Medical Device Regulations

The legal and regulatory drivers behind the programme are the Independent Medicines and Medical Devices Safety Review (IMMDS) and the Medicines and Medical Devices Act 2021 (MMDA) which resulted in a UK-wide commitment to establish a UK Medical Device Information System (MDIS).

Work to reshape the future of UK Medical Device Regulations is well underway and the legal text for the Pre-market regulations which will include the UDI requirements is anticipated in Summer 2025.

Medicines and Healthcare products Regulatory Agency (MHRA)’s  Roadmap towards the future regulatory framework for medical devices indicates that there will be a legislative requirement for all UK health and care providers to collect data relating to the devices that are used in patient care, with the initial focus being on implantable devices.