Post-market surveillance (PMS) is a comprehensive and ongoing process that involves monitoring and evaluating medical devices after they have been placed on the market to ensure their continued safety, effectiveness, and quality. Both in the United Kingdom (UK) and the European Union (EU), robust post-market surveillance practices are crucial to safeguarding patient health and maintaining the integrity of the healthcare system. Here are the key aspects involved in post-market surveillance in both regions:
PMS in the United Kingdom (UK):
Regulatory Oversight:
- In the UK, post-market surveillance activities for medical devices are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA). Manufacturers are required to comply with MHRA guidelines and regulations to ensure the safety and performance of their devices.
Post-Market Surveillance System:
- Manufacturers must establish and maintain a post-market surveillance system to collect and evaluate data on their devices’ performance and safety in real-world settings. This system includes procedures for monitoring adverse events, customer feedback, and other relevant information.
Adverse Event Reporting:
- Manufacturers, healthcare professionals, and users are obligated to report any adverse events, product-related issues, or incidents related to medical devices to the MHRA promptly. Timely reporting is crucial for identifying potential risks and taking necessary corrective actions.
Post-Market Surveillance Reports (PMSRs):
- Manufacturers of Class I devices are required to maintain Post Market Surveillance Reports (PMSRs). These reports contain information on the device’s performance, adverse events, and any corrective actions taken.
- Periodic Safety Update Reports (PSURs):
- Manufacturers of Class IIa, Class IIb, and Class III devices are required to produce Periodic Safety Update Reports (PSURs). These reports provide a comprehensive overview of the device’s safety and performance data collected during specific periods, typically annually.
PMS in the European Union (EU):
Regulatory Framework:
- In the EU, post-market surveillance is governed by the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR). These regulations establish rigorous requirements for post-market surveillance activities to enhance patient safety and ensure device effectiveness.
Post-Market Surveillance System:
- Manufacturers must establish and maintain a post-market surveillance system in compliance with the MDR/IVDR. This system includes procedures for systematic data collection, trend analysis, and risk assessment to monitor the device’s performance and safety throughout its lifecycle.
Periodic Safety Update Reports (PSURs):
- Manufacturers of Class IIa, Class IIb, and Class III devices are required to submit Periodic Safety Update Reports (PSURs) to regulatory authorities via EUDAMED. These reports provide a comprehensive overview of the device’s safety and performance data collected during specific periods, typically annually.
Vigilance System:
- The EU operates a vigilance system, which involves the continuous collection, evaluation, and reporting of adverse events and incidents related to medical devices. Manufacturers, authorized representatives, and healthcare professionals must report any adverse events to regulatory authorities, allowing for prompt regulatory action if necessary.
Market Surveillance Authorities:
- EU member states designate market surveillance authorities responsible for ensuring compliance with post-market surveillance requirements. These authorities conduct audits, inspections, and sampling to verify the conformity of devices in the market.
How can Patient Guard Help?
Patient Guard has extensive experience with Medical Device PSM and vigilance requirements both in the UK and the EU. We can assist you in writing your PMS plans, PMSRs and PSURs, assistance with communicating with the Regulatory Authorities in relation to adverse event reporting and if needed providing support and advice Field Safety Corrective Actions (FSCA) and Field Safety Notices (FSN).
We also can assist you with another area of PMS in form of PMCF activities. Contact us to day to find out more about our PMS and Vigilance support.
