Which regulatory framework for an app-based study for research purposes?


Hello everyone,

I handle clinical trials for a company that develops medical device softwares in Europe and in the US. We're thinking about launching an app-based feasibility study on a non marked version of a software that will ultimately be CE marked & 510(k).

From my understanding this is feasible in the US without particular regulation to put the app on the store. eConstant must be collected and data must be handled following GDPR & HIPAA. IRB approval can be obtained beforehands to publish scientific papers of interests.

In France however, I'm confused about the process. According to the MDCG guide "is my software a medcial device" the research app will not be a MD if it only "stores, archives or communicates" data, which I find a bit vague. In that case, the app would follow the regulation "other health product" and thus Loi JArdé. In the other case (MD) we shall follow MDR regulation.

Regarding all of this, does anyone know a way to launch the research app for research purposes and to collect data aiming for scientific publications without having to obtain ANSM/Ethics approval ? We are willing to conform to the applicable regulations, but also to overcome the timing that they impose on projects.

Thank you by advance for your help


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If it is a SW to obtain 510(k) in the future, don't see why it is not a SW under the MDR, it will just be regulated under the provisions for clinical trial. In addition for EU, need to be careful with GDPR + Privacy Shield 2.0
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