The UK Medicines and Healthcare products Regulatory Agency (MHRA) has released Version 2.0 of its Medical Devices Regulatory Reform Roadmap, providing a detailed timeline for implementing significant updates to the UK’s medical device regulations. Here are the key highlights.
Post-Market Surveillance (PMS)
The new PMS regulations, which is separate from the pre-market regulations, has been released earlier this year. According to the UK roadmap, it will be debated in Parliament and made into law between November 2024 and January 2025. Initial PMS guidance will be published by March 2025, followed by final guidance in June 2025. Regulations will come into force 6 months after becoming law (targeting mid-2025).
Pre-Market Requirements
Ongoing consultations on International Reliance (IR), In-Vitro Diagnostics (IVDs), and marking systems will conclude on January 5, 2025. The government intends to release the response to the public consultation in the first half of 2025. Followed by the notification to the WTO and parliamentary debate. The implementation of the new law will come by 2026, subject to transitional provision to ensure a smooth shift. 
Source of the image: GOV.UK
Policy Development
Exceptional Use Authorisation (EUA) guidance will be released by March 2025. Finalisation of further policies to support innovation, early access, and alignment with government strategies will happen by mid-2025. IVD roadmap is expected between April-September 2025.
Regulations of Software and AI
Guidance for AI development, cybersecurity for Software as a Medical Device (SaMD), and digital mental health technologies will be issued for comment starting in early 2025, with refinements continuing through the year.
Source of the image: GOV.UK
For further updates as MHRA refines its guidance and implements these pivotal reforms, stay tuned at MDlaw.
Thanks for sharing valuable information.
I am happy to read this content and hopefully waiting for more updates.