We, the undersigned organisations representing healthcare professionals, researchers, innovators and industry across Europe, recognise the growing role that artificial intelligence (AI) can play in improving patient care and supporting the sustainability of healthcare systems.
The current revision of the MDR/IVDR provides a critical opportunity to avoid creating two parallel product-regulatory systems with overlapping and divergent requirements for AI-enabled medical devices and diagnostics.
To make this framework comprehensive and operational, the revised MDR and IVDR should require the European Commission to adopt without undue delay, the necessary measures reflecting the relevant high-risk AI requirements in the General Safety and Performance Requirements of the MDR and IVDR. These measures should be developed transparently and in consultation with patients, healthcare professionals, including clinicians, scientific experts and other relevant stakeholders.