MHRA issues guidance on medical device surveillance regulation

The Medicines and Healthcare Products Regulatory Agency (MHRA) has issued fresh guidance to help medical device manufacturers prepare for upcoming regulatory changes.

The post-market surveillance (PMS) 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.

The new regulations are part of wider regulatory reform, which MHRA said would “introduce clearer and more risk-proportionate PMS requirements that improve the safety of medical devices across GB (Great Britain) and provide certainty for manufacturers.”

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 GB, 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.”

The PMS regulations will apply to medical devices, including in vitro diagnostic (IVD) devices and active implantable medical devices, and vary based on the risk level posed to patients.

The guidance, published by MHRA on 15 January 2025, is designed to help medical device manufacturers understand the nuances of the changes and what action they need to take “to ensure their devices continue to meet appropriate standards of safety and performance.“

Other requirements of the updated PMS regulation include:

• Establishing and maintaining a post-market surveillance plan and system for all devices placed on the market, proportionate to the device’s risk
• Reporting serious incidents to MHRA within two days for public health threats or 10 days for unexpected health deterioration
• Keeping records for at least 10 years, or 15 years for implantable devices, and providing it to MHRA upon request

Squire added: “Manufacturers should start using the guidance straight away so that they are ready to comply with the regulations. Feedback is encouraged and will help us to address additional enhancements should they be needed.”

Meanwhile, in June 2024, MHRA published guidance to support better transparency around AI and machine learning-driven medical devices, with a focus on how data is used and acted on.

This followed the publication of the agency’s strategic approach to AI policy paper in April 2024.

The latest episode of Digital Health Unplugged features Holly Coole, senior manager for digital mental health at the MHRA, discussing the regulation of digital mental health technologies.