A collection of guidance has been published by the Medicines and Healthcare products Regulatory Agency (MHRA) to update manufacturers of medical devices on new regulations.
The Post-market surveillance (PMS) regulation for medical devices in Great Britain which will come into force on 16 June 2025. Its key new requirements are enhanced data collection, shorter timelines for reporting serious incidents and summary reporting to enable the MHRA and manufacturers to identify safety issues earlier, as well as clearer obligations for risk mitigation and communication to protect patients and users. Businesses are encouraged to start using the guidance straight away so that they understand their obligations and are ready to comply with the regulations when they take effect.
Laura Squire, MedTech Regulatory Reform Lead and Chief Officer at the MHRA, said, “The new Post-Market surveillance regulations will provide us with more safety information on medical devices in use in Great Britain, allowing us to act swiftly when needed to reduce potential harm. This will enable not only the MHRA, but the whole health system, to better protect patients.
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