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).