COMMISSION OF THE EUROPEAN COMMUNITIES 
COM(90) 247 final - SYN 173 
Brussels, 14 june 1990 
Re-examined proposal for a 
COUNCIL DIRECTIVE 
on the approximation of the lavs of the Member States 
relating to aotive implantable medical devices 
COM (88) 717 final SYN 173 
COM (89) 418 
(presented by the Commission pursuant to Article 149.2(d) 
of the EEC treaty) 
Explanatory Memorandum 
The proposal Directive (COM (88) 717 final SYN 173), which is 
based on Article 100 A of the EEC Treaty, was sent to the Council 
on 22 December 1988. 
Parliament delivered its opinion on the proposal at its 
session of 12 April 1989. As a result of this opinion, the 
Commission amended its proposal (see COM (89) 418) to take 
account of the changes suggested by Parliament. 
On 22 February 1990, the Council adopted a common position with a 
view to the adoption of a Directive on the approximation of the 
laws of the Member States relating to active medical devices. 
This Common Position was sent to the Parliament which adopted 4 
amendments at its session of May 1990. 
Pursuant to paragraph (2) d) of Article 149 of EEC Treaty the 
Commission re-examined its proposal and decided to accept 3 of 
the 4 amendments and to refuse one of these amendments for the 
reasons given in annex. 
This re-examined proposal takes into account the amendments which 
the Commission considers as acceptable. 
RE-EXAMINED PROPOSAL £Q£ A CQÏÏNGIL DIRECTIVE 
on the approximation of the laws of the Member States 
relating to active implantable medical devices 
The Commission approves the Common Position of the Council 
countained in document 4071/90 of February 23, 1990, subject to 
the following amendments : 
1. AMENDMENT OF ARTICLE 10 PARAGRAPHS 1 AND 2 
"1. In the case of devices intended for clinical investigations, 
the manufacturer or his authorized representative established in 
the Community shall, at least forty-five days before the 
commencement fo the investigations, submit the statement referred 
to in Annex 6 to the competent authorities of the Member State in 
which the investigations are to be conducted. 
2. The manufacturer may commence the relevant clinical 
investigations at the end of a period of forty-five days after 
notification, unless the competent authorities have notified him 
within that period of a decision to the contrary, based on 
considerations of public health or public order." 
2. ADDITION OF A NEW PARAGRAPH 4 TO THE ARTICLE 11 
"4. The notified body and the manufacturer or his authorized 
representative established within the Community shall agree on 
the time-limits for the completion of the evaluation and 
verification operations referred to in Annexes 2 to 5." 
3. AMENDMENT OF ARTICLE 16, PARAGRAPH 3 
"3. Member States permit for the period up to 31 December 1994, 
the placing on the market and putting into service of devices 
complying with national rules in force in their territory on 31 
December 1992." 
ANNEX 
REMARKS ON THE AMENDMENT 
WHICH WAS NOT ACCEPTED BY THE COMMISSION 
Amendment n° 4 
Annex 6, Point 2.2., introductory phrase 
Common Position of the Council —Text amended by Parliament"-
"2.2. For devices intended for "2.2. For devices intended for 
clinical investigations clinical investigations :" 
covered in Annex 7 :M 
Opinion of the Commission 
The Commission cannot accept this amendement for the following 
reasons : 
This amendment referring to Annex 6 of the Common Position and 
regarding the deletion of the reference to Annex 7 aims according 
to the report of the European Parliament - at eliminating 
small scale clinical investigations from the provisions of Annex 
7 of the Directive. 
The Commission considers that the provisions of Annex 7 and 
particularly those of points 2.2. and 2.3 should remain 
applicable whether the clinical investigations are small or large 
scale. 
ISSN 0254-1475 
COM(90) 247 final 
DOCUMENTS 
EN 05 06 
Catalogue number : CB-CO-90-265-EN-C 
ISBN 92-77-61022-0 
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