200747EC新指令VIP专享VIP免费

DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCILof 5 September 2007amending Council Directive 90/385/EEC on the approximation of the laws of the Member Statesrelating to active implantable medical devices, Council Directive 93/42/EEC concerning medicaldevices and Directive 98/8/EC concerning the placing of biocidal products on the market(Text with EEA relevance)THEEUROPEANPARLIAMENTANDTHECOUNCILOFTHEEUROPEAN UNION,Having regard to the Treaty establishing the European Commu-nity, and in particular Article 95 thereof,Having regard to the proposal from the Commission,Having regard to the opinion of the European Economic andSocial Committee (1),Acting in accordance with the procedure laid down in Article 251of the Treaty (2),Whereas:(1)Council Directive 93/42/EEC (3) requires the Commissionto submit a report to the Council, no later than five yearsfrom the date of implementation of that Directive,concerning: (i) information on incidents occurring follow-ing the placing of devices on the market, (ii) clinicalinvestigation carried out in accordance with the procedureset out in Annex VIII to Directive 93/42/EEC, and (iii)design examination and EC type examination of medicaldevices that incorporate, as an integral part, a substancewhich, if used separately, may be considered to be amedicinal product as defined in Directive 2001/83/EC ofthe European Parliament and of the Council of 6 November2001 on the Community code relating to medicinalproducts for human use (4) and which is liable to act uponthe body with action ancillary to that of the device.(2)The Commission brought forward the conclusions of thatreport in its Communication to the Council and theEuropean Parliament on medical devices which, at therequest of th...