Best practice guidance on the information required for personnel involved in conformity assessment

European Union · Last verified: 2026-09-08

Number
NBOG BPG 2017-2
Type
Guidance
Issuer
European Commission, DG Health and Food Safety
Status
in_force
Authority
欧盟委员会 / MDCG

What this covers

欧盟委员会器械领域指导文件,属「Notified bodies」专题,委员会指南清单页标注的发布时间为 February 2018;内容为「Best practice guidance on the information required for personnel involved in conformity assessment」。此类文件无强制法律效力,但代表成员国主管当局与公告机构对 MDR/IVDR 的共同解释口径。注意 effective 填的是发布月份(日补 01),不是法律生效日。

Official text: https://health.ec.europa.eu/document/download/9208332f-7b02-43c7-99d8-193d705a

© European Union, source: EUR-Lex / European Commission. Changes made by this site: {changes}

Facts only; not legal advice. The official current text prevails.