MHRA issues guidance on medical device surveillance regulation

The MHRA has published new guidance to medical device manufacturers on upcoming requirements around post-market surveillance

New Post-market surveillance regulation for medical devices comes into force across England, Scotland and Wales on 16 June 2025 and introduces key new requirements around the monitoring of medical devices after they’ve entered the market.

This includes more comprehensive data collection; shorter timeframes for reporting serious incidents and summary reporting to identify safety issues; and clearer obligations around risk mitigation and communication to protect user safety.

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Source: Digital Health, 22 January 2025