The Medicines and Healthcare Products Regulatory Agency (MHRA) has issued new PMS guidance to support medical device manufacturers in preparing for upcoming regulatory changes. Taking effect across England, Scotland, and Wales on 16 June 2025, these updates are designed to strengthen the post-market surveillance (PMS) of medical devices, enhancing safety and performance monitoring once products are on the market.

Key changes in the new PMS guidance

The new PMS guidance introduces several critical updates that manufacturers must comply with:

  • Enhanced data collection: Manufacturers will need more robust systems for collecting and analysing data on device performance and safety.

  • Stricter reporting timelines: Incidents that pose a public health risk must be reported within two days; unexpected deterioration in health must be reported within 10 days.

  • Greater transparency and risk management: New rules reinforce manufacturers’ responsibilities to identify, communicate, and mitigate risks more effectively.

MHRA has stated that the goal of these changes is to “introduce clearer and more risk-proportionate PMS requirements that improve the safety of medical devices across Great Britain and provide certainty for manufacturers.”

MHRA’s focus on improving device safety

Laura Squire, Chief Officer and MedTech Regulatory Reform Lead at MHRA, highlighted the value of the new PMS guidance: “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.”

Scope of the PMS regulations

The new guidance applies to a wide range of devices, including:

  • In vitro diagnostic (IVD) devices

  • Active implantable medical devices

  • Other devices, classified according to risk

What manufacturers need to do under the new PMS guidance

To meet the requirements of the new PMS guidance, manufacturers must:

  • Establish proportionate post-market surveillance plans for all devices

  • Report serious incidents within the required timeframes

  • Retain records for at least 10 years (15 years for implantable devices), available to MHRA upon request

Manufacturers are encouraged to implement the changes now and share feedback to shape future guidance.

Related developments in AI medical device regulation

In June 2024, MHRA also published guidance on artificial intelligence and machine learning-enabled medical devices. The document aims to improve how data use is communicated and governed, building on its AI policy framework from April 2024.

Steps to prepare for the June 2025 deadline

With the implementation date for the new PMS guidance approaching, medical device manufacturers should act now to update their processes. Aligning with the latest requirements will not only ensure regulatory compliance but also strengthen patient safety and trust in medical technologies across the UK.

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