MHRA Releases New Guidance on Medical Device Surveillance Regulations

Key Takeaways

The MHRA’s new post-market surveillance regulations for medical devices will come into effect on June 16, 2025.
Manufacturers must implement comprehensive data collection and reporting processes to ensure user safety.
Guidance published on January 15, 2025, will help manufacturers comply with the updated regulations.

New Regulations for Medical Devices

The Medicines and Healthcare Products Regulatory Agency (MHRA) has announced updated guidance to assist medical device manufacturers in navigating upcoming regulatory changes. Set to take effect on June 16, 2025, the new post-market surveillance (PMS) regulations will enforce stricter monitoring of medical devices following their market entry.

Under these regulations, manufacturers will be required to adopt more stringent data collection methods, report serious incidents within shorter timeframes, and adhere to greater obligations concerning risk mitigation and safety communications. These changes aim to enhance the safety of medical devices across Great Britain while offering more clarity for manufacturers.

Laura Squire, the medtech regulatory reform lead at MHRA, emphasized the importance of these regulations, stating they would provide critical safety information on devices in use. She indicated that the improvements would allow the MHRA and the healthcare system to act swiftly to mitigate risks and protect patients.

The PMS regulations will apply to all medical devices, including in vitro diagnostic (IVD) devices and active implantable medical devices. Requirements will vary according to the risk level associated with the device.

Key aspects of the updated PMS regulation include:
– Establishing a post-market surveillance plan proportional to the device’s risk.
– Reporting serious health incidents to the MHRA within two days for public health threats or ten days for unexpected health deterioration.
– Retaining records for a minimum of ten years (or 15 years for implantable devices) and providing these records to the MHRA upon request.

Manufacturers are encouraged to implement the guidance immediately to ensure compliance with the new regulations. The MHRA welcomes feedback to identify any further enhancements needed in the guidance.

In June 2024, the MHRA released guidance to improve transparency in AI and machine learning-driven medical devices, focusing on the usage and handling of data. This initiative followed the release of the agency’s strategic AI policy paper in April 2024. Additionally, recent discussions on the regulation of digital mental health technologies were featured in the latest episode of Digital Health Unplugged, with insights from Holly Coole, the senior manager for digital mental health at the MHRA.

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