How CE marking is accepted on the Great Britain market under transitional arrangements — the current deadline of 30 June 2030, what devices are covered, the conditions that apply, and what manufacturers must still do even when relying on CE marking for GB access.
MHRA's Exceptional Use Authorisation mechanism — when MHRA can authorise the use of an unlicensed or non-UKCA-marked device in exceptional circumstances, including public health emergencies.
How the UK's exit from the EU created two distinct medical device regulatory regimes within the United Kingdom — UK MDR 2002 and UKCA marking for Great Britain, and EU MDR/IVDR and CE marking for Northern Ireland under the Windsor Framework.
A chronological overview of the key regulatory transitions affecting medical device manufacturers operating in the UK market since Brexit — UKCA implementation, CE marking grace periods, MHRA registration deadlines, and the Northern Ireland Windsor Framework.
The Unique Device Identification (UDI) system for medical devices in Great Britain — current requirements, MHRA's implementation timeline, UDI structure (DI and PI), and how UK UDI relates to EU UDI requirements.
A tracker of key UKCA marking and CE marking transitional deadlines for the GB market — current status as of May 2026, and what manufacturers need to do before 30 June 2030.
How to correctly apply the UKCA mark under UK MDR 2002 — who can affix it, what it must look like, where it must appear, the UKAB identification number, and the transitional CE marking acceptance for the GB market until 30 June 2030.