Post-market surveillance requirements

United Kingdom · Last verified: 2026-09-08

Number

S.I. 2002/618 PART 4A

Type

Regulation

Issuer

Secretary of State (UK); administered by MHRA

Status

in_force

Authority

MHRA

What this covers

第 4A 部分是 2024 年新增、2025 年 6 月 17 日起施行的上市后监督（PMS）要求，规定制造商的 PMS 体系、PMS 计划与报告、趋势报告、事故与现场安全纠正措施的报告义务及适用范围。

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