Helsinki Procedure for borderline and classification under MDR & IVDR

European Union · Last verified: 2026-09-08

Number

Helsinki Procedure

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「Borderline and Classification」专题，委员会指南清单页标注的发布时间为 September 2021；内容为「Helsinki Procedure for borderline and classification under MDR & IVDR」。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。

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