The EU Commission has published the fourth update of the Borderline Manual on the classification of medical devices. For software, it brings no fundamental changes compared with the MDR and MDCG 2019-11.
The manual does, however, contain examples that can be relevant for manufacturers:
- App for the prevention of sexually transmitted diseases:
The app described in the example stores STI test results and allows them to be shared with sexual partners via QR code. In the case of positive findings, anonymised warnings are sent within the network and users receive recommendations on prevention, testing and treatment. This does not count as medical device software, as it merely supports the exchange of information between users without addressing individual physiological parameters.
- Medical calculators: the app described in the example calculates medical scores, for instance to decide on anticoagulation in patients with atrial fibrillation. These can be classified as medical device software, even where the calculations are simple, provided the processing serves a medical purpose.
Somewhat counterintuitively, an app that according to the manufacturer’s description serves prevention is not a medical device according to the manual. And this even though it contains a function for assessing the risk of having been infected with an STI.
A simple calculator, by contrast, is classified as a medical device if it has medical formulas of the kind used in everyday clinical practice pre-programmed and these are then used as a basis for decisions on further treatment.
As with other MDCG documents, this manual also points out that it is not legally binding.
Anyone interested can find the full document here: Update – Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 – September 2025