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Draft Great Britain medical device post‑market surveillance regulations: key MDR/IVDR divergences, broader incident definitions, prescriptive reporting and timelines, MHRA engagement, and implications for manufacturers from Summer 2025

Published on: 21 November 2024

Published by a LexisNexis Life Sciences expert
Legal News
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Article summary

What is the background that has led to the proposed legislation?

The existing legal framework in Great Britain (GB) – the Medical Devices Regulations 2002, SI 2002/618 (the UK MDR) – sets out only high-level, limited rules on post-market surveillance (PMS). The practical detail on how manufacturers must carry out PMS and meet vigilance duties is instead provided through guidance. This has resulted in variations in how different manufacturers undertake PMS for devices in GB. The draft PMS Regulations are intended to curb these differences by codifying, in legislation, PMS obligations that are more stringent, prescriptive, and proportionate to risk for medical devices placed on the market or put into service in GB. PMS denotes the mandatory system requiring manufacturers to monitor and document the real-world use of medical devices by patients, safeguarding ongoing health and safety once regulatory certification has been achieved and products distributed to the market. It obliges manufacturers to take a proactive, systematic approach to gathering data so that any necessary corrective or preventative safety actions can be identified. Manufacturers must actively use data to determine needed timely corrective or preventative safety measures...

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