Case Study | Project with MindAhead UG
The digital health startup MindAhead faced the challenge of declaring self-conformity for its risk class 1 product while meeting all regulatory requirements for safety and performance. In addition, the upcoming DiGA study also needed to be planned in compliance with the regulations. To this end, the team drew on the expertise of the MII. Prior to that, MindAhead – along with 2 more startups – had succeeded in obtaining BioMan4R2 funding with the help of the MII. Public funding programs like this offer founders the necessary financial resources to work with external experts like the MII.
Our solution
The startup MindAhead has developed a therapeutic app for people with mild cognitive impairment and mild dementia, which falls under risk class I according to the MDR. Even if this means that no Notified Body has to be involved in the conformity assessment, as a distributor of such a product, you still have to ensure its safety and performance. The MII’s consultation therefore included a regulatory clarification of the product’s Technical Documentation (TD), which the startup had already drawn up largely independently. In particular, the clinical evaluation and risk management files were reviewed to ensure that there was actually no risk to patients in the upcoming clinical study and that the product was safe and effective. The upcoming clinical study served as proof of benefit for the listing in the DiGA directory. The study protocol was also reviewed for regulatory compliance by the MII expert for C3 Clinical Studies, Dr. Henrike Stutzki, and valuable tips were provided for the planning of the study.
Our formats and methods
- Flexible ad-hoc consulting appointments with an MII consultant
- Document review: clinical evaluation, risk management file, study protocol
- Feedback meetings to process the review results
- Briefing for a BfArM meeting on the upcoming DiGA study
The result
The concrete feedback and the needs-based consultation appointments with the MII helped the MindAhead team to gain more confidence about the regulatory conformity of their product and to better understand the bigger picture of the regulatory framework. With the support of the MII, the startup was able to finalize its TD and achieve the desired CE marking more quickly. In addition, a positive ethics vote was obtained for conducting the planned study and the team was able to start the clinical study with the necessary certainty.
“Thanks to the excellent advice from the MII, we were not only able to ensure the regulatory conformity of our therapeutic app, but also achieve the desired CE marking more quickly. We are very grateful for the great cooperation.”
MindAhead develops digital solutions for the dementia sector. These include a digital therapy that helps people with early-stage dementia to adapt their lifestyle and slow down the progression of the disease. The startup has also developed an app that serves as a screening tool for the early detection of dementia.
