The medical devices and in vitro diagnostic (IVD) medical devices sector is essential for the provision of healthcare to citizens and is an important player in both the European and global economy. They save lives by providing innovative healthcare solutions for disease diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation.
Europe is at the forefront and produces more than 500,000 medical devices. The EU has set up a legal and regulatoryframeworkto facilitate the growth of this sector and to better protect citizens.
The EU has recently adopted the new regulation on medical devices. Entry into force: on May 26, 2021. For in vitro diagnoses: on May 26, 2022.