Postmarket surveillance and reporting under EU MDR will be exponentially more in-depth as it expands to focus on the entire life cycle of the product. The new EU Manufacturing Incident Report (MIR) v 7.2.1 requires extensive information, from market distribution data to clinical and detailed failure data, to cause investigation and conclusions. While much of the information submitted to EUDAMED will come from ancillary systems in the manufacturing chain, a significant portion of data will come directly from your quality management system (QMS).

This webinar shares strategies for efficiently managing postmarket challenges faced by medical device manufacturers marketing devices in the EU.

Key focus areas include:

• Review the current state of EU MDR readiness
• The complaint management system as a key process in QMS for post-market patient safety
• Leveraging a risk-based approach utilizing decision trees to support post-market reportability
• MIR requirements today and post-EUDAMED rollout
• Maximizing data accessibility for MIR form submission
• Leveraging UDI data to support the MIR form
• Frequently asked questions by your peers

Watch a brief demonstration of how a quality management system can populate MIRs for submission with data extracted from complaint and UDI records.