Class I · IIa · IIb · III
Overview of the four risk classes for general medical devices under the UK Medical Devices Regulations 2002 — what defines each class, UKAB requirements, conformity assessment routes, and practical examples of devices in each class.
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.