The UK Government has confirmed its decision to recognise CE-marked medical devices and IVDs compliant with the EU MDR and IVDR indefinitely in Great Britain. UKCA marking will remain available, while implementation of the announced policy still requires legislative amendments.
At a glance
- The announcement: the Government confirmed its decision on 21 October 2026.
- The scope: indefinite recognition concerns CE-marked devices compliant with the EU MDR and IVDR.
- Legacy devices: recognition of eligible MDD-compliant devices will be aligned with the applicable EU transitional arrangements.
- UKCA: the domestic conformity assessment route will remain available.
- Implementation: legislative changes are planned before 30 June 2028, subject to parliamentary approval. Current arrangements remain applicable until the changes take effect.
What has the Government decided?
The decision follows a public consultation on the future recognition of CE-marked devices in Great Britain, meaning England, Scotland and Wales.
The consultation ran from 16 February to 10 April 2026 and received 1,056 responses. It considered both the recognition of devices compliant with the EU regulations and the transitional arrangements for devices compliant with the earlier Medical Devices Directive.
The Government has decided to proceed with indefinite recognition under the MDR and IVDR and alignment of the relevant MDD transition periods. These are related measures, but they address different regulatory situations.
Government intends to proceed with Proposal 2a and not take forward Proposals 2b and 3. The announced approach therefore does not introduce a separate international reliance route for devices assigned a higher risk class in Great Britain than in the EU. The stated aim is to avoid unnecessary regulatory complexity.
What does indefinite recognition mean?
The announced policy would remove the time limit on Great Britain’s recognition of CE-marked devices compliant with Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on IVDs.
Once implemented, eligible devices would not require an additional UKCA conformity assessment solely to maintain access to the Great Britain market beyond the current recognition periods.
Indefinite recognition concerns the duration of the recognition policy. It does not make an individual device’s conformity status or certificate permanently valid.
Long-term recognition of CE marking remains distinct from maintaining the conditions of conformity applicable to individual devices.
What happens to legacy devices?
The position of devices compliant with the Medical Devices Directive 93/42/EEC (MDD) is separate.
For eligible devices, the Government intends to align Great Britain’s recognition periods with the EU arrangements for transition from the MDD to the MDR.
The response identifies a potential six-month gap between the current Great Britain deadline of 30 June 2028 and the end of the EU transition period applicable to certain devices on 31 December 2028. The announced alignment is intended to address that gap.
Government also intends to allow the continued availability on the Great Britain market of MDD-certified devices lawfully placed on the EU or Great Britain market before the end of the applicable EU transitional arrangements, mirroring the EU approach.
These remain transitional arrangements subject to applicable conditions, rather than indefinite recognition of all MDD devices. The relevant deadlines and conditions are not necessarily the same for every device category.
Does UKCA still have a role?
UKCA marking is not being abolished.
The Government confirms that it will remain available as the domestic route for placing medical devices on the Great Britain market, alongside recognition of CE marking.
The announcement therefore preserves two routes. It does not establish a general requirement to add UKCA marking to eligible CE-marked devices once the recognition policy is implemented.
The Government also describes ongoing work to modernise the UKCA framework through future pre-market legislation. The continued availability of UKCA and the development of its future requirements are distinct aspects of the wider reform programme.
What remains applicable today?
The announcement does not itself amend the legislation.
Under the current arrangements, MDR- and IVDR-compliant devices can be placed on the Great Britain market until 30 June 2030.
Eligible MDD- and AIMDD-compliant devices are subject to recognition periods ending no later than 30 June 2028, while eligible IVDD-compliant devices are subject to periods ending no later than 30 June 2030. Certificate validity and the applicable transitional conditions also matter.
These existing arrangements remain distinct from the policy announced in October.
The Government intends to make the legislative changes before 30 June 2028, subject to parliamentary approval. This is the stated implementation timetable, not confirmation that indefinite recognition is already legally in force.
Which domestic requirements remain?
Recognition of CE marking does not remove the applicable domestic requirements.
These include registration with the MHRA, appointment of a UK Responsible Person where required, and post-market surveillance obligations.
UK Responsible Person requirement applies to manufacturers established outside the UK that intend to place devices on the Great Britain market. The MHRA retains its market surveillance and enforcement role regardless of the conformity assessment route.
The geographical distinction also remains important: Northern Ireland has a separate regulatory framework, under which the EU MDR and IVDR apply.
Why this development matters
The decision addresses uncertainty about the long-term role of CE marking in Great Britain.
Its stated objectives include continuity of supply, patient access and reduced duplication of conformity assessment for manufacturers supplying both the EU and Great Britain markets. These are the intended benefits of the policy, rather than results already demonstrated.
The central development is the planned coexistence of continued CE recognition and a domestic UKCA route. Its legal implementation will depend on the forthcoming amendments, while applicable registration and post-market obligations remain part of the framework.
Official sources
- UK Government / MHRA — Government confirms indefinite recognition of CE marked medical devices
- MHRA — Consultation outcome and Government response on indefinite recognition of CE marked devices
- MHRA — Regulating medical devices in the UK
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Informational note
This article is for informational purposes only and does not constitute regulatory, legal, technical or professional advice. For applicable requirements and procedures, please refer to the official texts and current documentation issued by the competent authorities.