EU In Vitro Diagnostic Medical Devices Regulation (IVDR) IVDR-Art.47: Classification of devices (Article 47 and Annex VIII)

Article 47 + Annex VIII set the risk-based classification system for IVDs into Class A (low risk; e.g. specimen receptacles, buffers), Class B (moderate risk; e.g. pregnancy tests, cholesterol), Class C (high individual + moderate public-health risk; e.g. companion diagnostics, blood gas), Class D (high individual + high public-health risk; e.g. HIV, transfusion-transmissible infections). Annex VIII has 7 classification rules + special-rule provisions for self-tests + near-patient testing. The classification drives the conformity-assessment route under Article 48.