Medical apps under the new European MDR

The proliferation of mobile devices and health care-related mobile applications is radically changing the way health care services are delivered. These health apps range from calorie counters and pedometers to blood glucose monitors and remote electrocardiogram (EKG) monitoring, which may also be connected to an electronic health record (EHR).

On average, 1 out of 3 smartphone users monitors their health or well-being with the help of an app[1] every day. With the addition of new features and characteristics, this trend is expected to increase with millions of new downloads of health-related apps, which are estimated to reach a total value of €31 billion in the upcoming years[2]. Even healthcare professionals have come to understand the immense potential of the use of medical apps, which led manufacturers of medical devices to heavily invest in this new and only partially exploited field.

Manufacturers should differentiate between medical and well-being apps, as only the former will be covered by relevant medical devices legislation. However, the distinction between a well-being app and a medical app is not always straightforward.

The labelled intended purpose remains the main criterion to determine the classification. For example, an app collecting and analyzing data on a persons’ diet for the purpose of maintaining their general well-being, such as weight loss, is qualified as a general well-being app and falls out of the medical devices legislation. However, the same app collecting and analyzing identical data for a medical purpose, such as the control and management of eating disorders or diabetes, would be considered a medical app.

Manufacturers should be aware that the legal requirements for medical apps (considered in most cases as a standalone software) will increase with the new Medical Device Regulation (MDR). The classification will no longer depend only on the labelled purpose of the device, but also on the risk assessment. This will have significant implications for medical apps, since many medical apps will fall in higher classification rule.

To learn more about the major changes introduced by the new Regulation on Medical Devices, or if you wish to learn more about the CE marking or the EU compliance process, contact us today!


[2] Estimated value for 2019.

in News