Patients nowadays have access to an enormous range of medical knowledge through social media, websites and health apps (in combination with wearables). The latter have become increasingly popular in recent years because of their ability to monitor in real time pulse, blood pressure, blood glucose levels and other parameters. Doctors are also intrigued by the promising opportunities of technological innovation. Digital health products that provide diagnostic and therapeutic options therefore have tremendous social and economic potential. According to market research, even though tremendous revenue is already being generated, the digital health industry is still in its infancy and innovative start-ups have many promising opportunities to grow, especially in Europe.
One of many examples is the mySugr app, developed by an Austrian start-up and recently sold to major industry player Roche Diabetes Care. The app helps medical teams adjust diabetes therapy and helps patients manage their everyday lives ("making diabetes suck less"). By law, the app is registered as a medical device, but can be quite difficult to determine when software should be considered a medical device. A controversial case was brought before the ECJ for a preliminary ruling last year, because the classification of the software was in dispute.
ECJ: Indications for qualification of software as a medical device
The software in question was a product by the Philips group called ICCA (IntelliSpace Critical Care and Anesthesia). ICCA is a clinical care solution that strives to simplify clinician workflow and enhance patient care, mainly in critical care environments. It integrates information from vital sign monitors or ancillary bedside devices. Its features include an adverse drug event notification system, a dynamic pre-anaesthesia evaluation form and intelligent drug order and infusion management. Put simply, the software accesses data, processes it and gives the attending physician recommendations.
In a judgment dated 7 December 2017, the ECJ followed the advocate-general's opinion and came to the conclusion that ICCA is indeed a medical product and therefore falls under Sec 1 Para 2 lit a MDD. In this context, the legal basis applicable to the ECJ case was the Medical Devices Directive (MDD; Directive 93/42/EEC). The MDD has by now been partly replaced by the Medical Device Regulation (MDR; Regulation 2017/745/EU), which will be fully applicable from 26 May 2020.
According to the legal definition of the MDD (and the MDR), software must always be regarded as a medical device if it satisfies two cumulative conditions: (i) the purpose of the product pursued, and (ii) the action resulting therefrom. Thus, according to the ECJ, the software needs to be used for one of the purposes listed in Sec 1 Para 2 lit a MDD (i.e. it needs to pursue a specifically medical objective) and must not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means.
In essence, the ECJ declared that Philip's ICCA meets both prerequisites. In respect to the necessary medical objective it proclaimed that ICCA "cross-references patient-specific data with the drugs the doctor is contemplating prescribing, and is thus able to provide the doctor, in an automated manner, with an analysis intended to detect, in particular, possible contraindications, drug interactions and excessive dosages." Regarding the second precondition, the ECJ found that the criterion "in or on the body" can be neglected. Even if the software has no direct influence on the body, it is not per se precluded from classification as a medical device. Rather, the ECJ considers indirect influencing of the state of health as sufficient; notably when the software influences the physician's treatment decisions.
Consequently, if software is considered a medical device, it must correspond with European legal requirements and therefore be marked CE before it is placed on the market. This indicates the product's compliance with EU regulations and confirms that it meets certain standards of performance, quality, safety and efficacy. Once the CE marking has been obtained, the product can be marketed in the EU and freely distributed there without the need for further certification.
Significance of the ECJ ruling
In consideration of the available non-binding guidelines published by the EC (MEDDEV 2.1/6) and the general market custom, the decision of the ECJ has been hardly surprising for industry experts. Nevertheless, it is of relevance. MEDDEV 2.1/6 is legally non-binding medical device guidance on the qualification and classification of standalone software used in healthcare. It was drafted by the European Commission and pursues the objective of ensuring uniform application of the relevant provisions of the Regulations within the EU.
While it may be expected that national authorities' handling of cases will be more consistent with the EU's legislation, the decision provides indications as to how a classification should be made correctly. The ECJ's emphasis on MEDDEV 2.1/6 being used to assess the classification of software was especially important. Due to the ECJ ruling, software developers can continue to use the MEDDEV 2.1/6 guide as a valuable resource.
Despite the new MDR, the European legislator will have a hard time keeping up with the rapid pace of the medical technology revolution. As a result, the assessment of whether to consider software as a medical device will remain a complex matter. In any case, according to the judgment, it is certain that decision support software is most likely to be considered a medical device. In order to avoid issues resulting from an incorrect classification, we advise conducting a case-by-case assessment.