What is Not a Medical Device?
Overview
Not every health-related product is a medical device under Swiss law. Correct identification of scope avoids unnecessary regulatory burden and prevents misclassification. Exclusions fall into two categories: products explicitly outside MedDO scope, and products that simply don't meet the intended purpose test.
Explicitly Excluded Product Types
Medicinal products — Products achieving their principal action by pharmacological, immunological, or metabolic means are regulated as medicines under TPA Chapter 2, not as medical devices. If a device incorporates a medicinal substance as an integral part, special rules apply — see Devices Incorporating Medicinal Substances.
Cosmetics — Products intended solely for external application for aesthetic or cleansing purposes are regulated under the Cosmetics Ordinance (SR 817.023.31). A moisturiser without a medical claim is a cosmetic; the same product claiming to treat eczema may become a medical device.
Food and food supplements — Regulated under food law (SR 817.0) regardless of health benefit claims.
PPE for occupational safety — Protective equipment worn to protect the wearer from external hazards (not to protect a patient) is not a medical device unless it carries a medical claim.
General-purpose laboratory equipment — Centrifuges, pipettes, and general chemistry analysers used for scientific/industrial purposes without a specific IVD intended purpose are not medical devices.
Administrative healthcare software — Patient management systems, scheduling software, and EHR systems that do not use patient data to drive clinical decisions are generally not medical devices.
The Intended Purpose Test is Decisive
In every borderline case, the question is whether the manufacturer has declared or implied a medical intended purpose. Removing a claim can take a product outside MedDO scope — but only if the claim is consistently absent from all materials. See Borderline Products.
Official Sources
Related Pages
Content is AI-assisted and intended as a navigation aid only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.