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 I self-declaration pathway
How manufacturers of Class I medical devices self-declare conformity under the UK MDR 2002 — the process, required documentation, MHRA registration, and the three Class I sub-categories that require partial UK Approved Body involvement.