Directive - 93/42 - EN - medical device directive - EUR-Lex
COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European …
2017/745 - EN - Medical Device Regulation - EUR-Lex
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and …
Medical Devices Directive - Wikipedia
The Medical Device Directive — Council Directive 93/42/EEC of 14 June 1993 concerning medical devices —is intended to harmonise the laws relating to medical devices within the …
Medical devices - European Medicines Agency (EMA)
Medical devices are products or equipment intended for a medical purpose. In the European Union (EU) they must undergo a conformity assessment to demonstrate they meet legal …
2007年10月11日 · European databank 1. Regulatory data in accordance with this Directive shall be stored in a European database accessible to the competent authorities to enable them to …
医疗器械新法规MDR和MDD指令有什么区别？ - 知乎
2017年5月5日，欧盟官方期刊（Official Journal of the European Union）正式发布了欧盟医疗器械法规（REGULATION (EU) 2017/745，简称“MDR”）。 MDR将取代Directives 90/385/EEC （ …
New Regulations - European Commission - Public Health
With effect from 26 May 2021, Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices replaced Council Directive 90/385/EEC on active …
Medical devices - European Commission - Internal Market, …
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and …
Directives - European Commission - Public Health
The European Commission has adopted several implementing measures based on the medical devices directives. These measures concern, among other things, medical devices …
MDR与MDD有什么区别？ - 知乎
2017年5月5日，欧盟官方期刊（Official Journal of the European Union）正式发布了欧盟医疗器械法规（REGULATION (EU) 2017/745，简称“MDR”）。 MDR将取代Directives 90/385/EEC （ …
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