Medical Device Regulations
Key information
By July 2025, updated UK Medical Device Regulations will place a legal responsibility on all NHS Scotland boards to store Unique Device Identification (UDI) data, for class III and IIb devices. This will be a requirement alongside manufacturer responsibilities in the provision of this data for devices.
Suppliers, NHSScotland colleagues, and other interested partners will be able to find out more about the upcoming changes, as well as the events and reports that have shaped them, in the resources below.
The MHRA consultation on the future medical devices regulatory framework, and the UK Government response (June 2022), outlined the planned legislative requirements that will be made for UDI and implantable devices in the UK. These Medical Device Regulations are due to be phased in over a period of time (from June 2024).
The Scottish Government are working to develop policy that will improve patient safety in the context of medical device use in Scotland, by improving system wide data on medical devices.
This policy is expected to publish in early 2024. The equality impact assessment is currently available to view on the Scottish Government website.