RE-EXAMINED PROPOSAL FOR A COUNCIL DIRECTIVE ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO ACTIVE IMPLANTABLE MEDICAL DEVICES
Date: 1990-06-14
Institutions: European Commission
Subjects: EC conformity marking, approximation of laws, marketing, medical device, standardisation, standing committee (EU)

COMMISSION OF THE EUROPEAN  COMMUNITIES 

COM(90)  247  f i n al  -  SYN  173 

Brussels,  14  ju ne  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  ( 8 8)  717  f i n al  SYN  173 
COM  ( 8 9)  418 

(presented  by  the  Commission  pursuant  to  A r t i c le  149.2(d) 
of  the  EEC  t r e a t y) 

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 
clinical investigations 
covered in Annex 7 :M 

"2.2. For devices intended for 
clinical investigations :" 

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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