EU MDR Preparedness: Implementing a MIR-Ready Complaint Management Solution

As the EU MDR expands to focus on the entire product lifecycle, postmarket surveillance and reporting will become exponentially more in-depth. The new EU Manufacturing Incident Report (MIR) v 7.2.1 requires comprehensive information, from market distribution data to clinical and failure data, investigation causes, and conclusions. While much of this data will come from ancillary systems within the manufacturing chain, a significant portion will originate directly from your quality management system (QMS).

Navigating EU MDR Preparedness

This webinar shares strategies for efficiently managing postmarket challenges faced by medical device manufacturers marketing devices in the EU. The focus is on implementing a MIR-ready complaint management system as a key component of your QMS for enhanced post-market patient safety.

Key Focus Areas for EU MDR Preparedness

  • Current State of EU MDR Readiness: Review the current state of EU MDR readiness and identify areas for improvement in your organization.
  • Complaint Management System in QMS: Understand how a robust complaint management system plays a crucial role in ensuring post-market patient safety and compliance.
  • Risk-Based Approach and Decision Trees: Leverage a risk-based approach utilizing decision trees to support post-market reportability and streamline the MIR process.
  • MIR Requirements and EUDAMED Rollout: Explore the current MIR requirements and how they will evolve post-EUDAMED rollout, ensuring your system is prepared for future changes.
  • Maximizing Data Accessibility for MIR Submission: Discover strategies for maximizing data accessibility to facilitate efficient MIR form submission.
  • Leveraging UDI Data: Learn how to leverage UDI data to support the MIR form and enhance data accuracy and traceability.
  • Frequently Asked Questions: Address common questions from your peers regarding EU MDR preparedness and complaint management.

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