MHRA publishes roadmap for future UK medical device regulation

  Posted by: Dental Design      9th January 2024

The MHRA has today published a roadmap setting out its plans for new medical device regulation. 

The roadmap, which the BDIA was pleased to discuss with the MHRA ahead of its publication, sets out a proposed consultative and legislative pathway for the introduction of a series of new Statutory Instruments (SIs). It also highlights work already completed, such as the introduction of transitional arrangements for CE-marked devices and the designation of new Approved Bodies in 2023. 

Key features of the roadmap include:

• Stakeholder discussions, to include the BDIA and other associations, regarding international recognition to continue through early 2024.
• Further stakeholder discussions to be held throughout 2024 covering all elements of the future core regulations.
• Subject to coordination between Government departments and Parliamentary time, Post-Market Surveillance SI to be laid in Parliament c. Q2 2024, along with accompanying draft guidance and webinars. 
• Towards the end of 2024, draft legal text of the future core regulations to be made available when submitted to the World Trade Organisation, with a view to the legislation being laid in Parliament at the beginning of 2025. 
• Provision for “future enhancement regulations” that will build upon the core regulations, with an associated public consultation. 

The MHRA has highlighted that elements of the roadmap are dependent on factors outside of its control, i.e. areas of draft legislation that will need sign-off from other Government departments and the availability of Parliamentary time when laying legislation. In addition, there remains the possibility for further disruption as a result of the anticipated General Election later this year, which the roadmap does not account for.

However, the roadmap represents a welcome move toward a more transparent and consultative approach by the MHRA and we are pleased to be engaging with regulator at the most senior levels on behalf of BDIA members throughout this process. 

Commenting on the roadmap’s publication BDIA Chief Executive, Edmund Proffitt, said: “It is pleasing to see the MHRA set out a clear roadmap for the future of medical devices regulation, particularly as it is so innovative and collaborative. Such an approach is a great step forward to enhancing the availability of innovative and safe health technologies to patients, as well as ensuring continuity of supply.”