Guidance for consumers on health apps and software as medical devices
This guidance is aimed at consumers who use health apps and software that are medical devices. It offers guidance on how to tell if a health app is a medical device and how you should go about them.
Mobile platforms like smartphones and tablets have become widespread among users. They offer a line of functionality such as high availability, transfer and storage of personal data, camera function and much more. Software like this is increasingly being used in apps with a health purpose.
There has been a large increase in the development of health apps for consumers and patient groups with all sorts of purposes and functionality. The purpose of an app could for example be to serve as an aid to monitor disease, health, exercise, lifestyle etc. The vast majority in this group of health apps are not medical devices and therefore are not CE marked.
Medical device legislation
Medical devices are products used to diagnose, prevent, alleviate or treat disease, disability, injury etc. The definition in the Danish Executive Order no. 1263 of 15 December 2008 on Medical Devices includes software and apps that have a medical purpose and are intended to be used for diagnostic or therapeutic purposes.
Medical devices are not to be authorised by the Danish Medicines Agency, but must be CE marked before placement on the market. The Danish Medicines Agency supervises medical devices marketed in Denmark.
CE marking of medical devices shows that the product meets the safety and performance requirements, etc. of the Executive Order.
The Danish Medicines Agency assesses software and apps on the basis of the EU Commission's guideline MEDDEV 2.1/6 2012 – Qualification and Classification of stand alone software and the Danish Executive Order of 15 December 2008 on Medical Devices. The Executive Order implements Council Directive 93/42/EEC concerning medical devices into Danish law, which means the assessment frame for apps and software is the same throughout the EU.
In order for an app to be considered as a medical device, it must have a medical purpose falling within the definition of a medical device, e.g. to diagnose or treat a disease.
The risk classification of apps follows the classification rules applicable to medical devices. The majority of apps that are CE marked as medical devices are Class I medical devices (lowest risk class).
Many health apps do not have a medical purpose that falls within the definition of a medical device. These health apps are therefore not medical devices and should not be CE marked.
Examples of apps that are medical devices
An example of an app to be CE marked as a medical device could be an app that is to support the use of a medicine and can adjust the dose based on entered information or measurements specific to the person taking the medicine.
An other example could be an app which serves as a diagnostic aid, e.g. by analysing an image of a mole to detect cancer.
It could also be an app which makes specific recommendations about treatment on the basis of data analysis or which analyses the results of a specific treatment and monitors treatment.
Examples of apps that are not medical devices
Apps designed to remind people to take their medication are not medical devices. Some apps have built-in reminder and notes functionality. They may also provide general information about how to take medicine correctly and general information about medicines. Since they have no specific medical purpose, they do not fall within the definition of a medical device. They are therefore not intended to be used specifically for diagnostic of therapeutic purposes.
Lifestyle, exercise and wellness apps
There is a variety of apps on the market that offer health-related functionality, e.g. apps for heart rate measurement, caloric intake, dietary advice whose purpose is not medical. The vast majority of health apps are considered to be fitness or wellness apps that consumers can use for a variety of purposes related to diet, exercise, lifestyle etc. These apps are not medical devices and should not be CE marked.
Be critical when using health apps
Consumers should be critical when they use health apps and should look for the CE mark in the user information for apps that have a medical purpose.
If you are concerned about your health, the Danish Medicines Agency advises you to contact your doctor rather than diagnose or treat yourself through the use of apps.