New MHRA guidance on incoming UK Post-Market Surveillance regime
The MHRA has released a suite of guidance on the new post-market surveillance (PMS) requirements for medical devices in Great Britain, ahead of the regime coming into force on 16 June 2025.
The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 amend the UK Medical Devices Regulations (MDR) 2002 by inserting a new Part 4A on PMS requirements for medical devices.
The latest suite of guidance is categorised into four main areas: guidance on implementation of the Regulations; supplementary guidance on a manufacturer’s vigilance system; periodic safety update reports; and device-specific vigilance. We summarise below some of the key points from each piece of guidance.
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