The MDR Hurdle for Startups and Innovation – And Strategies To Overcome It

Description: Start-Up companies with innovative medical solutions face significant challenges in navigating the complex process of bringing their ideas to market, particularly in the context of the requirements of the Medical Devices Regulation (MDR). However, gaining efficiency in achieving regulatory compliance to enable early market access for innovative products isn’t only important for new players but also for established companies.

Combining insights from real-life situations and case studies, this session will highlight specific strategies adapted to the particular needs of startups and how these can be successfully applied, building bridges to benefit established players. These include creative testing methods, lean approaches, and increased digitalisation, as well as specific lessons learned from an approach of a pharmaceutical company's spin-off project aimed at helping early-stage startups achieve compliance more efficiently.

Combined, this leads to faster market access for innovative healthcare solutions in Europe.