The UK government has published its response to the recent consultation on the UK Medical Devices Regulations. As highlighted throughout the process to date, the focus is on improving regulatory scrutiny and oversight of medical devices and IVDs in the UK. Changes are aimed at closer alignment with international best practice and to ensure that Great Britain has risk proportionate regulations. Changes are not intended to introduce the EU Medical Devices Regulations into UK law, although there are of course similarities, which has been welcomed by those responding to the consultation.
There were four key areas under consultation: (1) International reliance, (2) UKCA marking, (3) IVD devices, and (4) Assimilated EU law. We have set out a summary on each of these below.
Where are we now?
The UK government's review of the regime governing medical devices and in vitro diagnostic devices (IVDs) has been on-going for several years, with changes being made to the UK Medical Devices Regulations 2002 (UK MDR) slowly and incrementally. The initial consultation on overhauling the UK regime took place in 2021, and the government's response to this was published in June 2022 (see our blog here). Many of the changes discussed below stem from this first consultation. More recently, new regulations on medical device post-market surveillance requirements came into force in June 2025 (see our blog here).
The recent consultation response is another step in the review process. The government has stated that the measures to be introduced reflect its commitment to the UK's Life Sciences Section Plan and Industrial Strategy and the 10 Year Health Plan for England (see our blog here), through "reduc[ing] unwarranted barriers to market entry and to deliver transformative technologies to patients faster."
The measures to be introduced will apply in Great Britain (GB) only, as Northern Ireland (NI) continues to follow the EU Medical Devices Regulations post-Brexit.
Draft legislation is due to be published later this year, and the consultation response notes that transition periods will be included commensurate with the scale of changes, and guidance will be published.
Key areas of reform
1. International reliance
The UK government's intention to introduce international recognition of regulatory "approvals" of medical devices has been under review for some time, with proposals outlined back in May 2024 (see our blog here).
Four jurisdictions were identified by the MHRA as having a "comparable" regulatory system in place to Great Britain: Australia, Canada, the EU and the USA. The MHRA proposed that approvals or certificates granted by the relevant authorities in these jurisdictions could be relied upon, subject to compliance with certain conditions. This would reduce duplication of regulatory assessment, with the hope that this would increase patients access to safe medical devices.
The UK government intends to proceed with implementing three of these, as set out below. Eligibility for each route will be based on classification (in accordance with the UK MDR) and type of prior approval.
| Route | Eligible devices | Conditions to be met |
|---|---|---|
| 1 | Low risk devices (e.g. Class I or Class A) that comply with device legislation in Australia, Canada and the USA. |
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| 3 | 'Non-active' devices (excluding those covered by Route 4) that comply with device legislation in Australia, Canada or the USA, subject to certain exceptions and restrictions. |
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| 4 | Varied, including certain non-implantable devices, devices which incorporate an ancillary medicinal substance, certain active devices, software of a medical device and certain implantable devices, that comply with device legislation in Australia, Canada or the USA, subject to certain exceptions and restrictions. |
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Recognition of EU CE marking (Route 2) will not be implemented at this time. The UK government noted that a recurring theme from stakeholders related to the need for indefinite extension of the UK recognition of EU CE marked medical devices (which is currently due to come to an end in July 2028 or July 2030 depending on the type of device). The UK government has confirmed it intends to consult further on the reliance routes for EU CE marked devices and whether this should be extended indefinitely, and so recognition will not proceed with the other routes proposed.
2. UKCA marking
The UK government has confirmed that it intends to remove the requirement for a UKCA marking to be affixed to a medical device, or its sterile pack, to be placed on the GB market where the product has undergone conformity assessment in the UK (however, this will remain optional, addressing a concern from stakeholders that the change would lead to relabelling activities)
Instead, manufacturers will need to assign a Unique Device Identification (UDI) to their device and the UDI will need to be registered in a publicly accessible database.
Transitional periods of three years for devices and five years for IVDs will apply and the change will be implemented once the public database is operational.
3. IVDs
The UK government has recognised that the current classification of IVDs under the UK MDR is outdated. As such, it intends to change the existing list-based classification of IVDs to a risk based framework. This approach generally aligns with principles developed by the International Medical Device Regulators Forum (IMDRF) and indeed, the classification of IVDs in the EU.
In summary, the classification of IVDs in the UK will be as follows, once implemented:
- Class A IVD devices: UKCA self-declaration of conformity.
- Class B IVD devices: UKCA self-declaration of conformity + QMS certification.
- Sterile Class A and B IVD devices: Class A or Class B route + UKCA conformity assessment by an approved body for sterility requirements only.
- Class C IVD devices: UKCA conformity assessment by an approved body.
- Class D IVD devices: UKCA conformity assessment by an approved body + batch release testing + common specification requirements.
As a result of the consultation, changes relating to Class B IVDs have been made aimed at providing a more risk proportionate approach for low-medium risk IVDs. On this point, the government confirms that it considers QMS certificates to provide a "robust framework for maintaining high-quality standards". The QMS certification must be to the standard ISO 13485, issued either by a UKAS accredited body, or by International Accreditation Forum accredited certification bodies from Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP) countries. Guidance will be issued, including on which version of the ISO standard must be met.
Concerns were raised from stakeholders about UK-specific accreditation and the divergence of conformity assessment routes between GB and NI (which continues to follow EU rules). In response, the government has confirmed that it is only the conformity assessment route that will differ (i.e. self-assessment in the GB vs third party assessment in the EU) and the technical requirements for Class B will be similar in both GB and NI. Further, the government has repeated its intention to update the essential requirements for IVDs to align with the rules under the EU IVDR.
4. Assimilated EU law
This proposal was more time critical than those set out above and the government's approach to four pieces of assimilated EU law was published in February 2025. The resulting legislation came into force on 24 May 2025.
The four pieces of assimilated EU law related to: the common technical specifications for IVDs; electronic instructions for use of medical devices; particular requirements for medical devices manufactured utilising tissues of animal origin; and the designation and the supervision of approved bodies.
These pieces of legislation are referred to in the UK MDR, but were due to be "sunsetted" (removed from UK law) in May 2025. This date has now been removed so that the legislation will continue to apply in GB until updated laws come into effect.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
