Current Edition

Clinical Requirements under EU MDR: Understanding the Changes

The European Medical Device Regulation 2017/745 (MDR) entered into force on 26th May 2017, bringing together requirements from the Medical Devices Directive (MDD, 93/42/EEC), Active Implantable Medical Devices Directive (AIMDD, 90/385/EEC) and a variety of European guidance documents into a single regulation. Dr. Amie Smirthwaite at Maetrics evaluates the clinical requirements under the EU MDR while outlining the changes that have been made.