PMS Statutory Instrument + MHRA Guidance released (Great Britain)

The Medicines and Healthcare products Regulatory Agency (MHRA) has released a guidance to assist medical device manufacturers in preparing for the new PMS Statutory Instrument in Great Britain. These regulations apply to all medical devices, including in vitro diagnostic (IVD) devices and active implantable medical devices.

Manufacturers must implement and maintain a PMS system that is aligned with the risk classification and type of the medical device. This system should incorporate processes for collecting and analysing data, as well as ongoing monitoring of the device’s safety and performance after it has been marketed. The key elements of the PMS system include:

• PMS Plan: A required plan that outlines the systematic procedures for post-market surveillance activities.
• PMS Report (PMSR): Regular reports summarizing the findings from PMS data analysis for devices of lower risk categories.
• Periodic Safety Update Report (PSUR): For higher-risk devices, a PSUR must be submitted, offering a detailed assessment of the device’s benefit-risk balance.

The MHRA encourages manufacturers to review the guidance and take necessary steps to comply before the implementation date (16th June 2025). Industry feedback is welcomed through Trade Associations to refine the regulations where needed. These updates aim to improve patient safety and provide regulatory clarity for manufacturers operating in Great Britain.

The updated requirements and guidance do not apply to products placed on the Northern Ireland (NI) market as the EU IVD Regulation 2017/746 applies to products placed on the NI market, including PMS requirements.

These new regulations are part of wider regulatory reform as the UK government intends to introduce new regulations for medical devices that prioritise patient safety, give patients access to the medical devices they need and ensure the UK remains an attractive market for medical technology innovators. The reform will be implemented through secondary legislation. The first piece of legislation in this reform was the PMS Statutory Instrument. Further Statutory instruments will follow in 2025 and 2026 to introduce new pre-market requirements including international reliance, and further enhancements to the regulations.

What does it mean to you?

If you are placing medical devices, including in vitro diagnostic (IVD) devices and active implantable medical devices, on the Great Britain market, it is crucial to familiarize yourself with the new statutory instrument and understand its implications for your business. Begin implementing the requirements of this SI well ahead of its effective date, 16 June 2025, to ensure compliance.