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现行欧盟医疗器械指令及与新法规对比浅谈 被引量：2

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。 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.
作者 付强
机构地区 上海理工大学
出处 《中国医疗器械杂志》 2016年第3期202-206,共5页 Chinese Journal of Medical Instrumentation
关键词 欧盟 医疗器械 指令 法规 European Union medical device directive regulation
分类号 D95 [政治法律—法学] DD912.29 [政治法律]
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参考文献9

  • 1刘波.欧盟最新医疗器械法规要点浅析[J].中国医疗器械信息,2013,19(9):37-38. 被引量：2
  • 2International Organization for Standardization.Biological evaluation of medicaldevices-Part1:Evaluation and testing within a risk management process. ISO10993-1 . 2009
  • 3Council Directiveof 90/385/EEC 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices. http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01990L0385-20071011 .
  • 4Council Directive 93/42/EEC of 14 June 1993 concerning Medical Devices. http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01993L0042-20071011 .
  • 5MEDICAL DEVICES:Guidance document-Classification of medical devices June 2010. http://ec.europa.eu/growth/sectors/medical-devices/guidance/index_en.htm .
  • 6GHTF/SG1/N40:2006(R/OL)http://www.imdrf.org/docs/ghtf/final/sg1/technical-docs/ghtf-sg1-n40-2006-guidance-ca-principles-060626.pdf#search='GHTF SG1 N40 65306;2006' .
  • 7Proposal for a regulation of the European parliament and of the council 12040/1/15 REV 1. http://data.consilium.europa.eu/doc/document/ST-12040-2015-REV-1/en/pdf .
  • 8Proposal for a regulation of the European parliament and of the council 12040/15 ADD 1. http://data.consilium.europa.eu/doc/document/ST-12040-2015-ADD-1/en/pdf .
  • 9GHTF/SGl INOll:2008(R/OL)http://www.imdrf.org/docs/ghtf/final/sg1/technical-docs/ghtf-sg1-n011-2008-principles-safetyperformance-medical-devices-080221.pdf#search='ghtf sg1 no11' .

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中国医疗器械杂志
2016年 第3期

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