What are UK Approved Bodies?
UK Approved Bodies (UKABs) are the UK equivalent of EU Notified Bodies — organisations designated by MHRA to carry out third-party conformity assessment of medical devices for the GB market.
Finding a UK Approved Body
How to identify the right UK Approved Body for your device — using MHRA's designated list, understanding scope of designation, and selecting a UKAB for your device type.
UKAB audit process
The stages of a UK Approved Body audit — from initial application through document review, on-site audit, certificate decision, and ongoing surveillance.
UKAB certificates
Types of certificates issued by UK Approved Bodies — QMS certificates, Design Examination certificates, Type Examination certificates, their validity period, and what suspension or withdrawal means.
Transitioning from EU Notified Body certificates
How manufacturers with EU Notified Body certificates transition to UK Approved Body certification for the GB market — legacy certificate acceptance, 2030 deadline planning, and the practical steps for UKCA transition.