General Medical Devices, Active Implantable Medical Devices and in vitro Diagnostic Medical Devices, which are defined under regulation 2 of The Medical Devices Regulations 2002.

The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2023; (14 page(s), in English)

This measure will amend the Medical Devices Regulations 2002 as applicable in Great Britain. The amendments seek to introduce clearer, risk proportionate Post-market Surveillance (PMS) requirements. This will help to improve the ability of both the manufacturer and the MHRA to identify issues with Medical Devices placed onto the Great Britain market and where necessary, take appropriate action to safeguard public health.

Some of the key changes include:

a. Increased scope of devices that must comply with the new PMS requirements, this includes CE marked devices.

b. Detail of what must be included as part of a PMS system, including the methods for collecting PMS data to support improved capturing of PMS data and harmonisation across manufacturers.

c. Enhanced serious incident reporting obligations for manufacturers to support the detection of safety issues sooner.

d. More stringent requirements for manufacturers to conduct periodic reviews of their PMS data including for implantable medical devices. This aims to support manufacturers in earlier detection of trends/signals that may have an impact on the safety of a Medical Device.

Improved coordination and collaboration between manufacturers, UK Approved Bodies and the MHRA to support regulatory oversight.