Device

Whether a product is a device decides which rules apply. In the US the answer comes from the statutory definition, which excludes products that achieve their primary purpose through chemical action or metabolism.

collective term for MD and IVD

MDCG 2025-9, Section 1, Abbreviations and Terminology

an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is – recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term ‘device’ does not include software functions excluded pursuant to section 520(o)

FDA guidance: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions (August 2025), Footnote 1 (quoting section 201(h)(1) of the FD&C Act)

MDCG 2025-9 uses device only as a collective term for medical devices and IVDs. The FDA text quotes the FD&C Act definition, which lists the kinds of articles and intended uses that make a product a device.