Regulation Changes Calculus for Substance-Based Medical Devices

摘要

In May 2017, the Medical Device Regulation (EU) 2017/745 (MDR) entered into force, replacing the old Medical Device Directive (MDD; 93/42/EEC medical devices). For a time period of 3 years following the entry into force of the MDR, manufacturers could choose to certify their products either under the new MDR or under the old MDD.