Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance)

European Union · Last verified: 2026-09-08

Number

32017R0746

Type

Act

Issuer

European Parliament and Council of the European Union

Status

in_force

Authority

欧盟委员会 / MDCG

What this covers

欧盟体外诊断试剂主法规 IVDR，取代 98/79/EC 指令，引入基于风险的 A/B/C/D 四级分类，绝大多数 IVD 由自我声明转为必须有公告机构介入。

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