5 docs tagged with "approvedbodies"

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.

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.

The stages of a UK Approved Body audit — from initial application through document review, on-site audit, certificate decision, and ongoing surveillance.

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.

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.