first 
reading; 
amendment 3 because it clarifies the interpretation that should be gwen to the 
procedure according to which Member Stales may request information regarding 
the labelling and the instructions for ust- of certain products. The addition is 
useful, as it prohibits supplementary national procedures other than those 
provided for in the Directive on the placing on the market of in vitro diagnostic 
medical devices. 
amendment 4 because it adds a useful clarification with regard to the extent of the 
labelling obligations for self-testing devices, in accordance with the principle 
already included in Article 4(4); 
amendment 5 because the extension of certification obligations by a third part) to 
tests designed to assess the risk of trisomy 2i (Downs Syndrome) in the foetus is 
justified, as it is necessary to ensure a very high level of quality ol'devices as false 
positive results from the tests have serious consequences for the patient and (he 
foetus; 
2> 
amendment 6 because it restates the rights set out in the European Convention for 
the Protection of Human Rights and Fundamental Freedoms with regard to the 
applications of biology and medicine referred to in Article I (4). 
For these reasons, and pursuant to Article 189a of the EC Treaty, the Commission has 
decided to amend its proposal to incorporate the 6 amendments adopted by the European 
Parliament. 
^ 
Amended proposal for a 
European Parliament and Council Directive 
on in vitro diagnostic medical devices 
(presented by the Commission pursuant to Article 189a(2) of the EC Treaty) 
Common position of the 
Council Modified proposal 
Recital 29a (new) 
{29a) Whereas il is essential_that 
manufacturers notify the 
conjgejgm authorities of the 
placing on the market of View 
products' with regard both to the 
technology used and the 
substances to he analysed or other 
parameters; this is true in 
particular of high-density DNA 
probe devices (known as micro-
ghiosjused In^gejieiicjiCjggnmg, 
Recital 33a (new) 
For the purposes of this 
Directive, the removal, 
collection and use of tissues, 
ceiis and substances of 
human origin shall be 
governed, in relation to 
ethics, by the principles Said 
down in the Convention of 
the Council of Europe for the 
protection of human rights 
and dignity of the human 
being with regard to the 
application of biology and 
medicine and by any Member 
States' regulations on this 
matter. Article 1(4; (33a) Whereas it is necessary to 
draw up as quickly as possible 
the legislation which is lacking 
on medical devices manufactured 
using substances of. human 
origin; 
For the purposes of this 
Directive, the removal, collection 
and use of tissues, cells and 
substances of human origin shall 
be governed, in relation to ethics, 
by the principles laid down in the 
Convention of the Council of 
Europe for the protection of 
human rights and dignity oï the 
human being with regard to the 
application of biology and 
medicine and by any Member 
States" regulations on this matte.»". 
•M mm^^k^É^s*!^^^ 
.?l_Jiie_ j:pnfLd?ji tïaiity__. of. __ data 
principle of non-discrimination Common position of the 
Council Modified-proposal 
Recital 29a (new) 
{29a) Whereas it is essentiai_that 
manufacturers notify the 
conjgejgm authorities of the 
placing on the market of 'new 
•products' with regard both to the 
technology used and the 
substances to be analysed or other 
parameters; this is true in 
particular of high-density DNA 
probe devices (known as micro-
ghiosjused in^gejieiiçjiCjgejùng, 
Recital 33a (new) 
For the purposes of this 
Directive, the removal, 
collection and use of tissues, 
ceiis and substances of 
human origin shall be 
governed, m relation to 
ethics, by the principles Said 
down in the Convention, of 
the Council of Europe for the 
protection of human rights 
and dignity of the human 
being with regard to the 
application of biology and 
medicine and by any Member 
States' regulations on this 
matter. Article 1(4; (33a) Whereas it is necessary to 
draw up as quickly as possible 
the legislation which is lacking 
on medical devices manufactured 
using substances of. human 
origin; 
For the purposes of this 
Directive, the removal, collection 
and use of tissues, cells and 
substances of human origin shall 
be governed, in relation tc ethics, 
by the principles laid down in the 
Convention of the Council of 
Europe for the protection of 
human rights and dignity o\ the 
human being with regard to the 
application of biology and 
medicine and by any Member 
States' regulations on this matte.»". 
•M mm^^k^É^s*!^^^ 
.?l_Jiie_ j:pnfLd?ji tïaiity__. of _ data 
^Mits.„i2_jiàyyte...JitçLJAiî4...:^ 
principle of non-discrimination 
Article 10(2), second 
subparagraph (new) 
Annex l,(B)(8.l), 
5lh subparagraph a 
(new) 
Annex II, List B, 
7th indent a (new) on grounds of human inherited 
genetic characteristics shall be 
paramount. 
These measures cannot constitute 
a precondition for the placing on 
the market and/or putting into 
service of devices which are in 
conformity with this Directive. 
The decision whether to translate 
the instructions for use and the 
label into one or more languages 
of the European Union shall be 
left to the Member States, except 
that, for self-testing devices, the 
instructions for use and the label 
shall include a translation into the 
official language(s) of the 
Member State in which the 
device for self-testing reaches its 
final user. 
Reagents and reagent products, 
including related calibrators, 
control materials and software, 
designed specifically for 
evaluating the risk of trisomy 21. 

ISSN 0254-1475 
COM(98) 548 final 
DOCUMENTS 
EN 15 05 16 01 
Catalogue number : CB-CO-98-550-EN-C 
ISBN 92-78-39453-X 
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