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Medical devices has a fundamental role in saving lives by providing innovative healthcare solutions for the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease.
Europe is a second largest market in the world behind the USA with 27% of the world market revenue. The market size was estimated at roughly € 120 billion in 2018.
To keep up with advances in science and technology and to ensure better protection of public health and patient safety were adopted, On 5 April 2017, 2 new Regulations on medical devices and in vitro diagnostic medical devices establishing a modernized and more robust EU legislative framework. These 2 new Regulations (Regulation (EU) 2017/745 and Regulation (EU) 2017/746 are replacing the 3 existing Directives after a transition period (until 2022).
In addition, ISO 13485 is increasingly required, or at least beneficial as a standard of the Quality Management System accepted as the basis for CE Marking under European directives.
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