现行欧盟医疗器械指令及与新法规对比浅谈
Current Medical Device Directive in EU and Brief Comparison with the New Regulation
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摘要: 该文主要介绍了现行欧盟医疗器械指令MDD(93/42/EEC),并与提案中的欧盟医疗器械新法规做了简要对比。Abstract: This paper describes current European Union(EU) Medical Device Directive(MDD), which is 93/42/EEC, it also briefly compares with proposal for a new regulation.