The UK government is set to introduce new, strengthened Post-Market Surveillance (PMS) requirements for medical devices, emphasizing patient safety and transparency. These changes, expected to come into force in mid-2025, are part of a broader commitment to a safer, more efficient medical device regulation regime.
The upcoming PMS requirements will establish a robust framework to monitor device safety after entering the market. This proactive approach aims to identify potential safety issues earlier, enabling manufacturers to respond promptly and maintain high standards for patient care across the UK.
Objective of the new PMS legislation
The objective of the new PMS statutory instrument (PMS SI) is to prioritize patient safety while ensuring access to reliable medical devices. By refining PMS processes and clarifying manufacturers’ obligations, the legislation aims to build a safer environment for patients and foster a market that continues to attract innovators in medical technology.
The PMS statutory instrument (PMS SI)
The draft PMS SI was laid before Parliament on October 21, 2024, marking a crucial step toward formalized PMS standards in Great Britain. Following a six-month implementation period, the PMS SI is anticipated to take full effect by mid-2025. This draft was initially shared with global stakeholders on the World Trade Organization (WTO) website in July 2023, providing an opportunity for review and feedback.
Key changes in the PMS requirements
The final PMS SI draft includes significant updates to help manufacturers implement a comprehensive PMS system. These updates are designed to harmonize data collection methods, streamline reporting obligations, and improve incident response measures, creating a stronger foundation for post-market device monitoring.
Standardized PMS data collection requirements
The new PMS system mandates specific methods for gathering and recording PMS data, enabling better data quality and consistency across manufacturers. This standardization aims to help regulatory authorities monitor device performance more effectively, paving the way for proactive risk mitigation and a safer environment for patients.
Enhanced incident reporting obligations
Under the revised PMS requirements, manufacturers will face stricter obligations to report serious incidents. This enhanced reporting process will enable faster identification of potential safety issues, allowing for earlier intervention and reduced patient risk.
Requirements for Field Safety Corrective Actions (FSCA)
Manufacturers will be required to assess whether a Field Safety Corrective Action (FSCA) is necessary to mitigate the risk of recurring safety incidents. The new regulations provide clear guidelines on issuing Field Safety Notices (FSN) to better reach patients and users who may be at risk, improving targeted risk communication.
Regular PMS data reviews, especially for implantable devices
The PMS SI imposes more stringent requirements for manufacturers to conduct regular reviews of their PMS data, particularly for implantable devices. These reviews aim to detect early trends or safety signals, supporting manufacturers in addressing potential safety issues before they escalate.
Implementation timeline and guidance for manufacturers
The PMS SI is set for a parliamentary debate and is expected to be enacted by summer 2025. To assist manufacturers in meeting these new obligations, comprehensive guidance will be published ahead of implementation. This guidance will offer step-by-step support, helping manufacturers understand the regulatory changes and adapt their systems accordingly.
Summary
The UK’s strengthened PMS requirements underscore the government’s commitment to patient safety and regulatory clarity for medical devices. By establishing comprehensive post-market monitoring obligations, the PMS SI aligns with global best practices and provides a transparent, structured approach to medical device surveillance.
As these regulations take shape, the UK aims to foster a safer market environment and an attractive landscape for medical device innovation, ensuring that patients across Great Britain continue to benefit from advancements in medical technology.
Link to the document:
