UK Updates Post-Market Surveillance Requirements for Medical Devices

The Medicines and Healthcare products Regulatory Agency (MHRA) has released updated guidance on post-market surveillance (PMS) requirements for medical devices in Great Britain. The document, titled "The Medical Devices Post-Market Surveillance Requirements (Amendment) Great Britain Regulations 2024: Guidance on Implementation," provides clarification and details on fulfilling the regulatory obligations for manufacturers.

The updated guidance likely addresses changes and amendments to existing regulations, ensuring a more robust and responsive PMS system. Medical device manufacturers should carefully review the document to understand the specific requirements and ensure compliance. Key areas likely covered in the guidance include:

• Reporting requirements: Updated timelines or procedures for reporting adverse events or incidents related to medical devices.
• Data collection and analysis: Expectations for collecting and analyzing post-market data to identify potential safety or performance issues.
• Corrective and preventive actions (CAPA): Guidelines for implementing CAPA plans to address identified issues and prevent recurrence.
• Periodic safety update reports (PSURs): Requirements for preparing and submitting PSURs to demonstrate ongoing monitoring of device safety and performance.

Manufacturers placing medical devices on the Great Britain market should prioritize a thorough review of this guidance to ensure their PMS systems align with the latest regulatory expectations. Non-compliance can lead to penalties and market access restrictions.

If any individual devices are placed on the GB market after 16 June 2025, all applicable requirements must be fulfilled.

For more detailed information, refer to the official MHRA guidance document available on the UK government website.