Advances in information technology have resulted in increasingly “smart” medical devices that are capable of running software, lending these devices ever more complex functionalities. Often the relevant software comes as part and parcel of a physical medical device (e.g. a pacemaker or insulin pump). At other times, the software is developed and available independently of any particular devices; to be downloaded and used, for instance, as an app on a smart phone. There is no question that standalone software can be considered as a medical device in the eyes of the law, but the application of this law is far from clear or satisfactory in the age of digital medical devices.

In this paper, we set out some of the gaps and uncertainties regarding software as a medical device (SaMD). We make the case that the medical devices regulatory framework presupposes a model of medical device manufacture typical of hardware devices that software development – in particular open source software - models disrupt in a number of ways. For example, the collaborative, diffuse, global nature of some open source software leads to ambiguity in the application of key concepts in the medical device regulations. This includes determining at what point and whether software is “placed on the market”; identifying a legal “manufacturer”; and establishing whether certain forms of software – such as uncompiled code – fall within the definition of “medical device”.

We conclude that uncertainties in the application of the law stem from a bad regulatory “fit” between the framing of the Medical Device Regulations 2002 (and the EU Directives it implemented) around physical goods and the inherent intangibility of software. Given the increasing development and use of such software, this is something which needs to be addressed sooner rather than later.