2 docs tagged with "ukab"

Class IIa · IIb · III — UK Approved Body routes

The UK Approved Body conformity assessment routes for Class IIa, IIb, and III medical devices under Schedule 3 of the UK MDR 2002 — QMS audits, type examination, design dossier assessment, and the certificate types issued.

Conformity assessment — overview & route selection

How conformity assessment works under the UK MDR 2002 — the available routes by device class, the role of UK Approved Bodies, how to select the right route, and what the process produces.