Tag Archives: medical device regulation mdr

Manufacturers of medical devices will soon face major changes in EU regulation decades ago to manage EU market access. MDR replaces the current EU Medical Device Directive (93/42 / EEC) and the EU Transplant-able Medical Device Directive (90/385 / EEC).The Medical Device Regulations were formally released on May 5, 2017, and it came into effectContinue reading “EU Medical Device Regulation: Be Confident of Medical Device Market Approval”