EU MDR Active Medical Devices

View 7529 EU MDR Active Medical Devices on BEUDAMED, the Better Database on Medical Devices. Active devices are defined under the EU MDR as those that rely on a source of energy other than that generated by the human body, encompassing products from diagnostic imaging and monitoring systems to infusion pumps and implantable stimulators. These devices are subject to conformity assessment routes and detailed technical documentation requirements that scale with their risk classification.

Manufacturers of active medical devices must demonstrate clinical evidence, implement risk management and cybersecurity measures, and meet UDI and post-market surveillance obligations under the EU MDR. Higher-risk active devices typically require notified body involvement for conformity assessment, while lower-risk active devices follow proportionate conformity routes. Use BEUDAMED listings to review device status, manufacturer information, and regulatory compliance indicators for procurement and regulatory checks.