Great Britain confirms long-term recognition of CE-marked medical devices

Revision 1 · Medical device regulation · International · Record prepared

Prepared through Iliyn’s AI-assisted editorial workflow. Source statements are not independent audits of underlying events.

The UK government says it will continue accepting CE-marked medical devices and diagnostics alongside the UKCA route.

What the record says

The Medicines and Healthcare products Regulatory Agency announced on October 21 that Great Britain will continue to recognize CE-marked medical devices and in-vitro diagnostics on a long-term basis. The decision follows a February–April public consultation. MHRA says UKCA remains the domestic route and that it will continue post-market safety monitoring.

Source details and supporting locations.

Practical next step

Manufacturers and healthcare organizations should consult the consultation response and MHRA implementation guidance for applicable requirements.

Limits and what is not established

The announcement concerns Great Britain. It does not remove safety oversight, approve a particular product or establish that every future licensing reform has been enacted. Implementation details remain subject to official guidance.

Sources checked October 21, 2026. Later notices may change instructions or arrangements.

Original sources

UK Medicines and Healthcare products Regulatory Agency: original information

Corrections and history

Read correction history

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