The UK government has confirmed that Great Britain will continue to recognise CE-marked medical devices and in vitro diagnostic medical devices (IVDs) on an indefinite basis. The announcement, issued by the Medicines and Healthcare products Regulatory Agency (MHRA) on October 21, 2026, follows a public consultation held from February to April 2026. Official MHRA announcement
What Has the UK Government Announced?
Under the decision, eligible CE-marked medical devices and IVDs approved for the EU market can continue to access Great Britain without an additional UK approval route solely because they carry CE marking. The government says this approach will reduce duplicated regulatory work for manufacturers and help maintain a stable supply of medical technologies.
According to the MHRA, more than 90% of medical devices registered for use in Great Britain currently carry CE marking. The decision is intended to provide greater certainty for manufacturers, healthcare providers, and patients.
What Does This Mean for Medical Device Manufacturers?
The announcement has several practical implications:
Long-term market access: Eligible CE-marked devices can continue to access Great Britain under the applicable recognition arrangements, without the previously anticipated end date for EU MDR- and IVDR-compliant devices.
Reduced duplication: Manufacturers may avoid pursuing a separate UK conformity assessment solely to access Great Britain when their products qualify under the CE recognition arrangements.
Continued UKCA route: UKCA marking remains available as the domestic conformity assessment route for Great Britain.
Ongoing regulatory oversight: Manufacturers must continue to meet applicable UK requirements, including post-market surveillance and reporting obligations.
Greater planning certainty: Companies can plan their regulatory strategies with more confidence while continuing to monitor UK regulatory developments.
The indefinite recognition policy does not mean that every CE-marked device automatically qualifies for the Great Britain market. Manufacturers must confirm that their products meet the applicable conditions and requirements.
Does This Decision Apply to Northern Ireland?
No. The announcement concerns Great Britain: England, Scotland, and Wales. Northern Ireland follows a separate regulatory framework under which the applicable EU medical device regulations remain relevant. Manufacturers should assess the requirements for Northern Ireland separately rather than assuming that Great Britain arrangements apply there.
What Should Manufacturers Do Next?
Medical device manufacturers planning to enter or continue supplying the UK market should:
Confirm the applicable CE conformity assessment route and supporting documentation.
Verify that the device qualifies under the current Great Britain recognition arrangements.
Check applicable MHRA registration, UK Responsible Person, importer, labeling, and other obligations.
Maintain post-market surveillance, vigilance, and incident-reporting procedures.
Monitor further MHRA guidance and legislative developments.
Although indefinite CE recognition provides greater regulatory certainty, it does not remove the need to maintain the required documentation and meet applicable UK obligations.
Contact Operon Strategist to discuss your medical device’s regulatory pathway.
How Can Operon Strategist Help?
Operon Strategist supports medical device manufacturers with UK regulatory consulting, CE marking, UKCA requirements, technical documentation, and market-entry planning. Our team can help manufacturers assess applicable MHRA requirements, review regulatory documentation, understand UK Responsible Person obligations, and plan their regulatory pathway for Great Britain. With appropriate regulatory guidance, manufacturers can prepare for market entry while maintaining the necessary documentation and post-market compliance procedures.
