EU-MDR and IVDR Roadmap Published

The Competent Authorities for Medical Devices, CAMD, Implementation Taskforce published the Medical Devices Regulation/In-vitro Diagnostics Regulation (MDR/IVDR) Roadmap. You can download the roadmap from

The contents include:

  • Clinical Evaluation & Clinical Investigation (MD)
  • Performance Evaluation & Performance Studies (IVD)
  • Scope & Classification
  • Notified Bodies & Conformity Assessment
  • Post-Market Surveillance & Vigilance for both MD and IVD
  • Eudamed & UDI
  • Market Surveillance
  • IVD-specific Issues
  • Over-arching & Cross-cutting Priorities

In addition, there are two documents that include frequently asked questions.

For the EU-MDR, go to

For the EU-IVDR go to