April 6, 2017
Medical apps under the new European MDR
Worldwide 1 out of every 3 internet users currently monitors their health or fitness using an app. This was shown in a recent survey by market researcher GfK. Millions of health-related apps are downloaded every year, and this is expected to be in the billions in 2017. Most of these apps are consumer products being used to monitor health and fitness data for general wellness purposes.
Following consumers, healthcare professionals have started adopting the use of apps and more and more apps are being developed specifically for medical purposes. This is not unexpected; the potential of medical apps is significant. Compared to expensive medical equipment, the use of apps is relatively inexpensive and can aid in managing chronic diseases, provide early diagnoses and improve patient doctor communication, thereby reducing the number of expensive hospital visits. For clinical research, the use of medical apps has the potential to provide higher quality data through continued data gathering, higher patient retention by providing direct feedback and reduced costs by decreasing the amount of study visits.
The use of medical apps in clinical practice is slowly moving beyond pilot phase and is being integrated as standard of care treatment. A good example is a Dutch cardiology app, which transmits measurements such as blood pressure, weight, and heart rate and enables the cardiologist to remotely monitor the patient’s condition and intervene if required. This app is currently being reimbursed by most major Dutch health insurers.
With their high popularity and huge potential, an increasing amount of app developers are starting to develop medical apps. But developers should be aware: according to European regulations, an app is considered a medical device when it records and registers data for further medical purposes, such as diagnosis, monitoring or treatment of a medical condition. This includes medical apps being used to collect data for clinical trials. These medical apps should comply with regulatory requirements regarding medical devices as set out in the European Medical Device Directive (93/42/EEC) and require a CE mark before they can be sold in the European Union.
The line between consumer app and medical device can be thin. An app collecting and analyzing data on a person’s diet for general wellness purposes is not considered a medical device. However, the same app collecting and analyzing the same data, but with the intended purpose to aid in the management of diabetes would be considered a medical device. It is the purpose (label) of the device that will make the difference.
The regulatory requirements for medical apps will increase in the near future with the arrival of the new Medical Device Regulation (MDR). The English text of the MDR was published by the European Commission in February 2017 and has specific texts regarding the use of standalone software (most medical apps fall in this category), most notably a new classification rule (rule 11). The major impact of this rule is that standalone software will be classified based on purpose and risk assessment and not based on purpose alone. This could have significant implications for medical apps. For example, an app which collects and transmits blood pressure and heart rate data with the intended use of assisting in the management of heart disease could be categorized as a class I device based on the current regulations, but could be considered a class IIb when risk assessment is taken into account. Since most medical apps are under current regulations classified as class I, the addition of this new rule could skyrocket your classification from a class I device to a class IIb or even class III device. Obtaining CE mark for these higher-class devices adds a significant regulatory load for the developer, including the involvement of a Notified Body, stricter Quality Management System requirements and stricter requirements for your design documentation, potentially increasing the requirement for clinical trials.
The new MDR is expected to be effective end May 2017, after which developers should be compliant with the new regulations. If you don’t have a CE-mark for your new medical app yet, you better start reading the MDR now! Together with other requirements in the new MDR such as greater requirement for pre-market clinical evidence and greater emphasis on post-market follow up, it is certain that the new MDR will have a huge impact for developers of medical apps.