According to Enrico Perfler, CEO of 1Med SA, a consultancy specializing in regulatory affairs, there is an increasingly evident trend among medical device manufacturers favouring the United States over Europe for conducting clinical investigations. This preference reflects significant differences in regulatory systems and market dynamics, as highlighted during his presentation at the AboutMedicalDevices conference.
Manufacturers’ Choices Based on Company Size
The behaviour of companies varies depending on their size and access to global markets:
- Large multinational manufacturers: Prefer the United States as the primary market for clinical investigations, postponing their entry into Europe.
- Small companies: Without established partnerships in the USA, they continue to operate primarily in Europe for their investigations.
- Investment-backed companies: Choose the United States as the initial market, using data collected overseas to later enter the European market.
Differences Between Regulatory Systems: Europe vs. USA
One of the main reasons behind this trend lies in the structure of regulatory systems:
- Europe: Hosts approximately 50 notified bodies, with fragmented regulations and processes that are often complex and inconsistent among Member States.
- United States: A single regulatory body, the FDA, oversees the entire process, providing greater consistency and predictability for manufacturers.
This regulatory simplicity in the United States makes the approval process more straightforward and appealing for large manufacturers and investors.
Impacts on the IVD Sector
In the field of in vitro diagnostic devices (IVD), the divide between large companies and small businesses is even more pronounced. Well-structured companies can afford to navigate the U.S. regulatory pathway, while smaller companies remain tied to the European system, with fewer resources and limited access to global markets.
Aglatech14 ContenTalkers
Laura Legnani – Marketing Services Manager
