Europe is the world’s second-largest MedTech market after the US, growing at an average annual rate of 5.4% over the last 10 years. However, the sector faces significant headwinds. The implementation of the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) has increased compliance complexity, particularly affecting smaller companies due to extensive documentation and data requirements. As a result, Europe is becoming less attractive for new product launches than the US.
Post-pandemic supply…
