Diagnostics: Purpose of my service

Attention, the suggested results correspond to the answers checked. They provide an initial insight but they are no substitute for the personalised and in-depth analysis that a legal or regulatory expert can provide

Does the service provide treatment for the individual benefit of a patient?

Practical guide

You don't know how to answer, the keys for choosing

You don't know how to answer, the keys for choosing

Software that is not considered to be for the benefit of individual patients is, for example, software that is intended only to

  • aggregate the data of the population,
  • provide generic diagnostic or treatment recommendations (not addressed to individual patients),
  • produce scientific literature, medical atlases
  • or software intended solely for epidemiological studies or registries.


  • An algorithm that analyses Facebook posts in a given region to predict a flu epidemic is not a medical device because it does not benefit an individual patient.
  • On the other hand, an algorithm that analyses a person's Facebook posts to establish a diagnosis (e.g. diabetes or depression) is a medical device because it has a diagnostic purpose for a specific patient and uses input data (Facebook posts) to create new medical information (risk of developing diabetes).