Regulation (EU) 2017/745- clinical trials application process
After almost 25 years, the law on medical devices has changed. The “old” EU Directives (Medical Device Directive (MDD) 93/42 / EEC and Active Implantable Medical Devices Directive (AIMDD) 90/385 / EEC) were replaced by the Medical Device Regulation (MDR) 2017/475. European Union law considering medical devices has changed from...