CE marking transitional arrangement ends — devices on Great Britain market must hold UKCA or approved body certificate
2028-06-30 — CE marking transitional arrangement ends — devices on Great Britain market must hold UKCA or approved body certificate
The UK government has extended the CE marking transitional period, allowing CE-marked medical devices (using UK-designated standards) to continue to be placed on the Great Britain market until 30 June 2028. After this date, devices must hold either:
- A valid UKCA mark supported by a UK Approved Body (UKAB) certificate, or
- An equivalent conformity assessment route under UK MDR 2002.
Northern Ireland remains under a separate regime — CE-marked devices continue to be accepted in NI under the Windsor Framework arrangements.
Manufacturers supplying Great Britain should begin UKAB engagement now. UKAB capacity may become constrained as the 2028 deadline approaches. This date is subject to further government announcements — verify the current position with MHRA before making long-term supply commitments.
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