MHRA
英国药品和医疗产品监管局
United Kingdom
Last reviewed 2026-06-21
脱欧后，MHRA在英国运营独立的医疗器械监管框架。英国合格评定（UKCA）标志正在取代CE标志。MHRA正在开发与EU MDR不同的独立器械法规框架。
器械分类
Class I, IIa, IIb, III
审批路径
UKCA marking via UK Approved Body
核心监管职能
- ▸UKCA标志
- ▸英国器械注册
- ▸Yellow Card不良事件报告
- ▸英国批准机构监管
官方网站
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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