MDR/IVDR for AI Medical Devices

Conform AI medical devices to EU MDR (Regulation 2017/745) and IVDR (Regulation 2017/746). Learn classification rules under MDR Annex VIII (where AI sits), GSPR (general safety and performance requirements) mapping, clinical evaluation and post-market clinical follow-up (PMCF), the relationship between MDR/IVDR and the AI Act (high-risk AI in medical devices), and the dual-marking and combined notified-body assessment that is now required.