Updated roadmap for UK medical device reforms published by the MHRA

This iteration of the MDR Roadmap replaces a previous version published in January 2024, which anticipated that updates to the post-market requirements for medical devices and IVDs would be in force by the end of 2024, with further updates to the "core regulations" covering the pre-market requirements being laid before parliament in early 2025 and coming into force in summer 2025. A number of these dates have passed and this update will help industry stakeholders plan for when new obligations are likely to take effect.

The MDR Roadmap is now divided into four core tranches of work:

1. New regulations for post-market surveillance: this work package is the most progressed. The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 were introduced before the UK Parliament in October 2024 (PSMR). We have written previously about the requirements which will be introduced by PSMR. The MDR Roadmap is consistent with the timings anticipated in the draft legislation; industry can expect the PSMR requirements to come into force in summer 2025.
2. New regulations for pre-market requirements: we wrote in November about the key features of the pre-market requirements the MHRA is currently consulting on, including international reliance, UKCA marking, and classification and market access for IVDs. The MDR Roadmap indicates that consultations on the new legislation will continue until April/May 2025. Industry should expect to receive its first insight into the substance and form of the eventual legislation between May-July 2025. The MHRA will publish the draft legislation on the website of the World Trade Organisation (WTO) for a minimum period of 60 days in order to comply with the UK’s obligations under the WTO Agreement on Technical Barriers to Trade. Implementation of the legislation is not anticipated until early 2026.
3. Policy development: this work tranche will be completed between now and Q3 2025 and encompasses the development and publication of guidance on a number of specific regulatory areas, including:
   1. new guidance on the exceptional use authorization for approval to supply a non-compliant medical device on humanitarian grounds;
   2. a statement of policy intent on early access and innovation;
   3. refinement of the MHRA's policy towards a potential health institution exemption for medical devices in the UK¹; and
   4. publication of a specific IVD roadmap.
4. Software, AI and Digital Mental Health Products: the final tranche of work incorporates the publication of guidance covering specific topics relevant to software as a medical device, including guidance on: (i) the Good Machine Learning Principles published by the MHRA in collaboration with the FDA and Health Canada; (ii) artificial intelligence as a medical device; (iii) cybersecurity; and (iv) digital mental health tech.

Some questions remain as to the transition periods which manufacturers will need to comply with. Based on current information it is likely that they will be as follows:

• The requirements of PSMR will come into force six months after PSMR is passed by the UK Parliament, anticipated summer 2025.
• The rules for CE marked devices will remain unchanged as per the attached MHRA infographic, with transition periods running until 2028 or 2030, depending on the nature of the device and the EU regime the device was certified under.
• For device that are UKCA marked, the transition period for implementing the future UK MDR pre-market requirements are currently less clear. The MHRA has set out its current intentions in a recent blog post:
  • for medical devices, the transition period will be the earlier of: (i) three years from the date that the updated regulations take effect; or (ii) the expiry of the certificate of conformity for the device; and
  • for IVDs, the transition period will be the earlier of: (i) five years from the date that the updated regulations take effect; or (ii) the expiry of the certificate of conformity for the device.

In addition, the MHRA’s blog post also indicates that the MHRA is keeping a close watch on the EU review of the EU MDR and IVDR alongside the UK MDR process.

Authored by Jane Summerfield, Bonella Ramsay and Bea Watts.