What is the EU MDR?

The Medical Device Regulation, Regulation (EU) 2017/745, is the primary law governing medical devices in the European Union. It applied from 26 May 2021, replacing the earlier Medical Device Directive and Active Implantable Medical Device Directive. The MDR tightened requirements across the board: stricter clinical evidence, reclassification of many devices into higher risk classes, expanded roles for notified bodies, unique device identification, and a central database called EUDAMED. Manufacturers must demonstrate conformity through clinical evaluation and post-market surveillance, and appoint a person responsible for regulatory compliance. Software with a medical purpose falls within scope and is classified according to the harm its information can cause. Transitional provisions have been extended several times to ease notified body capacity constraints, so the effective dates for legacy devices depend on their risk class and certificate status.