A suite of guidance has been published by the Medicines and Healthcare products Regulatory Agency (MHRA). This guidance is designed to help medical device manufacturers understand and prepare for the new Post-market surveillance (PMS) regulation for medical devices in Great Britain (GB) which will come into force on the 16th June 2025.
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.
These new regulations are part of wider regulatory reform and will introduce clearer and more risk-proportionate PMS requirements that improve the safety of medical devices across GB and provide certainty for manufacturers…
