On 21 October 2026, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published the outcome of its public consultation on the long-term recognition of CE-marked medical devices. The UK Government has decided to proceed with legislation to indefinitely recognise CE-marked medical devices and IVDs certified under the EU Medical Devices Regulation (EU MDR) and the EU In Vitro Diagnostic Medical Devices Regulation (EU IVDR), while adjusting the transitional arrangements for devices that comply with the old EU Medical Devices Directive (MDD) so that they align with the EU transition timelines.
The public consultation ran from 16 February 2026 to 10 April 2026 and received 1,056 responses. The policy changes are intended to reduce duplicate approvals, lower the regulatory burden on companies, and secure the continued supply of medical devices to the UK market.
These changes mainly apply to Great Britain (England, Scotland and Wales). Northern Ireland continues to apply its existing regulatory arrangements for medical devices.
1. The three core decisions
1.1 Proceeding with indefinite recognition of EU MDR and EU IVDR devices
The UK Government has decided to proceed with legislation to indefinitely recognise CE-marked medical devices and IVDs certified under the EU MDR and EU IVDR. These devices will no longer be required to go through a duplicate UK approval process solely to enter the UK market.
1.2 Adjusting the transitional arrangements for MDD devices
The UK Government has decided to adjust the transitional arrangements for devices that comply with the MDD, so that the recognition periods in Great Britain align with the corresponding EU transition timelines. This reduces the risk of supply disruption caused by mismatched transition deadlines.
The specific deadlines still depend on the device class and on whether the device meets the applicable conditions of the EU transition arrangements. It should not be assumed that all MDD devices can be placed on the market until 31 December 2028.
1.3 Not proceeding with the proposed separate international reliance route
Earlier, the MHRA had proposed introducing a dedicated international reliance route for CE-marked devices that are classified at a higher risk level in the UK than in the EU.
Based on the formal consultation outcome, the Government has decided not to proceed with this separate route proposal. The main consideration was that the route could add regulatory complexity, while its potential safety benefits would not justify the additional regulatory burden.
It is important to note that indefinite recognition of the CE mark does not mean the removal of UKCA. The domestic UKCA conformity assessment route remains in place, and companies can still choose the applicable compliance route based on their products.
2. Which requirements remain unchanged
Indefinite recognition of the CE mark mainly changes market access arrangements. Companies must still meet the applicable UK compliance obligations.
| Compliance requirement | Specific requirement |
|---|---|
| MHRA registration | Complete UK medical device registration in accordance with the applicable requirements. |
| UK Responsible Person (UKRP) | Manufacturers based outside the UK must appoint a UK Responsible Person as required. |
| Post-market surveillance (PMS) | Continue to meet the post-market surveillance obligations applicable in the UK. |
| Incident reporting | Report relevant safety incidents and field safety corrective actions as required. |
| UKCA route | UKCA remains valid, and the domestic UK conformity assessment route is retained. |
The MHRA will continue to monitor medical devices on the UK market and to track safety issues through channels such as the Yellow Card reporting scheme. Companies must not stop meeting their UK registration, post-market surveillance and incident reporting obligations because of the indefinite CE recognition policy.
3. UKCA route and legislative timeline
3.1 Key dates
| Date | Policy development |
|---|---|
| 16 February 2026 | Public consultation launched. The MHRA sought views on the indefinite recognition of CE-marked medical devices and the transitional arrangements for MDD devices. |
| 10 April 2026 | Public consultation closed, with 1,056 responses received. |
| 21 October 2026 | Formal consultation outcome published. The Government confirmed that it will proceed with legislation on indefinite CE recognition and the adjustment of MDD transitional arrangements. |
| Next stage | The specific implementation of the legislative changes will be subject to the formal amending regulations and subsequent official guidance. |
3.2 Policy changes by certification route
| Product certification route | Policy change |
|---|---|
| Devices certified under the EU MDR | The Government has decided to proceed with legislation for indefinite recognition. |
| Devices certified under the EU IVDR | The Government has decided to proceed with legislation for indefinite recognition. |
| Devices certified under the EU MDD | GB transitional arrangements will be adjusted to align with the corresponding EU transition timelines; the specific deadlines depend on the device class and applicable conditions. |
| UKCA route | Retained, and the wider modernisation of the relevant regulations is still under way. |
4. Stakeholder feedback
4.1 Overall industry support for indefinite recognition
The consultation received 1,056 responses. A majority of respondents supported the indefinite recognition of CE-marked EU MDR and EU IVDR devices, considering that the measure would reduce duplicate approvals, lower the administrative burden, and help innovative medical technologies enter the UK market.
For MDD devices, a majority of respondents likewise supported aligning with the EU transition deadlines in order to reduce the risk of disruption to medical device supply.
4.2 Regulators’ continued focus on device safety
Some stakeholders raised concerns about regulatory oversight after indefinite recognition, the allocation of accountability, and the UK’s ability to independently assure the safety and performance of devices.
The MHRA stated that it will continue to monitor medical devices on the UK market and to identify and address safety issues through post-market surveillance, incident reporting and international regulatory cooperation.
4.3 Trade associations welcome the decision
the Association of British HealthTech Industries (ABHI) welcomed the decision on indefinite recognition, considering that clearer regulatory policy supports company investment decisions, reduces the burden of duplicate regulation, and secures the continued supply of medical devices, IVDs and digital health technologies.
5. Implications for medical device companies
1. Companies that already hold CE certificates: indefinite recognition is expected to reduce duplicate approvals, but companies should still follow the formal entry into force of the relevant legislation.
2. Companies planning to enter the UK market: they must still complete MHRA registration, appoint a UK Responsible Person and meet post-market surveillance obligations as required.
3. Companies planning UKCA registration: the UKCA route is retained, and companies should choose a route based on their product certification status, market plans and subsequent regulatory changes.
4. Companies holding MDD certificates: they should verify whether their devices meet the extension conditions and plan the subsequent certification transition according to the applicable transition deadlines.
5.1 Scope of application
This policy applies to the regulatory framework for Great Britain (England, Scotland and Wales). Northern Ireland continues to apply its existing regulatory arrangements for medical devices. For guidance on the regulation of devices in Northern Ireland, refer to the published guidance on the Regulation of devices in Northern Ireland.
Disclaimer
This article is provided for general information only and does not constitute legal or regulatory advice. The legislative changes described above are subject to the formal amending regulations and subsequent official guidance. Companies should verify the latest requirements against the official sources below and seek professional advice where necessary.