The Medicines and Healthcare products Regulatory Agency (MHRA) has unveiled comprehensive guidance to assist medical device manufacturers in navigating the upcoming Post-Market Surveillance (PMS) regulation for medical devices in Great Britain.
Set to take effect on June 16, 2025, these pivotal regulations aim to enhance patient safety and streamline compliance for manufacturers. The new PMS regulation introduces several critical requirements:
- Enhanced Data Collection
- Shorter Reporting Timelines
- Summary Reporting
- Clearer Risk Mitigation Obligations
Businesses are urged to adopt the guidance immediately to familiarize themselves with their obligations and prepare for compliance ahead of the June 2025 deadline. This proactive approach is essential to ensure a seamless transition and maintain high safety standards.
Chief Officer and MedTech Regulatory Reform Lead at the MHRA, Laura Squire, commented:
“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.
“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.”
The regulations will encompass all medical devices in GB, including in vitro diagnostic (IVD) devices and active implantable medical devices. However, the PMS requirements will vary based on the device's risk level. The MHRA's guidance provides detailed information to support manufacturers in adhering to these nuanced requirements, ensuring their devices meet the necessary safety and performance standards.
The MHRA encourages businesses to provide feedback on the guidance through Trade Associations. This collaborative approach will help identify areas for enhancement before the regulations come into force. The agency remains committed to updating the guidance as necessary to reflect industry insights and evolving best practices.
The MHRA's consultation on the 'Future Regulation of Medical Devices in the UK' in 2021, in response to the Independent Medicines and Medical Devices Safety (IMMDS) review, highlighted strong support for robust PMS requirements. This regulation aligns with international standards and sets the stage for future measures, such as international reliance, allowing patients to benefit from medical devices approved in other countries more quickly.
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