In Part 2 of our series of consecutive articles on the reformed regulatory framework under the EU Medical Device Regulation 2017/745 (“MDR”), which will soon govern medical devices software (“MDSW”) in the EU, we will shed further light on the expansion of the definition of “medical device” and the importance of the intended purpose of healthcare-related standalone software in determining the regulatory requirements of companies offering such software in the EU.
Introduction: The Relevance of the Intended Purpose
As is already the case under the current EU Medical Device Directive 93/42/EEC (as amended by Directive 2007/47/EC – “MDD”), the purpose for which the software is intended to be used is and remains the critical factor when determining the obligations regarding regulatory compliance with the European medical devices regime. The intended purpose establishes whether standalone software is considered a medical device in the first place.
In particular with regard to so-called health apps or other apps related to biological functions or wellbeing (e.g., related to fitness, diet, sleeping habits, or mental health), no bright line can be drawn between normal software and MDSW. For example, an app that allows the user to monitor his or her food habits for weight control purposes will qualify as normal software, while the same app might qualify as medical device if the monitoring is intended to be used for prevention of diseases such as metabolic disorders. A standalone software application that is claimed by its manufacturer to be a natural