MHRA
Medicines and Healthcare products Regulatory Agency
United Kingdom
Last reviewed 2026-06-21
Après le Brexit, la MHRA exploite un cadre réglementaire indépendant pour les dispositifs médicaux au Royaume-Uni. Le marquage UKCA remplace le marquage CE pour le marché britannique.
CLASSES DE DISPOSITIFS
Class I, IIa, IIb, III
VOIE D'APPROBATION
UKCA marking via UK Approved Body
FONCTIONS RÉGLEMENTAIRES CLÉS
- ▸Marquage UKCA
- ▸Enregistrement des dispositifs UK
- ▸Déclaration Yellow Card des événements indésirables
- ▸Supervision des UK Approved Bodies
SITE OFFICIEL
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.
MedFlux surveille les changements réglementaires, alertes de sécurité et signaux de marché de MHRA en temps réel.
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