On 7 March 2017, the European Council officially approved the New Regulations on Medical Devices and IVD devices.
By the end of April they will be officially published after their approval by the European Parliament, and then they enter into force by the end of May.
The final version of the New Regulations published in February 2017, entails numerous changes for both operators in medical sector and the competent Authorities, starting from the actual definition of medical device to the creation of the new EUDAMED database.
In order to facilitate the adaptation of the parties involved in the New Regulation, the European Council provided a transitional period of 3 years for the Medical Devices sector (by 2020) and 5 years for the IVD devices (2022).
For more information: