What the 2024 UK Medical Device PMS Amendments Mean for Manufacturers?
In a significant move towards improving patient safety and product oversight, the UK has introduced new post-market surveillance (PMS) requirements under the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024. These regulations, effective from 16 June 2025, amend the UK Medical Devices Regulations 2002 by adding a new Part 4A, which outlines comprehensive PMS requirements for medical devices, including in vitro diagnostic (IVD) devices and active...
