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3 docs tagged with "ce-marking"

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CE marking — transitional acceptance in GB

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.

Great Britain vs Northern Ireland

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.

UKCA / CE transitional deadline tracker

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.