FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

CAMD Releases MDR/IVDR Implementation Roadmap

Nov. 17, 2017

The EU’s Competent Authorities for Medical Devices (CAMD) — the umbrella group through which the EU’s national competent authorities work to enhance the single market for medical devices — released a new roadmap with a priority list of areas of focus for implementing the new European MDR/IVDR regulations.

The priorities include:

  • Clinical evaluation and clinical investigation;
  • Performance evaluation and performance studies;
  • Scope and classification;
  • Notified bodies and conformity assessment;
  • Post-market surveillance and vigilance for both MD and IVD;
  • Eudamed and UDI;
  • Market surveillance; and
  • IVD-specific issues.

Some of the actions categorized as high priorities include developing guidance on equivalence, well-established technologies and clinical evidence, classification guidance for IVDs, and industry guidelines for assigning unique device identifies (UDIs).

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