The MHRA has recently updated the roadmap which outlines for Implementation of Medical Devices Future Regime. This provides a further update on the intended timelines to implement the future medical device regulations.
The updated revision provides updates in 4 key areas:
Progress of Post-Market Surveillance (PMS) Statutory Instrument (SI) in Legislation
The Post-Market Surveillance (PMS) Statutory Instrument (SI) was debated in Parliament on November 28. Since no objections were raised, the motion was approved. According to the timeline below:
- The first version of the PMS Guidance is expected to be released in the first quarter of 2025.
- PMS regulations coming into effect in the first half of 2025.
- The final version of the guidance is anticipated by mid-2025.
New Pre-Market Requirements Are Currently Under Consultation
The MHRA has launched a public consultation on proposed changes to the UK medical device regulatory framework. According to the timeline below:
- The consultation is set to close on January 5, 2025
- The responses to the consultation are set to be published in the first half of 2025.
- The draft regulations are expected to be posted on the World Trade Organization (WTO) website by mid-2025.
- The SI will then be introduced to Parliament for debate later in 2025
- The new pre-market requirements set to take effect in 2026.
Policy Development in Four Areas Proposed
Four new policy and guidance documents are expected to be released in 2025. According to the timeline below, these are expected to be released on the following dates:
- Exceptional Use Authorization (EUA) Guidance, slated for release in the first quarter of 2025.
- Early Access and Innovation Policy, currently under development, with publication expected in the first half of 2025.
- Health Institution Exemption (HIE) Policy and Guidance, to be updated to align with government strategy and published by mid-2025.
- In Vitro Diagnostics (IVD) Roadmap, expected to be released in the second half of 2025.
Software Guidance Documents Expected
In addition to the above, four guidance documents related to software, including artificial intelligence (AI) and digital mental health technologies are expected in 2025. According to the timeline below, these are expected to be released on the following dates:
- A draft guidance on digital mental health technology, to be published in the first quarter of 2025.
- Guidance on Good Machine Learning Practice (GMLP) Mapping, expected to be published for comment in the first quarter of 2025.
- Guidance on AI development and deployment, anticipated for release for comment in the second quarter of 2025.
- Guidance on cybersecurity for Software as a Medical Device (SaMD), planned for publication in the second quarter of 2025.
The updated roadmap can be accessed using the following link
