European Medical Device Regulation (EU-MDR 2017/745)
The new regulation on medical products, the Medical Device Regulation (MDR) 2017/745 (MDR), which replaces previous guidelines Medical Device Directive (MDD) 93/42/EEC and Active Implantable Medical Devices (AIMD) 90/385/EEC, has entered into force as from 2017. All manufacturers of Class I to III medical devices must familiarize themselves with the new requirements as soon as possible. The regulation has far-reaching implications and affects all classes of medical products
The EU-MDR brings about many changes, including many definitions, reclassifications, new conformity assessment routes, new Notified Body designations, and more. Stricter requirements on the safety of ingredients, on clinical evidence, and on consistency in regulatory compliance. Much more detailed in the essential principles, and above all: no grandfathering!