The MHRA has published a consultation on reforms to UK medical device regulations as part of finalising the details of a Pre-Market Statutory Instrument expected in 2025.

The consultation, Medical Devices Regulations: Routes to market and in vitro diagnostic devices, focuses on four areas: 

  1. introducing international reliance; 
  2. removing UKCA marking and relying on UDIs; 
  3. changes to In vitro diagnostic device classification to align more closely with the EU; and 
  4. removing sunset clauses for the UK regulations which derived from EU law.

The Pre-Market SI will refine the measures which must be taken before a product can be put on the market. As well as the topics which are part of the current consultation, it will include:

  1. increasing the classification of some devices – to improve standards of scrutiny;
  2. introducing a legal requirement for Unique Device Identification (UDI) – to align with international best practice and to keep a better track of product safety in the supply chain;
  3. use of implant cards – to help patients and to track and communicate safety concerns more easily; and
  4. new rules on what can be claimed publicly – to ensure it aligns with the intended purpose for which the device has been approved.

The current consultation closes on 5 January 2025. Further details on the proposals are below.

International reliance

The consultation proposes an international reliance scheme to enable swifter market access for certain devices, which could be placed on the market without requiring UKCA certification.

In May 2024, the MHRA announced a proposed framework for international reliance. The consultation explains the proposals for implementing that statement of policy intent, with some significant changes, notably the removal of the specific requirements for AI as a Medical Device. The MHRA has said it does not now intend to define AIaMD or introduce any AIaMD specific requirements at this time. The proposed consultation does not therefore include specific requirements for these devices.

However, there is still an exclusion in the reliance procedure for software as a medical device that relies on the 510k route in the USA to gain market access. The practical impact of this is that a lot of AIaMD currently cleared for use in the USA will not be able to use the international reliance route for UK market access (as a large number of AIaMD/SaMD in the USA use the 510k route). 

The MHRA is proposing that only certain requirements in the UK Medical Device Regulations will apply to devices that already have marketing authorisation in Australia, Canada, the US, or the EU. Subject to some exceptions and depending on the Class of the device, such devices would then be able to gain access to the Great Britain market without needing a UKCA certification. The MHRA is also in discussions to explore reliance on Japanese approvals.

UKCA marking

Currently, UK Conformity Assessment (UKCA) marking is required to be placed on medical devices or their sterile pack in order to be marketed in Great Britain. The consultation is seeking views on removing this requirement.

Previously, the MHRA invited views on whether a Unique Device Identification (UDI) system should be adopted with the aim of improving the traceability of medical devices, to which 91% of respondents were in favour. Manufacturers currently must maintain a separate line of UKCA-marked products for the GB market, so the consultation will inform a determination on whether the UKCA marking should be removed to rely solely on the UDI system. 

In vitro diagnostic devices

The consultation proposes that IVD devices will be classified into four risk classes, which will align closely with the EU regime. Views on future regulatory requirements to gain market access are sought, with some differences to the EU regime proposed. 

The MHRA propose that a UKCA self-declaration of conformity and QMS certification to ISO 13485 are suitable pre-market controls to ensure that a Class B IVD device is safe for patient use (as opposed to requiring a CE conformity assessment by a notified body in the EU). 

Assimilated EU law

Four pieces of EU law which are referred to in the UK medical device regulations were due to expire on 26 May 2025. The MHRA proposes to remove the revocation date of those regulations so that they will continue to apply in Great Britain until they are replaced with an updated UK statutory framework.

Post-market surveillance

This consultation follows the publication of the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024, which were laid before Parliament on 21 October 2024. We have previously published detailed analysis of the PMS Regulations here.

Looking ahead

As a relatively limited consultation, it is expected that the response will come in the early part of 2025, with a Pre-Market SI published shortly afterwards. The consultation forms part of the MHRA’s wider plans for MedTech regulatory change. The MHRA published its updated Roadmap towards the future regulatory framework for medical devices in January 2024 which sets out intended timescales for the delivery of the future core regulations.  

If you have any questions, please contact a member of our Healthcare team.

This article was written by Rory Trust and Matthew Pegler