现行欧盟医疗器械指令及与新法规对比浅谈

摘要

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.%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。