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 approach to this reform was outlined in the government response to the 2021 consultation on the future regulation of medical devices in the UK. The government will ensure that there is a proportionate, phased approach to the implementation of the future regulatory framework, which supports system readiness and minimises the risk of supply disruption for UK patients.
This guidance has been updated with revised Roadmap towards the future regulatory framework (published 11 December 2024) which provides a further update on the intended timelines to implement the future medical device regulations.
The regulations will be delivered though secondary legislation. The first piece of legislation was laid in 2024 and updates post-market surveillance requirements. Further Statutory instruments will follow in 2025 and 2026 to introduce new pre-market requirements including international reliance, and further enhancements to the regulations…
