But when should an "app" actually be considered a "medical device", i.e. which functionalities in an app will bring the app within the scope of the medical device legislation?
The legal point of departure is that an app should be considered a medical device, if it is intended for use for diagnosis, prevention, monitoring, treatment or alleviation of illness or disabilities in humans.
In plain words, this means that an app should be considered a medical device, i.e. if it is intended to assist a consumer in diagnosing disease (e.g. an app, which lets the user take a photo of a birth mark and informs the patient of whether the birthmark may develop into birthmark cancer), if the app allows the user to his/her mobile device as a hearing aid, or if an app lets the user monitor his or her blood sugar values for diabetes management.
What happens if our app is classified as a medical device?
If the DHMA should assess that an app, which has previously been marketed as a regular app, is indeed a medical device, this will trigger numerous requirements onto developer (the term "manufacturer" is used in the medical device legislation) and the distributors of the device.
Among these requirements are:
- That the app itself must be CE marked (if the product is not CE marked, the DHMA may prohibit the sale of the app in Denmark). It is worth noting that the affixing of a CE mark to an app will often require a quite substantial (and costly) effort, and often it simply will not be feasible to follow this route (i.e. the app is withdrawn);
- any advertising of the app must comply with the strict requirements set out in the Executive Order on the Advertising etc. of Medical Devices, and by way of example, the manufacturer will be prohibited from making references to serious diseases (e.g cancer, epilepsy or arthritis);
- the manufacturer/distributor will be subject to vigilance requirements (i.e. the duty to monitor, whether the app malfunctions or whether consumers are able to use the app in accordance with the instructions for use); and
- the processing and transfer of a consumer's health data is subject to the data protection legislation, and the manufacturer must e.g. receive an explicit consent from the consumers to process etc. the health data.
The Danish legislation on the promotion etc. of medical devices is very different from the legislation in other European countries, and it cannot be assumed that e.g. promotional measures, which are acceptable in one member state, will be lawful in Denmark. And more importantly, the developer/manufacturer may experience that an app is not deemed to be a medical device in one member state, but that the Danish authorities classify it as a medical device.
It is thus of crucial importance that the developer/manufacturer takes notice of the medical device legislation (and, in particular, the Danish interpretation of the legislation) at a very early stage in the development process.