UK Regulations Governing Post-Market Surveillance of Medical Devices Enter Into Force

The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 entered into force on 16 June 2024. The Regulations, which apply in Great Britain, introduce a new Part 4A to the existing Regulations governing post-market surveillance (PMS) requirements for medical devices. These include in vitro diagnostic (IVD) devices and active implantable medical devices.

The new measures are intended to clarify and strengthen the post-market surveillance requirements for medical devices in use in Great Britain. They also facilitate greater traceability of incidents and trends and allow the MHRA to act swiftly when needed, supporting better risk management and containment of safety issues and reducing harm. The Regulations include notification requirements for incidents, and preventive and corrective actions taking place after the device is first approved for the GB market.