Roadmap towards future regulatory framework for medical devices

The government intends to introduce new regulations for medical devices that prioritise patient safety, give patients access to the medical devices they need and ensure the UK remains an attractive market for medical technology innovators.

The MHRA have published a roadmap which outlines the intended timelines for delivering the future regulatory framework for medical devices. It sets out a clear plan for improvements to the regulatory framework over the next two years and will strengthen the MHRA’s ability to keep patients safe, while encouraging the launch of innovative healthcare products.

A number of key changes to highlight include:  

  • Class I medical devices which have a sterile or measuring function with a valid MDD certificate can be placed on the GB market until 30 June 2028.
  • Custom-made devices that are compliant with the EU MDD or EU AIMDD can no longer be placed on the Great Britain market.
  • Self-certification for products that were self-declared CE marked under the MDD that can be marketed in the GB market until June 2028.
  • Self-certification for those self-declared (CE marked) under the MDR that can be marketed until June 2030.
  • The timelines for the application of the new PMS arrangement that were due to come into effect mid-2024. These now appear to have been pushed towards the end of 2024.

Read more on the implementation of future regulations here.

If you need help in understanding, navigating or direct support with technical documentation contact [email protected].

For details on our regulatory services see here.

Patrick Trotter PhD, MBA(Techmgmt)