EU MDR Class IIb Medical Devices

View 10000 EU MDR Class IIb Medical Devices on BEUDAMED, the Better Database on Medical Devices. Class IIb devices are medium-to-high risk products such as ventilators, infusion pumps, implantable neurological stimulators, and certain long-term external therapeutic devices. These devices normally require notified body involvement for conformity assessment and more comprehensive technical documentation than lower-risk classes.

Manufacturers of Class IIb devices must provide robust clinical evaluation, implement post-market surveillance, and apply unique device identification (UDI) for traceability. Notified bodies assess quality management systems and technical files before CE marking, and ongoing vigilance reporting is mandatory under the EU MDR. BEUDAMED helps regulators, manufacturers, and healthcare professionals access regulatory status, certificates, and market information for Class IIb devices.