SOP/Template

EU MDR Implementation Toolkit: Requirements and Checklist

The 16th Annual Product Complaints Congress for Life Sciences featured the session "Best Practices for Complying with the EU Medical Device Regulation" by Sharon Perez of Novacure. The session identified the major changes in the EU MDR, including UDI, post-market surveillance, clinical evaluation and eudamed. It also discussed how other EU standards and guidelines, including MEDDEV 2.7.1 and EN ISO 13485:2016, intersect with the EU MDR. 

You can download the session presentation here. 

In order for prepare for EU MDR implementation, a gap assessment should be performed and an action plan for the EU MDR transition should be in place. From the session at our conference comes the EU Implementation Toolkit to help you prepare for MDR implementation. 

This comprehensive document breaks down: 

  • ISO 13485:2016 Mandatory Documentation
  • Quality System Requirements - Key Sections of the EU MDR
  • EU MDR Post-market Surveillance Requirements
  • EU MDR Essential Requirement Checklist - Annex I General Safety and Performance Requirements

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