A significant regulatory development provides long-term certainty for manufacturers supplying Great Britain, reducing the prospect of duplicated conformity assessment requirements.
On 21 October 2026, the UK Medicines and Healthcare products Regulatory Agency (MHRA) announced that the government intends to continue recognising CE-marked medical devices and in vitro diagnostic medical devices (IVDs) in Great Britain on an indefinite basis. The decision provides welcome long-term certainty for manufacturers supplying the GB market and represents an important step in the UK’s ongoing medical device regulatory reform programme.
The announcement follows a public consultation conducted between 16 February and 10 April 2026, which received 1,056 responses from manufacturers, UK Responsible Persons, notified bodies, approved bodies, healthcare professionals, patient groups and other stakeholders.
Following consideration of the responses, the government confirmed that it intends to proceed with indefinite recognition of devices certified under the EU Medical Devices Regulation (EU MDR 2017/745) and the EU In Vitro Diagnostic Medical Devices Regulation (EU IVDR 2017/746), alongside changes to transitional arrangements for certain legacy devices.
What does this mean for manufacturers?
Under the existing arrangements, CE-marked medical devices can be placed on the Great Britain market under transitional recognition provisions, subject to specific conditions and deadlines. Depending on the applicable legislation and device type, these arrangements currently extend to 30 June 2028 or 30 June 2030.
The government’s decision is intended to remove the fixed end date for recognising devices compliant with the EU MDR and EU IVDR. Once the necessary legislative changes have been implemented, manufacturers will not need to obtain UKCA certification solely to maintain Great Britain market access for devices eligible for this CE recognition route.
This is particularly significant for manufacturers already supplying both the EU and GB markets. It reduces the prospect of duplicating conformity assessment activities, associated costs and administrative work simply to maintain access to Great Britain. It should also support continuity of supply and help manufacturers plan their regulatory strategies with greater confidence.
The government also intends to align Great Britain’s transitional arrangements for devices compliant with the former EU Medical Devices Directive (MDD) with the corresponding EU transition timelines. This is a separate but related measure intended to reduce the risk of disruption for manufacturers still relying on qualifying legacy-device arrangements.
However, the legislative changes required to implement these decisions have not yet taken effect. Manufacturers must continue to comply with the existing recognition arrangements and applicable deadlines until the changes are implemented.
UK-specific obligations remain in place
Indefinite recognition of CE marking does not mean that manufacturers can supply devices in Great Britain without meeting UK-specific regulatory requirements.
Manufacturers must continue to address applicable obligations, including:
- MHRA registration: Devices must be registered with the MHRA before being placed on the Great Britain market, in accordance with the applicable requirements.
- UK Responsible Person: Manufacturers established outside the UK must appoint a UK Responsible Person where required.
- Post-market surveillance and vigilance: Manufacturers must continue to comply with applicable UK requirements for monitoring device safety, reporting incidents and taking appropriate corrective action.
- Ongoing conformity and safety: Devices must continue to meet the requirements applicable to their conformity assessment route. The MHRA retains its market surveillance and enforcement powers and will continue to oversee the safety of devices supplied in Great Britain.
The UKCA marking route will also remain available as the domestic conformity assessment pathway. The government is continuing to modernise this route as part of its wider regulatory reform programme, alongside plans to develop a more adaptable framework for medical devices and emerging technologies, including software and artificial intelligence-enabled devices.
The consultation also considered introducing a separate international reliance route for certain devices classified at a higher risk level in Great Britain than under EU rules. Following the consultation, the government decided not to proceed with that proposal as presented, having concluded that it could introduce disproportionate regulatory complexity.
What should manufacturers do now?
Manufacturers currently supplying Great Britain, or planning to enter the market, should review their existing regulatory arrangements and ensure that they remain compliant with the requirements currently in force.
For manufacturers relying on CE marking under the EU MDR or EU IVDR, the announcement provides welcome reassurance that a separate UKCA conformity assessment is not intended to become a long-term requirement solely for accessing the GB market. Nevertheless, manufacturers should continue to monitor the implementation of the government’s decision and ensure that their UK registration, UK Responsible Person arrangements and post-market surveillance activities remain up to date.
The position for legacy devices certified under the former MDD or IVDD should be considered separately, as the transitional arrangements and applicable deadlines differ from those for MDR- and IVDR-compliant devices.
It is also important to distinguish Great Britain (England, Scotland and Wales) from Northern Ireland, which operates under a different regulatory framework for medical devices.
Looking ahead
The government’s decision represents a positive development for the medical device industry, offering greater predictability, reducing the prospect of unnecessary regulatory duplication and supporting continued access to medical technologies in Great Britain.
For manufacturers supplying both the EU and GB markets, the direction of travel is encouraging: CE marking is intended to remain a recognised route to the Great Britain market indefinitely, while UK-specific regulatory obligations and appropriate safety oversight will continue to apply.
Manufacturers should, however, continue to follow MHRA updates until the necessary legislative changes have been implemented.
