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 Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance)

European Union · Last verified: 2026-09-08

Number

32017R0745

Type

Act

Issuer

European Parliament and Council of the European Union

Status

in_force

Authority

欧盟委员会 / MDCG

What this covers

欧盟医疗器械主法规 MDR，取代 90/385/EEC 与 93/42/EEC 两个旧指令，重建了分类规则、公告机构指定、临床评价、UDI 与上市后监督的完整要求，是器械进入欧盟市场的根本法律依据。

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