Is your solution a medical device?
If you do not know if your solution is a medical device, here is a reference to a digital tool that helps you to understand better different aspects of medical device regulations https://www.reg-metrics.com
RegMetrics digital tool is developed by the Natural Interaction Lab (NIL) within the Department of Engineering Science at the University of Oxford. This work is funded by Engineering and Physical Sciences Research Council (EPSRC) and European Institute for Innovation & Technology (EIT) Health and Innovate UK.
We encourage you to investigate it more and then continue with the toolkit process.