International – Is your software a medical device?

Computer software used in healthcare device applications developed for demographic data gathering, physical examinations or therapies are increasingly part of the regulatory landscape. This article, based on presentations from RAPS Regulatory Convergence, October 2018, explores whether and when computer software, used in a variety of ways in healthcare is a medical device.1 The author reports on recent software and application regulations in both the European Union where medical device regulations were recently revised and the US, where the US Food and Drug Administration (FDA) is responsible for determining how and when software may or may not be considered a “medical device.”


Because many medical devices depend on computer software to carry out their tasks, the question of whether the software itself can be considered a “medical device” is important. A variety of questions have been raised about whether and when software can be considered a medical device and “what ifs” linked to this question are many and, accordingly, a number of regulatory experts offered their expertise and opinions in Vancouver.
For example, Melissa Walker, president and CTO of Graematter, Inc., posed many questions related to the central question of whether the computer software used in a medical device is, in itself, a medical device. She asked, “Can the software be used by itself, or only together with another medical device?” Is the software intended for users with specific medical conditions? What type of information is provided in the output of the device? How is the output information used, and by whom?

Walker also posed several “what if” questions to explore if software is in itself a medical device. In cardiac care, what if the data captured is used to assess the performance of the clinical team? What if the physician relies on the data to determine the next actions for a patient’s care? What if the “app” using the software collects data from a variety of digital devices or the output offers suggestions to the user for lifestyle changes or treatments?

The EU Perspective

In an effort to answer the questions, Sara Jafari, project manager for GMED North America looked at software as a medical device from the EU MDRperspective. According to Jafari, the new EU MDR regulations provide definitions, classifications, rules and procedural requirements for medical device software. This will have an impact on software currently regulated as Class I medical devices.2 MDR Article 2 says a “medical device” means any instrument, apparatus or appliance or software intended by the manufacturer to be used alone or in combination for humans for medical purposes, including diagnosis, prevention, monitoring, prediction, prognosis or treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability; investigation, replacement or modification of the anatomy or of a physiological or pathological process or state; providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.” MDR Article 2 further designates that software is considered as an “active device” by defining “active device” as any device the operation of which depends on a source of energy other than that generated by the human body or by gravity and which acts by changing the density of or concerting that energy…