How Intended Use Statements Determine If Clinical Software Is a Regulated Device

Whether clinical software qualifies as a regulated medical device depends on what its manufacturer claims it does, not how it is technically built. In the European Union, software is classified as a medical device under MDR (EU) 2017/745 if it is intended for a medical purpose such as diagnosis, treatment, or disease monitoring, with no exemption for clinical decision support tools. In the United States, the 21st Century Cures Act of 2016 added a carve-out under section 520(o) of the FD&C Act that can exclude certain clinical decision support software from the device definition, a provision that has no EU equivalent. Under EU rules, once software qualifies as a device, it is classified using Rule 11 of MDR Annex VIII, ranging from class IIa by default up to class III if its outputs could lead to death or irreversible health harm. Regulatory guidance MDCG 2019-11 remains the key reference document for European qualification and classification analysis, and promotional materials are treated as evidence of a product's intended purpose.