Key Aspects of New EU Medical Devices Regulation (EU 2017/745).
As the new medical devices Regulation (EU) 2017/745 became fully applicable on May 26th, 2021, medical device manufacturers are legally required to ensure that procedures, systems, documentation related to medical devices are in compliance. The Medical Device Regulation (MDR) retain the existing principles and fundamental components of EU Medical Device Directive (MDD) but with significant improvements in each element. […]
