MHRA
Medicines and Healthcare products Regulatory Agency
United Kingdom
Last reviewed 2026-06-21
Nach dem Brexit betreibt die MHRA einen unabhängigen Regulierungsrahmen für Medizinprodukte im Vereinigten Königreich. Die UKCA-Kennzeichnung ersetzt die CE-Kennzeichnung für den britischen Markt.
GERÄTEKLASSEN
Class I, IIa, IIb, III
ZULASSUNGSWEG
UKCA marking via UK Approved Body
WICHTIGE REGULIERUNGSFUNKTIONEN
- ▸UKCA-Kennzeichnung
- ▸UK-Geräteregistrierung
- ▸Yellow Card Meldung unerwünschter Ereignisse
- ▸UK Approved Body Aufsicht
OFFIZIELLE WEBSITE
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 überwacht MHRA regulatorische Änderungen, Sicherheitswarnungen und Marktsignale in Echtzeit.
{abbr} KOSTENLOS ÜBERWACHEN →