EU Medical Devices Regulation (MDR 2017/745) MDR-Art.51: Classification of devices (Article 51 and Annex VIII)

Article 51 + Annex VIII set the risk-based classification system for medical devices into Class I (low risk; e.g. wheelchairs, spectacles), Class IIa (medium risk; e.g. hearing aids, thermometers), Class IIb (medium-high risk; e.g. ventilators, infusion pumps), Class III (high risk; e.g. implants, life-supporting devices, drug-delivery devices, contraceptives, breast implants). Annex VIII has 22 classification rules + special-rule provisions. The classification drives the conformity assessment route under Article 52.