MHRA finally agrees to the continued and indefinite recognition of the CE Mark 

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MHRA finally agrees to the continued and indefinite recognition of the CE Mark 

The OSA had exerted its pressure on its retention in order to cut red tape and reduce additional costs to the sector

The Medicines and Healthcare products Regulatory Agency (MHRA) has today announced that the UK Government will introduce indefinite recognition of CE-marked medical devices in Great Britain (England, Scotland and Wales).

The announcement follows a public consultation held between 16 February and 10 April 2026, which received over 1,000 responses from industry, healthcare professionals and other stakeholders.

Under the Government’s decision, medical devices compliant with the EU Medical Device Regulation (EU MDR) and In Vitro Diagnostic Regulation (EU IVDR) will continue to be recognised indefinitely. This will remove the previous 30 June 2030 deadline for these devices, avoiding the need for manufacturers to obtain separate UKCA certification to maintain access to the Great Britain market.

The Government also intends to extend existing transitional arrangements for legacy devices certified under the EU Medical Devices Directive (MDD), aligning these with EU timelines.

The MHRA reports that more than 90% of medical devices registered for use in Great Britain carry CE marking. Continued recognition will therefore help maintain product availability, reduce unnecessary regulatory duplication and provide greater certainty for manufacturers and suppliers.

For the optical sector, this is a welcome development, supporting continued access to CE-marked optical products, including spectacle frames, ophthalmic lenses, contact lenses and diagnostic equipment.

The UKCA conformity assessment route will remain available, while existing MHRA registration, post-market surveillance and other applicable regulatory obligations will continue to apply.

The announcement also supports the MHRA’s recently published 2030 Strategy, which seeks to strengthen international regulatory recognition and simplify market access.

OSA welcomes this decision, which provides long-term regulatory certainty for the optical industry, reduces unnecessary compliance costs and supports the continued availability of safe and effective optical products for UK consumers and healthcare professionals.

The changes remain subject to legislative implementation, and OSA will continue to monitor developments and keep members informed.  Please also see link here – Government confirms indefinite recognition of CE marked medical devices – GOV.UK“