Medical Device Regulation (MDR) infographic and timeline

The Medical Device Regulation (MDR) is the new regulation that replaces the Medical Device Directive (MDD).

Key changes

  • Wider scope of regulated medical devices
  • More stringent clinical evidence and documentation
  • Increased focus on identification and traceability
  • Definition of common specifications
  • Unannounced factory audits
  • Increased Notified Body authority and/or involvement
  • More rigorous vigilance and market surveillance
  • At least one person responsible for regulatory compliance
Click on the image below to see Lloyd's Register infographic of MDR key changes and key dates timeline.