Search pages, courses, and articles
Find your medical AI’s EU AI Act classification route in 2 questions. MDR / IVDR drives the Annex I embedded route with integrated notified-body conformity; Annex III(5)(a) covers public-health benefits + emergency dispatch as standalone high-risk. Different deadlines, different documentation burdens.
Sources: AI Act on EUR-Lex + MDR 2017/745 + IVDR 2017/746. Self-assessment, not legal advice.
Medical device classification under MDR (Regulation 2017/745) or IVDR (2017/746) is the gateway test. If the AI's intended purpose is diagnosing, monitoring, treating, alleviating, or preventing disease, it's a medical device, Annex I embedded route. If it analyses in vitro samples (blood, tissue, urine), it's IVD, Annex I embedded via IVDR.
The guide walks the dual MDR + AI Act conformity assessment process, Article 73 + MDR Article 87 twin-clock incident reporting, Article 14 human oversight in clinical settings, and the Article 2(8) research exception.
