In Vitro Diagnostic Medical Devices

United Kingdom · Last verified: 2026-09-08

Number

S.I. 2002/618 PART IV

Type

Regulation

Issuer

Secretary of State (UK); administered by MHRA

Status

in_force

Authority

MHRA

What this covers

第四部分规范体外诊断医疗器械（原 98/79/EC 转化）的基本要求、清单分类、合格评定、自测器械与性能评价器械的要求。

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