EU MDR / IVDR Regulation

By now, you’ve likely encountered discussions surrounding the EU Medical Device Regulation (EU MDR) and the EU In-Vitro Diagnostic Regulation (EU IVDR). These regulations represent a significant shift in the European regulatory framework, introducing more rigorous requirements for medical devices and in-vitro diagnostics to ensure patient safety, product transparency, and post-market surveillance.

The EU MDR, effective May 26, 2021, and the EU IVDR, effective May 26, 2022, have fundamentally reshaped the compliance landscape. All manufacturers wishing to place their devices on the European market must now fully adhere to these updated regulations.

Key Changes Under the EU MDR and IVDR:

1. Increased Focus on Clinical Evidence:
   • Both MDR and IVDR demand robust clinical data to demonstrate product safety and performance.
   • Manufacturers must provide clinical evaluation reports (CERs) for medical devices and performance evaluation reports (PERs) for IVDs.
2. Risk Management Alignment with Labeling:
   • Residual risks identified in your Risk Management Profile must now be explicitly reflected in your product’s labeling.
   • This ensures that end-users are informed about potential risks and mitigations associated with the product.
3. Post-Market Surveillance (PMS) and Vigilance:
   • Manufacturers are required to maintain proactive PMS systems and submit Periodic Safety Update Reports (PSURs).
   • Vigilance reporting timelines have been tightened, demanding faster responses to adverse events.
4. Unique Device Identification (UDI):
   • Devices must now have Unique Device Identifiers (UDI) for better traceability throughout the supply chain.
5. More Stringent Requirements for Technical Documentation:
   • Technical files must now be far more detailed, structured, and regularly updated.
6. Classification Changes for IVDs:
   • Under IVDR, many in-vitro diagnostic devices have been reclassified into higher-risk categories, requiring Notified Body involvement where it wasn’t previously necessary.