Strategies for Post-Market Surveillance Compliance: Optimal Methods and Regulatory Adherence in MDR
Under the EU Medical Device Regulation (MDR) 2017/745, manufacturers are required to maintain a robust Post-Market Surveillance System (PMS System) and a Post-Market Surveillance Plan (PMS Plan) for devices placed on the EU market. This system is crucial for continuously monitoring the safety and effectiveness of medical devices after market placement.
### General PMS Requirements Under EU MDR
The PMS System enables the identification of trends, early detection of risks, and timely corrective actions such as safety notices. Activities under PMS include vigilance reporting of incidents, clinical follow-up studies, user feedback evaluation, and risk-benefit reassessments. Handling surveillance data must comply with GDPR regarding data protection and privacy.
### PSUR and PMSR Specific Guidelines by Device Class
For higher-risk devices (Class IIa, IIb, III), manufacturers are obligated to prepare a Periodic Safety Update Report (PSUR) summarising the results of PMS activities, including safety data, clinical evaluation updates, and corrective actions taken. The first PSUR must be produced within two years after the device is marketed or put into service. PSUR updates are generally required at least every one to two years, depending on the device classification and risk profile, with exact frequency specified in the PMS plan as per MDR requirements.
On the other hand, for lower-risk devices (Class I, including sterile and measuring functions), manufacturers typically submit a Post-Market Surveillance Report (PMSR), which summarises PMS findings and any resulting corrective actions. The first PMSR and periodic updates are to be prepared at least every three years, or as specified in the PMS plan.
### Additional Key Points
- Devices can be grouped under a single PSUR based on similar risk and performance profiles, with the highest risk device setting the reporting schedule. - Manufacturers must provide PSURs or PMSRs to competent authorities on request within three working days. - Surveillance findings from PSURs/PMSRs feed into the vigilance system, prompting reporting of incidents within 15 days and enabling risk mitigation strategies like Field Safety Notices. - The MHRA guidance on PMSR and PSUR preparation parallels EU MDR and can assist manufacturers with compliance.
In summary, medical device manufacturers must conform to the EU MDR’s enhanced post-market surveillance obligations to safeguard patient safety and device performance throughout the product lifecycle. A robust and structured PMSR plan should be in place, outlining PMS data collection and analysis procedures and reporting timelines. Post-Market Surveillance Reports (PMSR) are essential for monitoring the performance of devices after they have been approved for sale. Compliance with PMSR and PSUR requirements under the MDR is essential for ensuring the safety and effectiveness of medical devices on the market.
- Under the EU Medical Device Regulation (MDR), a Post-Market Surveillance System (PMS System) is mandatory for medical devices placed on the EU market, enabling the ongoing monitoring of medical devices' safety and effectiveness.
- Manufacturers of higher-risk medical devices are required to prepare a Periodic Safety Update Report (PSUR) detailing PMS activities, safety data, clinical evaluation updates, and corrective actions, with the first PSUR due within two years of market placement.
- For lower-risk medical devices, Post-Market Surveillance Reports (PMSR) summarizing PMS findings and corrective actions are essential, with the first PMSR and periodic updates due at least every three years.
- Additionally, adhering to post-market surveillance requirements under the MDR, such as data protection, timely reporting of incidents, and responding to competent authority requests, is vital for maintaining quality management in the health-and-wellness sector, as well as ensuring the safety and effectiveness of medical devices during therapies and treatments for various medical-conditions.
