UK MHRA Announces Consultation on the Indefinite Recognition of CE-marked Medical Devices

The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a targeted consultation on the indefinite recognition of the CE-mark for medical devices placed on the market in Great Britain (“GB”) (i.e., England, Scotland and Wales) (the “Consultation”), which will run until 10 April 2026.  The Consultation aims to complement wider planned reforms to the UK medical device regulatory framework that are expected to be announced later this year.  The Consultation applies to GB only as medical devices placed on the Northern Ireland market must comply with the EU medical devices framework and be CE-marked in any event.

The Consultation follows an earlier public consultation on pre-market regulatory changes for medical devices and in vitro diagnostic (“IVD”) devices (see our prior blog post here), where the MHRA announced its intention to further consult on the indefinite recognition of CE-marked medical devices in GB.

Background

Following Brexit, in 2021, the MHRA introduced UKCA-marking as an independent product safety regime for medical devices placed on the UK market.  The original intent was for the UKCA mark to become mandatory, subject to transitional provisions to allow CE-marked devices to be placed on the GB market until June 2023.  However, those transitional measures have been repeatedly extended.  Currently, manufacturers with devices that comply with the EU medical devices framework can place them on the GB market, potentially up until June 2028 or June 2030, depending on the specific device and relevant EU legislation the device complies with.

The Consultation proposes to further amend the UK Medical Devices Regulations 2002, as amended (“UK MDR”), to allow manufacturers of CE-marked devices to continue to place them on the GB market with a view to ensuring continuity of supply of devices across GB.

Latest Proposals

The Consultation addresses three key proposals:

1. An extension to the current GB transitional arrangements for devices that comply with the prior EU Medical Device Directive (“EU MDD”) to align with the transitional timelines published by the EU.
   • The EU Medical Device Regulation 2017/745 (“EU MDR”) came into force in May 2021, replacing the EU Medical Devices Directive 93/42/EEC (“EU MDD”).  The European Commission extended transitional arrangements for certain medical devices to transition from the EU MDD to the EU MDR until 31 December 2028, whereas the current transitional period under the UK MDR expires on 30 June 2028.  The MHRA is thus proposing to extend the current transitional period for devices that comply with the EU MDD to 31 December 2028, to allow such devices to continue to be placed on the GB market for the same period as they may be placed on the EU market.

2. Indefinite recognition of devices that comply with the EU MDR or the EU In Vitro Diagnostic Medical Device Regulation 2017/746 (“EU IVDR”).
   • Under current GB arrangements, after 30 June 2028 or 30 June 2030 (depending on the specific device), CE-marked devices can no longer be placed on the GB market.  Instead, all devices will need to conform with the UK MDR.The MHRA is proposing to extend the current transitional arrangements, allowing devices that comply with the EU MDR or EU IVDR to be placed on the GB market indefinitely.  The MHRA is particularly interested in views on whether this change should apply for all devices, or only for devices which are classified the same or lower, risk category under UK MDR as they are under the relevant EU device regulations.  
     • If indefinite recognition is accepted for all CE-marked devices, this would in effect mean that the classification rules under the EU MDR / EU IVDR are accepted for all devices on the market in GB. If, however, indefinite recognition applies only for devices that are classified as the same, or lower, risk category in GB, this would mean that the GB classification rules would apply and take precedence over the EU classification rules in cases where the device classification is higher under the UK MDR.
     Devices that are recognised under this proposal would be able to continue to be placed on the GB market without additional checks by any UK Approved Body.
   • Manufacturers would regardless need to continue to (i) register their device with the MHRA, (ii) comply with post-market surveillance requirements under the UK MDR and (iii) notify the MHRA if the CE mark under the EU MDR or EU IVDR, as applicable, is withdrawn or suspended, and in turn remove the device from the GB market.

3. The introduction of international reliance routes for devices that comply with the EU MDR or EU IVDR where the classification is higher under the UK MDR.
   • For devices that are classified higher under the UK MDR, compared with the EU MDR/EU IVDR, the MHRA is proposing an international reliance route.  This route would be in place from 30 December 2030, when the current transitional arrangements end. 
   • Manufacturers would have the choice between either (i) the international reliance route or (ii) the UKCA conformity assessment process.  The former would require a review by an UK Approved Body but may be more streamlined than the UKCA conformity assessment process due to reliance on assessments that will have already been performed in the EU.
   • Self-declared CE-marked Class I and Class A devices, which would be classified as Class IIa under the UK MDR, would not be eligible for the international reliance route and would instead need to undergo UKCA conformity assessment.

Next Steps

These changes will help realise the UK’s aims to become “one of the top three fastest countries in Europe for access to MedTech by 2030.”  They will also help to deliver key commitments in the government’s 10-Year Health Plan for England and Life Sciences Sector Plan to transform the NHS for the benefit of patients, drive economic growth in the UK’s life sciences sector, and improve the AI and medical device landscape in the UK. 

Interested parties wishing to respond to the Consultation should do so before 10 April 2026 using the survey found here. 

If you would like to discuss the MHRA’s Consultation and what the proposed changes to the regulatory framework for medical devices in the UK may mean for your company’s operations, please contact our specialist UK and EU medical device regulatory team.

Covington will continue to follow developments and provide further updates, including on future planned MHRA consultations.