Why Early Feasibility Studies Matter for EU Innovation
The European Commission’s recent Call for Evidence on the future of the MDR and IVDR was more than just another regulatory step, it was a real chance to shape how innovation happens in Europe.
For projects like HEU-EFS, this moment really matters.
Early Feasibility Studies (EFS) are small, early-stage clinical investigations that help researchers and developers explore a device’s safety and performance before large-scale trials. They’re crucial when lab testing alone isn’t enough, think high-risk devices, breakthrough technologies, or solutions tackling unmet medical needs.
But there’s a problem: while EFS aren’t excluded under current EU rules, there’s no clear, harmonised pathway to support them. That gap creates uncertainty, slows progress, and makes Europe a tougher place for MedTech innovators to start.
That’s why the HEU-EFS project, funded under the Innovative Health Initiative (IHI), submitted focused recommendations to the European Commission, calling for:
- A clear EU definition of EFS aligned with international standards
- Early dialogue between sponsors, regulators, ethics committees, and expert panels
- Flexibility to run some nonclinical testing in parallel with EFS
- Dedicated templates and tools to simplify EFS applications and reviews
These steps wouldn’t just help researchers, they would speed up patient access to new treatments, lower development risks, and boost Europe’s global standing in medical technology.
The Call for Evidence may have closed on 6 October, but the conversation isn’t over. Let’s keep pushing to make EFS a recognized and supported part of the EU regulatory framework.
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