Dr. Schumacher

The Medical Device Regulation (EU) 2017/745 (MDR) entered into force in May 2017. Dr. Schumacher, as a manufacturer of medical devices, has been hard at work preparing for the new regulations, and all the necessary measures to implement the wide-ranging requirements have been initiated. The MDR replaces the existing Medical Device Directive (MDD) and the Active Implantable Medical Device Directive (AIMDD). Its aim is to increase the safety of medical devices, to better protect patients, and to provide greater transparency and traceability of medical devices.