Software can be a medical device even if it has no physical component at all. What matters is not the technology, but the purpose for which the manufacturer has intended the software. The classification directly affects which requirements the product must meet before it can be placed on the market, so it is worth clarifying already at the concept stage.<\/p>\n
When is software a medical device under the MDR?<\/strong><\/p>\n The EU Medical Device Regulation (MDR 2017\/745) defines a medical device on the basis of its intended purpose. Software is a medical device if the manufacturer has intended it to be used on humans for, for example, the diagnosis, prevention, monitoring, prediction, treatment or alleviation of disease. Software can be a device either as a standalone product or as part of another device.<\/p>\n Merely storing, archiving, transferring or performing a simple search of data does not usually make software a medical device. The Medical Device Coordination Group\u2019s guidance MDCG 2019-11 on the qualification and classification of software helps in drawing the line.<\/p>\n Why does intended purpose matter so much?<\/strong><\/p>\n The manufacturer defines the intended purpose, and it is derived, among other things, from the device\u2019s clinical benefits and from the patient and user groups. The same software can be a medical device in one context of use and not in another.<\/p>\n For example, a step counter that encourages people to be active is typically a wellness product. If the same software claims to detect arrhythmias or guides treatment decisions, it is in principle a medical device. This is why claims should be considered carefully already when designing the product, not only when writing the marketing copy.<\/p>\n How is the risk class of software determined?<\/strong><\/p>\n If the software is a medical device, its risk class is determined under the classification rules in Annex VIII of the MDR. The key rule for software is Rule 11. In broad terms:<\/p>\n In practice, many software products end up in class IIa or higher, which means a notified body is involved in the conformity assessment. Rule 11 is open to interpretation, so the classification should be carefully justified and documented.<\/p>\n\n