Summary
Revises EU guidance on when software and apps qualify as medical-device software and how they are classified under the MDR and IVDR, with decision steps and examples covering Rule 11, modules, components, cloud services, and platform contexts.
Healthcare Implications
AI and software manufacturers should use intended purpose and the revised decision framework to determine regulatory status and class, which drives evidence, quality-system, and conformity obligations. Providers can use the classification and supporting documentation as a baseline for procurement and clinical oversight.