On October 21, 2026, the UK government published its response to a consultation by the Medicines and Healthcare products Regulatory Agency (MHRA): Medical devices and in vitro diagnostics with CE marking under the MDR or IVDR are to be recognized indefinitely in Great Britain. So far, this is only planned until June 30, 2030.
The key points:
- No additional national assessment for CE marked devices under the MDR and IVDR, regardless of risk class
- MDD devices: The British transition periods are to be aligned with the EU (December 31, 2027 or December 31, 2028, depending on the class)
- A UK Responsible Person and MHRA registration remain mandatory
- UKCA marking remains available as a national route
The legislative changes are to be made before June 30, 2028. Parliament still has to approve them. The decision is based on a consultation with 1,056 responses.
For manufacturers of software as a medical device, CE marking under the MDR is thus to remain the route to the UK market in Great Britain in the long term. Additional UKCA marking would not be required.
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