COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT pursuant to the second subparagraph of Article 251 (2) of the EC Treaty concerning the common position of the Council on the adoption of a Directive of the European Parliament and of the Council concerning medical devices incorporating stable derivatives of human blood or human plasma amending Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

1. BACKGROUND

- The proposal for a directive was transmitted to the European Parliament and to the Council on 19 April 1995 (Document COM(1995)130 final) [1]. This proposal included both regulatory provisions concerning in vitro medical devices and also provisions amending Directive 93/42/EEC concerning medical devices, for the purpose of introducing medical devices incorporating tissues of human origin.

[1] OJ C 172 of 7.7.1995, p. 21.

- The European Parliament delivered its opinion in a first reading on 12 March 1996 [2].

[2] OJ C 96 of 1.4.1996, p. 31.

- The Economic and Social Committee delivered its opinion on 25 October 1995 [3].

[3] OJ C 18 of 22.1.1996, p. 12.

- In October 1997 the COREPER agreed to adopt the common position on in vitro diagnostic devices and to defer the adoption of the provisions on devices incorporating tissues of human origin. The Directive on in vitro diagnostic medical devices (98/79/CEE) was adopted on 27 October 1998.

- The political agreement was adopted on 13 and 14 December 1999.

- A common position on the provisions relating to medical devices incorporating tissues of human origin was adopted on 29 June 2000.

2. OBJECTIVE OF THE COMMISSION PROPOSAL

The proposal in question, resulting from the COREPER decision of October 1997 and based on Article 95 of the Treaty, seeks to harmonise national provisions governing the placing on the market of medical devices incorporating tissues of human origin. It establishes the requirements to be met by such products in order to safeguard the health and safety of patients, users and third parties, the conditions linked to their placing on the market and aspects relating to the control of products on the market.

During the discussions in the Council it emerged that it would be advisable to restrict the scope of the proposal to devices containing derivatives of human blood and human plasma, and that devices incorporating other derivatives of human tissues should be the subject of a specific directive.

The common position is consequently restricted to amending Directive 93/42/EEC with a view to introducing provisions concerning derivatives of blood and plasma.

3. COMMENTS ON THE COMMON POSITION

3.1 Some brief general remarks on the common position

As explained, the Commission's initial proposal was divided into two parts, resulting respectively in the adoption of the Directive on in vitro diagnostic medical devices and in the amendment of Directive 93/42/EEC concerning medical devices, in order to include derivatives of human blood and human plasma.

3.2 Outcome of the European Parliament's amendments in the first reading

In its first reading the European Parliament delivered an opinion on all the proposals concerning in vitro diagnostic medical devices and medical devices incorporating human tissues.

The proposed amendments concerning in vitro diagnostic medical devices were all incorporated in Directive (98/79/EEC).

With regard to derivatives of human tissues, in view of the restriction of the scope of the common position solely to derivatives of human blood and human plasma, the amendments proposed by Parliament in paragraphs 33 and 36 became irrelevant.

The other amendments of the European Parliament, concerning derivatives of human blood and human plasma, were accepted by the Commission and incorporated by the Council. They concern in particular the following points:

- a supplement to labelling requirements (37),

- an amendment to requirements concerning the declaration of conformity (38),

- the classification of these substances in class III (39).

3.3 New provisions introduced by the Council and the Commission's position

The approach referred to in paragraph 3.1 resulted in certain additions to the initial proposal to take account of the fact that certain procedures in Directive 89/381/EEC can be applied by analogy, in particular special provisions for medicinal products derived from blood.

3.4 Adoption of the common position

There are no other points to be mentioned concerning the adoption of the common position.

4. CONCLUSION

The Commission accepts the constituent parts of the common position. It notes that the latter is in line with the amendments proposed by the European Parliament.

It therefore calls on the two institutions to conclude the legislative procedure as quickly as possible so that the necessary improvement in health protection in the sector concerned can be achieved.

In addition, the Commission will begin preliminary work in order to consider the advisability of submitting a proposal for a directive concerning substances other than those derived from human blood and human plasma.