Government confirms its policy, with legislation still to follow
The UK government plans to recognise CE-marked medical devices complying with the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) indefinitely in Great Britain. The government response published by the Medicines and Healthcare products Regulatory Agency (MHRA) on 21 October 2026 establishes the policy direction; implementation still requires legislation.
The distinction matters for market-access planning. Current arrangements allow eligible EU MDR- and IVDR-compliant devices onto the Great Britain market until 30 June 2030. The intended change would remove that fixed recognition endpoint. The government plans to make the legislative changes, subject to parliamentary approval, before the earliest relevant transition period ends on 30 June 2028. That is the intended legislative timetable, not a confirmed commencement date for a new regime. Government response, pages 18–21.
MDR and IVDR recognition differs from the MDD transition
The planned indefinite recognition covers devices complying with EU MDR and IVDR. The government will not pursue the alternative proposal for a separate reliance route where a device has a higher risk classification in Great Britain than in the EU. Its chosen approach avoids an additional access step based on that classification difference. Consultation outcome.
Legacy devices under the Medical Devices Directive (MDD) follow a different timetable. The government intends to align Great Britain’s recognition arrangements with the EU transition to MDR, whose latest endpoint is currently 31 December 2028, while retaining the conditions in regulation 19B of the UK Medical Devices Regulations 2002. This is not a blanket extension for every MDD device or indefinite validity for old certificates.
The response also provides for continued availability in Great Britain of MDD devices lawfully placed on the EU or Great Britain market before the relevant transition ends. Manufacturers should distinguish that position from placing further individual devices on the market after the transition. Certificate status, transition eligibility and stock already placed on the market require separate assessment. Government response, page 18.
UKCA remains available and Northern Ireland stays distinct
UKCA remains the domestic route for Great Britain. Existing UKCA-marked products can continue to be supplied, and the government is developing updated pre-market requirements for that pathway. Manufacturers should assess ongoing UKCA projects against their product portfolios and commercial plans rather than cancelling them on the strength of the announcement alone. MHRA announcement.
The proposed framework concerns England, Wales and Scotland. Northern Ireland continues to apply the relevant EU MDR and IVDR rules and requires CE marking; UKCA alone does not provide access there. Continued CE recognition can support UK-wide supply without making the two legal frameworks identical. Northern Ireland guidance.
Domestic obligations continue for CE-marked devices
The announcement reports that more than 90% of devices registered for use in Great Britain carry a CE mark, illustrating the importance of predictable recognition for supply planning. Manufacturers nevertheless retain local compliance responsibilities. MHRA announcement.
Manufacturers based outside the UK still need a UK Responsible Person, and devices must be registered with the MHRA. An EU authorised representative should not be treated as a substitute for the separate UK role. MHRA market-access guidance. The response also reiterates that technical documentation and conformity certificates must be prepared and available in English. Government response, page 19.
Great Britain’s strengthened post-market surveillance requirements also continue to apply within their scope, including to CE-marked devices. The regime introduced in June 2025 addresses safety and performance monitoring, serious-incident reporting and risk management. EU compliance alone should not be assumed to discharge every applicable Great Britain reporting obligation. MHRA post-market surveillance guidance.
What manufacturers can review now
A useful planning review starts by separating products according to their EU regulatory basis: MDR, IVDR or a legacy directive. Check eligibility and applicable dates for each group, then verify that UK Responsible Person, registration and surveillance arrangements cover the products actually supplied. These are planning recommendations based on the published policy, not a newly announced MHRA filing exercise.
For MDR- and IVDR-compliant portfolios, the decision reduces uncertainty around the future recognition endpoint. For legacy portfolios, the transition to the applicable newer regulation remains a live workstream. Companies should retain current compliance controls while tracking the implementing legislation before changing assumptions about legally available market access.
Sources
- Primary official sourceGovernment response to the targeted consultation on indefinite recognition of CE marked medical devices (opens in a new tab)Medicines and Healthcare products Regulatory Agency
- Supporting sourceMedical devices regulations: targeted consultation on the indefinite recognition of CE marked devices (opens in a new tab)Medicines and Healthcare products Regulatory Agency
- Supporting sourceGovernment confirms indefinite recognition of CE marked medical devices (opens in a new tab)Medicines and Healthcare products Regulatory Agency
- Supporting sourceRegulating medical devices in the UK (opens in a new tab)Medicines and Healthcare products Regulatory Agency
- Supporting sourceRegulation of medical devices in Northern Ireland (opens in a new tab)Medicines and Healthcare products Regulatory Agency
- Supporting sourceMedical devices: post-market surveillance requirements (opens in a new tab)Medicines and Healthcare products Regulatory Agency