What is Regulation EU 2017/745 on medical devices (MDR)?
Published in May 2017, the MDR is formally the definitive regulation governing the marketing of medical devices within the European Economic Area (EEA).
The regulation is based on a lifecycle approach and replaces both the Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC and the Medical Devices Directive (MDD) 93/422/EEC. The MDR strengthened regulatory emphasis on clinical data and clinical evaluations while elaborating guidance pertaining to post-market evaluations and vigilance efforts.