Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices 1 and Regulation (EU) 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices 2 were adopted on 5 April 2017 and entered into force on 25 May 2017. Regulation (EU) 2017/745 applies since 26 May 2021 3 . Regulation (EU) 2017/746 will apply from 26 May 2022 4 .
Medical devices and in vitro diagnostic medical devices have a fundamental role in saving lives by providing healthcare solutions for the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease. Regulations (EU) 2017/745 and (EU) 2017/746 aim to provide a robust, transparent and sustainable regulatory framework in order to ensure a high level of safety and performance of medical devices and in vitro diagnostic medical devices, while supporting innovation…
