Imagine trying to bake a complex cake for a competition without knowing if the oven works or if the guests like the flavor. Right now, European medical companies often wait too long to test their inventions on a small group of people, which is risky and slow. This initiative creates a clear, shared rulebook so companies can test early and fix mistakes before spending millions on final trials.
Medical device companies in the EU lack a standardized way to conduct early clinical tests, making the path to market authorization risky and unpredictable compared to the US FDA process.
A standard Clinical Investigation Plan template, two databases (PMAP-DB and EFS-DB), and an open access online portal for best practices.
If you are a health technology developer dealing with high failure rates in late-stage clinical trials — this project developed a harmonized methodology that allows you to gather data early to inform your business case.
If you are a CRO dealing with inconsistent requirements across different EU countries — this project developed a standard Clinical Investigation Plan template that streamlines the setup of early studies.
If you are a software startup dealing with the complexity of the Medical Devices Regulation — this project developed an open access online portal with best practices to guide your early evidence generation.
Based on available project data, the project aims to inform business cases early through Early Feasibility Studies, which helps avoid costly failures in later stages of development.
Yes, the project specifically targets the EU single market competitiveness by creating a harmonized approach recognized across 13 participating countries.
Based on available project data, the project is developing a sustainable, open access online portal for the methodological tools and best practices.
It aligns early testing with the Medical Devices Regulation and Health Technology Assessment regulation to ensure clinical evidence is generated throughout the product lifecycle.
The project runs from 2023-10-01 to 2027-09-30, with pilot use-cases currently being prepared for implementation.
The consortium is heavily industry-driven, with a 67% industry ratio comprising 26 companies, including 6 major private firms and 5 SMEs. This high level of commercial involvement, paired with 39 partners across 13 countries, suggests the resulting guidelines will be grounded in practical business needs rather than just academic theory.
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