When Clinical Software Becomes a Regulated Device

Whether your clinical software is a regulated medical device is decided by what you claim it does, not by how it is built. The same model can be an unregulated administrative tool with one intended-use statement and a class III device with another, and the statement is yours to write. Information, not legal advice, and not clinical or regulatory advice. Reviewed 4 August 2026. Device classification is fact-specific and the consequences of getting it wrong include enforcement action and product withdrawal. Use a regulatory professional. This page describes the questions that decide the answer; it does not answer them for your product. The line, in one paragraph per jurisdiction European Union. Software is a medical device if the manufacturer intends it for a medical purpose — diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease — as set out in the definition in Regulation (EU) 2017/745, the Medical Device Regulation, or the corresponding definition in the In Vitro Diagnostic Regulation (EU) 2017/746 where it works on specimens. There is no clinical decision support carve-out. Software that drives or influences the use of a device, or provides information used to take decisions for diagnostic or therapeutic purposes, is in. United States. Software is a device under the Federal Food, Drug, and Cosmetic Act if it is intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease — but section 520(o), added by the 21st Century Cures Act in 2016, excludes certain clinical decision support software from the device definition entirely, on four cumulative conditions. That carve-out has no EU equivalent and it is the single biggest structural difference between the two regimes. EU: qualification then classification Two questions in order. Qualification asks whether it is a device at all. Classification asks which class, which determines the conformity assessment route and whether a notified body is involved. Qua