MHRA
英國藥品和醫療產品監管局
United Kingdom
Last reviewed 2026-06-21
脫歐後，MHRA在英國運營獨立的醫療器材監管框架。英國合格評定（UKCA）標誌正在取代CE標誌。MHRA正在開發與EU MDR不同的獨立器材法規框架。
器材分類
Class I, IIa, IIb, III
審批路徑
UKCA marking via UK Approved Body
核心監管職能
- ▸UKCA標誌
- ▸英國器材註冊
- ▸Yellow Card不良事件報告
- ▸英國批准機構監管
官方網站
https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency →§ FAQ
What is UKCA marking for medical devices?
UKCA (UK Conformity Assessed) marking is the United Kingdom's post-Brexit replacement for CE marking. Medical devices placed on the UK market will need UKCA marking assessed by a UK Approved Body. The UK has extended CE marking recognition deadlines while its own framework is finalized. UKCA requirements are broadly aligned with EU MDR but have UK-specific adaptations.
What is the MHRA Yellow Card scheme?
The Yellow Card scheme is the UK's system for reporting adverse incidents involving medical devices, medicines, and other healthcare products. Healthcare professionals, patients, and manufacturers can submit reports through the MHRA. It is the UK equivalent of the FDA's MAUDE/AEMS system for medical devices.
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