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 organisations formally designated by MHRA to carry out third-party conformity assessment of medical devices for the Great Britain market under UK MDR 2002. They perform the equivalent function to EU Notified Bodies, though UKABs are designated only for GB market access, not for the EU or Northern Ireland markets.