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- MDCG issues guidance on clinical evidence for orphan in-vitro diagnosticsThe Medical Device Coordination Group (MDCG) has published new guidance that explains how clinical evidence requirements apply to orphan in-vitro diagnostics (IVDs). The document is intended to he…
- Experts urge streamlined EU AI framework and higher regulatory literacy for healthcare productsExperts speaking at the RAPS AI in Regulatory Conference in Barcelona called for a more streamlined artificial intelligence framework for healthcare products across Europe. They said the current r…