When are health apps medical devices? - two new sets of guidelines

In new guidelines the Danish Medicines Agency has provided a detailed account of when a health app is a medical device and as a consequence must fulfil the statutory requirements applying to medical devices, including risk classification and CE marking.

Apps having a medical purpose and specifically meant for diagnostic or therapeutic purposes are medical devices. In the guidelines the Danish Medicines Agency clarifies that the non-exhaustive list below of words in the manufac-turer's description of the purpose of the app in question increases the likelihood of the app being a medical device; "alerts, analyses, calculates, diagnoses, interprets, generates, controls, converts, monitors or measures".

The Danish Medicines Agency also points out that apps which are "decision support apps" (for instance in relation to the calculation of dosage, tracing of symptoms or clinician guidelines), di-agnosing apps and monitoring/supervising apps will typically be medical devices. But an app helping users to remember to take their medicine is not a medical device.

The Medicines Agency has also prepared a decision model/decision tree to make it easier to assess whether the app in question is a medical advice.

The guidelines are published together with guidelines to users about health apps and software as medical devices.

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