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 a Roadmap towards the future regulatory framework for medical devices (published 9 January 2024) which sets out intended timescales for delivery of the future core regulations.
The regulations will be delivered through four Statutory Instruments. It is intended that priority measures to enhance post-market surveillance will be put in place first in 2024, with core elements of the new framework expected to be in place in 2025…
