The new IVDR places greater emphasis on post-market surveillance (PMS) with the aim of continuously monitoring the quality, performance, and safety of a device throughout its entire lifecycle. PMS enables manufacturers to quickly identify issues with the design, manufacture, or use of the device and ultimately enhance patient safety.
Under the new regulation, manufacturers need to develop a PMS plan and report as part of their technical documentation.
The PMS plan should include:
- Proactive and systematic process for collecting data related to serious incidents, product trends, customer complaints, user feedback, etc.
- Effective and appropriate methods to assess collected data
- Indicators and threshold values for assessing risk-benefit and effective risk management
- Methods and tools for investigating complaints and other market-related information gathered in the field
- Methods and protocols to manage events subject to the trend report, as outlined in Article 83
- Protocols for communicating with competent authorities, notified bodies, economic operators, and users
- Reference to procedures that fulfill manufacturer obligations for the PMS system, PMS plan, and periodic safety update report (PSUR)
- Processes and procedures for implementing corrective actions
- Tools to effectively trace potentially defective products
The PMS reporting requirements will depend on the classification of device.
Arena QMS Tip:
Leverage the Arena quality templates to help formulate your post-market surveillance plan and reports. Once created, they are linked to your product record and show the history of any changes that are made. Documents can be easily exported and included with your technical file.
Post-Market Surveillance Report (PMSR)
Post-market surveillance reports (PMSRs) are required for Class A and B devices. The PMSR should provide a summary of results and conclusions about post-market surveillance data defined in the PMS plan, as well as the rationale and description of any corrective or preventive actions taken. The report should be updated when necessary and made available to the notified body and competent authorities upon request.
Periodic Safety Update Report (PSUR)
Periodic safety update reports (PSURs) are required for Class C and D devices. In addition to the information contained in the post-market surveillance report, the PSUR should also include key findings from the postmarket performance follow-up (PMPF), conclusion of the benefit/risk determination, and data on sales volumes, user populations, and frequency of use. The report must be updated annually (at minimum) and made available to the notified body and competent authorities.