The European MedTech sector comprises approx. 27.000 companies, 95% of which are SMEs. These companies need to demonstrate not only safety and performance over the entire life cycle of a product but also, tangible benefits for the patients and the healthcare system.

Healthcare system in EU has to deal with two main and growing problems: large variation in patient outcomes and continuous increase of costsNew regulation EU 2017/745:demonstrate safety and performance through clinical evaluation of the product's entire life cycleReimbursement approval:Demonstrate benefit for patients and health systems

As a highly innovative sector, with an average lifecycle per product of 18-24 months, this scenario poses several challenges, especially for high-tech SMEs.

Highly innovative sector
18-24 months Lifecycle
27.000 companies 95% are SMEs