What are early feasibility studies for medical devices?

“Early feasibility study“, alternatively “early feasibility study”, “early benefit assessment” or “early feasibility study”, in English “early feasibility studies” (EFS), are carried out with a very small number of patients, which take place before the large, approval-relevant studies.

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EFS are used when a new or highly innovative medical device (often still a prototype) is to be tested on humans for the first time with the aim of testing at an early stage of development whether the concept fundamentally works technically and clinically and whether the application is practicable.

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Initial data on manageability, basic safety and functionality in everyday clinical practice is being collected, but not already comprehensive evidence of effectiveness or benefit, as in regulatory studies. In most cases, only a few patients are included in order to identify technical problems, unexpected risks or necessary design changes at an early stage, for example.

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USA regulations (FDA)
In the USA, the FDA regulates Early Feasibility Studies (EFS) through the Investigational Device Exemption (IDE) program in accordance with 21 CFR Part 812.
These studies require an abbreviated IDE application with a focus on benefit-risk analysis, a low number of patients (usually <10-20) and early arrangements (pre-submissions).
The EFS program promotes innovation through direct collaboration with sponsors to optimize design and safety early on.

EU regulations
In the EU, there is no direct equivalent to the FDA-EFS program; early feasibility studies fall under MDR (EU 2017/745), Art. 62 (clinical investigations).
For non-CE marked prototypes, they are treated as “non-compliant investigations,” require ethics commission/BE approval and PMCF planning, without a central FDA-like initiative.
Current discussions (including those by the International Organization for Standardization (ISO) aim at harmonised, innovation-friendly framework conditions.

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Could EFS be of interest to you? Feel free to contact us for a no-obligation initial consultation so that we can generate early evidence.

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