Directive 93/42/EEC set out the legal basis for introducing a medical device into the European Economic Area. Individual Member States are responsible for implementing this Directive in relevant national legislation. On May 25, 2017, the new regulation (EU) 2017/745 on medical devices came into force. This is also known as the Medical Device Regulation (MDR) and is valid without transposition into national laws. With a transitional period of 3 years, it will replace the Medical Devices Directive 93/42/EEC.
