According to the EU MDR, whether an app is a medical device or a wellness product depends on the intended purpose. If the app is used to diagnose or treat diseases, it is a medical device. See definition “medical device”.
An app is a medical device, if the user should use it in human being for any of the following
- “diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
- investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
- providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
The following products shall also be deemed to be medical devices:
- devices for the control or support of conception;
- products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point.”
(Art. 2 (1), EU MDR)« Back to Glossary Index