MDD_93_42VIP专享VIP免费

Pag e 1 o f 46COUNCIL DIRECTIVE 93/42/EECof 14 June 1993concerning medical devicesTHE COUNCIL OF THE EUROPEAN communities,Having regard to the Treaty establishing theEuropean Economic Community, and in particularArticle 100a thereof,Having regard to the proposal from the Commission(1),In co-operation with the European Parliament (2),Having regard to the opinion of the Economic andSocial Committee (3),Whereas measures should be adopted in thecontext of the internal market; whereas the internalmarket is an area without internal frontiers in whichthe free movement of goods, persons, services andcapital is ensured;Whereas the content and scope of the laws,regulations and administrative provisions in force inthe Member States with regard to the safety, healthprotection and performance characteristics ofmedical devices are different; whereas thecertification and inspection procedures for suchdevices differ from one Member State to another;whereas such disparities constitute barriers to tradewithin the Community;Whereas the national provisions for the safety andhealth protection of patients, users and, whereappropriate, other persons, with regard to the use ofmedical devices should be harmonized in order toguarantee the free movement of such deviceswithin the internal market;Whereas the harmonized provisions must bedistinguished from the measures adopted by theMember States to manage the funding of publichealth and sickness insurance schemes relatingdirectly or indirectly to such devices; whereas,therefore, the provisions do not affect the ability ofthe Member States to implement the abovementioned measures provided Community law iscomplied with;Whereas medical devices should provide patients,users and third parties with a high level of prot...