MDCG – guidance on AI and digital platforms ⚕️ Pure Clinical

Doctor using futuristic touch interface to access digital health records and medical diagnostics.

Digital platforms and AI-driven medical software: new MDCG guidance on operator responsibilities and MDR/IVDR–AI Act compliance

New MDCG documents clarify the roles of platform operators under MDR/IVDR and the AI Act. As software becomes more complex, responsibilities shift to include post-market monitoring and algorithm accountability. Essential reading for developers, distributors and notified bodies.