The European Commission recently published a proposal that could be highly relevant for MedTech startups. It introduces a new incentive to boost innovation and startups: the ‘EU Inc.’
It is a new way to establish a company that is recognized across the EU. It can be done in a day, and the costs are around 100€ for all companies, regardless of where you are based. For some countries, the difference might not be that big. However, in some countries, the costs and timelines for setting up and maintaining a company are significantly higher, so this new form is making a difference. For startups, especially in competitive sectors like MedTech, this could significantly improve access to talent by making stock options and cross-border hiring more practical. Once the company grows and wants to expand, the new structure makes this significantly easier, as EU Inc. is accepted in all EU countries.
This new company registration form demonstrates the EU’s effort to invest in innovation and make it easier to bring innovative products to market.
From a medtech perspective, the main challenges remain unchanged. Companies still need to comply with the Medical Device Regulation (MDR), which applies across the EU but remains complex to implement.
In addition, reimbursement is still handled at the national level. This is a problem for medical technology startups because they need to plan for each country they want to enter the market in and make money.
In summary, EU Inc. simplifies company structure and scaling, especially during the initial phases of company setup and early growth, but it does not reduce regulatory timelines or the complexity of European healthcare systems.