The fascinating possibilities of such applications evoke the infinite expanses of outer space and Star Trek style body scanners; according to a survey published on 06 August 2015 in the German medical journal Ärzteblatt, as much as 16% of the population believe health apps could replace the doctor’s visit.
The more factual earthly reality reveals that the number and distribution of apps is increasing rapidly, and often without compliance with relevant legal requirements. After all, a range of the popular medical apps fall under the medical device regime, and require certification.
On Google Play alone, a simple Internet search reveals 300 “top apps” in the medical category. Among them, for instance, the “DRACO wound app”, a practical doctor and nursing advi-sor to assist in the ambulatory care for chronic recurrent wounds. Here one can query information, have them evaluated, and receive advice on “optimal” and affordable wound care, which means that this app most likely constitutes a class I medical device. In any case, diabetes apps like Accu-Check Connect or mySugr Companion Pro require certification as medical devices if an interface to measuring devices is implemented. Furthermore, there is a vision test app for periodic review of visual acuity. This app, as well as a hearing test app, are probably medical devices that are subject to certification requirements.
There is also a “Jameda doctor search” app, which promises finding “the right doctor for you among 275,000 in Germany”. This app works much like a phone book with a geographical overview, with the option of making appointments; in terms of its purpose, it is not classified as a medical device. Another app, “Internal organs 3D (anatomy)”, which contains threedimensional models and descriptions of the organs of human body for rotation in three dimensions and zooming, and may be useful in studies of medicine or biology, is also certainly not a medical product. However, the distinction of medical devices for information purposes or wellness apps is not always easy.
The Federal Institute for Drugs and Medical Devices held a dialogue session titled “BfArM in Dialogue: Medical Apps” to this end, and has made available a “Guidance for Medical Apps” on its website as of the beginning of October 2015. The Federal Institute wishes to provide assistance in distinguishing between a pure wellness app and a medical device. Manufacturers are supplied with instructions for delimiting their apps by the intended use, labelling, user instructions and promotional materials on the basis of possible “clue terms” or “clue features”, as well as examples of delimitation and detailed representation regarding the risk classification of apps.
App developers should bear in mind that medical apps classified as medical devices are subject to CE marking requirements, and apps that are marketed as medical devices must comply with the same rules as all other medical devices, e.g. reporting requirements. Distribution of medical devices without CE marking, in violation of Sec. 6 para. 1 sentence 1 MPG [Medical Devices Act], is a criminal offence pursuant to Sec. 41 no. 2 MPG.
The delimitation of medical information or wellness applications from medical devices is not always easy. The identification of a stand-alone software such as a smartphone or tablet app as a medical device is based on the basic definition pursuant to Sec. 3 No. 1 MPG, which defines medical devices as “… software … or other items, including software employed by the manufacturer for diagnostic or therapeutic purposes, or for the proper functioning of medical devices, and which the manufacturer intends to be used for human purposes with features of
a) the diagnosis, prevention, monitoring, treatment or alleviation of diseases …”.
The delimitation from other product categories takes place on the basis of the subjective and objective intended purpose. The borderline is generally reached when what is provided is no longer purely information and the app intervenes by shaping data or information, the mere storage of data or communication in itself not resulting in classification as a medical device. For instance, a calorie counter app intended to support the user in getting that perfect bikini or swimsuit figure would be a pure wellness product, while a bread units counter app for diabetics with an integrated proposal calculator for insulin dosing is a medical device, and must thus be certified.
The classification of medical devices is regulated by Sec. 13 para. 1 MPG in conjunction with Appendix VIIII of Directive 93/42/EEC. According to rules 9-12, most medical apps likely belong to Risk Class I, or otherwise, for example when it comes to diagnosing or monitoring vital functions, of Class IIa or IIb.
Other decision-supporting tools are defined in MEDDEV 2.1/6 rev. 1 “Qualification and Classi-fication of stand-alone software”, a guideline for the delimitation and classification of standalone software by the European Commission, which has also prepared further advice, such as the “Commission Staff Working Document on the Existing EU Legal Framework Ap-plicable to Lifestyle and Wellbeing Apps”, SWD (2014) 135, final as of 10 April 2014, a com-panion document to another EU publication on this issue, “Green Paper on Mobile Health (“mHealth”)”, COM (2014) 219 final. Other health authorities have issued delimitation advice on their websites, such as the MHRA in the UK with the document “Guidance – Medical De-vice Stand-Alone Software Including Apps” of August 2014.
In any case, manufacturers of wellness or health apps should consider whether certification as a Class I medical device, which is currently the sole responsibility of the manufacturer, or as a Class IIa or IIb medical device with the required involvement of a Designated Body is required at the development stage, but at the very latest prior to market launch.
