The UK Government has announced that CE-marked medical devices will continue to be accepted in Great Britain on an indefinite basis. Announced by the Medicines and Healthcare products Regulatory Agency (MHRA) on 21 October 2026, the decision is intended to provide greater regulatory certainty for manufacturers, reduce unnecessary duplication in conformity assessment and support continued access to medical technologies.
The announcement follows a government consultation on the future recognition of CE-marked medical devices and forms part of the UK’s ongoing reform of its medical device regulatory framework. Access the official source below.
Background: CE Marking and Medical Device Market Access in Great Britain
Great Britain comprises England, Scotland and Wales. Medical devices placed on this market are regulated under the UK Medical Devices Regulations 2002, as amended, and manufacturers can use the UK Conformity Assessed (UKCA) marking route.
The UK has also maintained arrangements allowing certain CE-marked medical devices to access the Great Britain market under specified transitional provisions. Previously, acceptance periods varied according to the type of device and the EU legislation under which it was CE-marked, with the latest existing deadlines extending to 30 June 2030.
In February 2026, the government launched a targeted consultation on proposals to recognise CE-marked medical devices indefinitely. Following consideration of more than 1,000 responses, the government confirmed its intention to proceed with legislative changes to indefinitely recognise devices certified under the EU Medical Devices Regulation (EU MDR) and the EU In Vitro Diagnostic Medical Devices Regulation (EU IVDR), while aligning transitional arrangements for devices compliant with the earlier EU Medical Devices Directive (EU MDD) with EU timelines.
What Has Changed?
The government’s announcement confirms a long-term policy direction for the recognition of CE-marked medical devices in Great Britain.
Key implications include:
Continued recognition of CE marking: The UK intends to continue accepting eligible CE-marked medical devices for the Great Britain market on an indefinite basis, rather than relying solely on time-limited transitional arrangements.
Reduced duplication for manufacturers: Manufacturers with devices already approved for the EU market may avoid the need for an additional UK approval route solely to access the Great Britain market, where the relevant recognition arrangements apply.
Greater certainty for compliance planning: The decision provides manufacturers with a clearer long-term direction when planning regulatory strategies and market access.
Continued focus on device safety: The MHRA will continue to oversee medical devices on the UK market, including monitoring safety and taking action where necessary.
The announcement concerns Great Britain. Manufacturers should assess the applicable requirements separately when placing devices on the Northern Ireland market, where different regulatory arrangements apply.
UK Requirements That Manufacturers Must Still Meet
Indefinite recognition of CE marking does not mean that manufacturers are exempt from all UK medical device regulatory requirements.
Depending on the circumstances, manufacturers placing medical devices on the Great Britain market must continue to consider the following obligations:
MHRA registration: Medical devices must be registered with the MHRA before being placed on the Great Britain market.
UK Responsible Person: Manufacturers based outside the UK generally need to appoint a UK Responsible Person to carry out specified regulatory responsibilities on their behalf.
Applicable conformity requirements: Devices must meet the relevant requirements of the applicable EU legislation for the CE marking route being used, alongside applicable UK requirements.
Post-market surveillance: Manufacturers must continue to meet relevant post-market surveillance and vigilance obligations. The MHRA retains responsibility for monitoring device safety.
Manufacturers should also distinguish between the government’s announced policy and the legislative changes required to implement it. The announcement confirms the intention to proceed with those changes; companies should consult current MHRA guidance and applicable legislation when determining the requirements for a specific device.
What This Means for Medical Device Manufacturers
The announcement provides a more predictable long-term direction for companies supplying medical devices to Great Britain. Manufacturers that already use CE marking may benefit from reduced uncertainty around future market access and the potential need for a separate UK conformity assessment route.
However, companies should not treat indefinite recognition as a blanket exemption from UK requirements. They should confirm that their device falls within the applicable recognition arrangements, maintain the necessary registrations and representation arrangements, and continue to meet relevant safety, conformity and post-market obligations.
Manufacturers planning new product launches or reviewing existing regulatory strategies should monitor the implementation of the announced legislative changes and verify the requirements applicable to their specific device type.
How C-PRAV Can Support You
C-PRAV Labs and Certifications supports manufacturers with product testing and regulatory compliance requirements for international market access.
Our Melbourne laboratory provides accredited testing services relevant to medical device compliance and CE-marking requirements. We can help manufacturers understand applicable testing needs, plan compliance activities and identify the technical documentation and testing considerations relevant to their products.
Whether you are preparing a medical device for market entry or reviewing an existing compliance strategy, C-PRAV can help you navigate testing requirements and support your international market access objectives.
Contact us to discuss your medical device testing and compliance requirements.