UK Government Confirms Indefinite Recognition of CE-Marked Medical Devices, Removing the June 2028 Six-Month Gap

UK Government Confirms Indefinite Recognition of CE-Marked Medical Devices

On 21 October 2026, the UK government published its response to the targeted consultation on the indefinite recognition of CE-marked medical devices. The government confirmed that it will legislate to recognise, indefinitely in Great Britain, devices certified under the EU Medical Device Regulation (EU MDR 2017/745) and the EU In Vitro Diagnostic Medical Device Regulation (EU IVDR 2017/746). The MHRA issued a same-day news release stating that the move avoids a separate approval process for devices already authorised in the EU and reduces duplicate assessment.

Current arrangement is time-limited

Under regulation 19B of the UK Medical Devices Regulations 2002 (MDR 2002), CE-marked devices may enter the GB market without additional pre-market review. However, recognition currently expires on 30 June 2028 or 30 June 2030, depending on the device type and the EU regulation under which it is certified.

The timing gap under regulation 19C

The issue arises from regulation 19C. After 30 June 2028, general devices must comply with EU MDR, or complete UKCA conformity assessment, before they can be placed on the GB market. The EU has extended the deadline for certain devices transitioning from MDD to MDR to 31 December 2028. Because the two timelines are misaligned, a gap of approximately six months arises in which some devices lawfully placed on the EU market cannot enter Great Britain. The government response therefore proposes aligning the GB transitional arrangements for MDD-compliant devices with the EU transition endpoint, currently 31 December 2028, while maintaining the requirements of regulation 19B of MDR 2002.

Consultation received 1,056 responses

The consultation ran from 16 February to 10 April 2026 and received 1,056 responses from device and IVD manufacturers, UK Responsible Persons, notified bodies, healthcare professionals, patient organisations and individuals. Most responses supported full indefinite recognition of CE-marked devices certified under MDR and IVDR, citing supply continuity and administrative burden.

Scope and continuing obligations

The new arrangement covers Great Britain, namely England, Wales and Scotland. Once CE-marked devices enter Great Britain, manufacturers must still appoint a UK Responsible Person, complete MHRA registration and fulfil post-market surveillance obligations. The government noted that more than 90% of devices currently registered in Great Britain carry the CE mark.

UKCA remains in parallel

UKCA has not been abolished. It remains the domestic route to the GB market. The government is updating its requirements through pre-market statutory instruments and is seeking primary legislative authority to prepare for a future device licensing regime covering software and digitally enabled devices. The two marking routes will coexist over the long term.

Legislation has not yet been finalised

The response describes proposed legislative changes. It does not set out dates for the passage and commencement of legislation, nor does it list line-by-line transitional requirements for products holding MDD certificates. The only direction currently certain for companies is that CE recognition will no longer have an expiry date.

What this means for companies already pursuing EU registration

For companies already working on EU registration, the UK route can change from a time-limited pass to a long-term parallel second market. The precondition is that the certificate itself remains valid: it must be issued by an EU notified body under the MDR or IVDR framework, and MDD certificates must follow the EU timeline through the end of 2028.

AIMEILI Regulatory Interpretation

This is a UK government policy decision to legislate, not yet an operative legal change. The response confirms the intended direction, but the implementing legislation and commencement dates have not been published. Companies should treat the announcement as a strong signal for strategic planning while continuing to comply with the existing regulation 19B and regulation 19C framework until the legislation takes effect.

Indefinite recognition is not unconditional recognition. It applies to devices that hold a valid CE mark under EU MDR or EU IVDR, or, for MDD-certified devices during the aligned transition, that remain lawful under the EU timeline. If an EU certificate lapses, is suspended or is withdrawn, the basis for GB market access under CE recognition falls away. The UK Responsible Person, MHRA registration, post-market surveillance, vigilance and device-specific obligations remain fully applicable.

The decision does not replace UKCA. UKCA remains available and relevant, particularly for devices that are not certified under the EU framework. Companies should not assume that UKCA will disappear or that the future UK device licensing regime will mirror the EU regime. The government has expressly retained UKCA as the domestic route and is preparing further legislative changes, including for software and digitally enabled devices.

Business Impact

• Reduced duplication and cost: Manufacturers with valid EU MDR or IVDR certificates can avoid a separate UK pre-market approval process for Great Britain, reducing assessment duplication, administrative workload and time-to-market.
• Supply continuity: The removal of the June 2028 cliff edge and alignment with the EU transition endpoint reduce the risk that devices lawfully marketed in the EU become unavailable in Great Britain during the approximately six-month gap.
• EU certificate becomes the gateway to Great Britain: Regulatory strategies should prioritise maintaining a valid EU MDR or IVDR certificate, including timely transition from MDD certificates by 31 December 2028 where applicable.
• UK operational requirements remain: Companies must maintain UK Responsible Person arrangements, MHRA registrations, post-market surveillance, vigilance reporting and labelling compliance for the GB market.
• Parallel UKCA planning: UKCA remains relevant for devices outside the EU certification framework and for future portfolio planning. Companies should monitor the UKCA requirements being updated through statutory instruments and the proposed future licensing regime.
• Legislative monitoring required: Because the implementing legislation, commencement dates and detailed transitional provisions are not yet published, companies should track official UK publications and update regulatory plans once the legal text is available.

Sources

GOV.UK / MHRA news release, Government confirms indefinite recognition of CE marked medical devices, 21 October 2026: https://www.gov.uk/government/news/government-confirms-indefinite-recognition-of-ce-marked-medical-devices

GOV.UK consultation and government response page, Medical devices regulations: targeted consultation on the indefinite recognition of CE marked devices, published 16 February 2026 and updated 21 October 2026: https://www.gov.uk/government/consultations/medical-devices-regulations-targeted-consultation-on-the-indefinite-recognition-of-ce-marked-devices

GOV.UK full government response PDF, Government response to the targeted consultation on indefinite recognition of CE marked medical devices, 21 October 2026: https://assets.publishing.service.gov.uk/media/6ad76f8be9713babfbe3f755/Government_response_to_the_targeted_consultation_on_indefinite_recognition_of_CE_marked_medical_devices.pdf

Verification note: The three official pages above were accessed and checked on 21 October 2026, with focus on the consultation dates, number of responses, current regulation 19B and regulation 19C deadlines, the EU transition endpoint, the proportion of CE-marked devices registered in Great Britain and the UKCA statement.

Applicability note: This article is an interpretation of publicly released UK government information and does not constitute a conclusion or commitment regarding any specific product, company or registration application. The legislative text has not yet been published. Specific requirements and commencement dates are subject to subsequent official documents, and the information may change as official updates are issued.