The new MDR 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 regulations, manufacturers need to develop a PMS plan and report as part of their technical documentation.
The PMS reporting requirements will depend on the classification of the device.
Post-market surveillance reports (PMSRs) are required for Class I medical 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 must be updated/produced once every three years (at minimum).
Periodic safety update reports (PSURs) are required for Class IIa, IIb, and III devices. In addition to the information contained in the post-market surveillance report, the PSUR should also include key findings from the postmarket clinical follow-up (PMCF), conclusion of the benefit/risk determination, and data on sales volumes, user populations, and frequency of use. The report must be updated every two years (at minimum) for Class IIa devices and at least once a year for Class IIb and Class III devices.
Section 2: Key Changes Under New MDR
Economic Operator Roles and Responsibilities
Clinical Evaluations and Post-Market Clinical Follow-up (PMCF)
Post-Market Surveillance (PMS)
European Database for Medical Devices (EUDAMED)
Serious Incident and Corrective Action Reporting
Section 3: Quality Management System (QMS) Requirements
Section 4: Steps for a Successful EU MDR Implementation
Section 5: MDR Implementation Checklist
Section 7: Appendix - Frequently Asked Questions & MDR Quick Guide