MHRA guidance on new Medical Devices Post-Market Surveillance requirements

The Medicines and Healthcare products Regulatory Agency (MHRA) has published a suite of guidance 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 take effect on 16th June 2025.

Key new requirements include enhanced data collection, shorter timelines for reporting serious incidents, and summary reporting to enable both the MHRA and manufacturers to detect safety issues earlier. Additionally, the regulations introduce clearer obligations for risk mitigation and communication to safeguard patients and users.

Businesses are encouraged to begin using the guidance immediately to understand their responsibilities and ensure compliance when the regulations come into force. These changes form part of a broader regulatory reform, introducing clearer and more risk-proportionate PMS requirements to enhance medical device safety across GB while providing certainty for manufacturers.

The new regulations will apply to medical devices, including in vitro diagnostic (IVD) devices and active implantable medical devices, used in GB. However, PMS requirements will vary depending on the device's risk level to patients. The guidance offers further details to support manufacturers in their PMS activities, ensuring their devices continue to meet appropriate safety and performance standards.

As businesses adopt the new guidance, feedback is encouraged. The MHRA welcomes input through Trade Associations, where applicable, as they work closely with the agency to identify areas for improvement. If necessary, the MHRA will update the guidance before the regulations take effect.