Borderline & Combination Products
Overview
A borderline product is one whose regulatory status under Swiss law is unclear — sitting between MedDO and IVDO, between MedDO and medicinal product law, or between MedDO and cosmetics/food law. Classification is the manufacturer's responsibility, but Swissmedic can be consulted for an opinion.
MedDO vs IVDO Borderline
If a product both collects specimens for in vitro analysis and applies a therapeutic action, the principal intended purpose determines the applicable ordinance. Point-of-care devices with both diagnostic and therapeutic functionality require a principal-function determination.
Device vs Medicinal Product
A device incorporating a medicinal substance as an integral part remains a medical device — but is classified as Class III and requires an ancillary medicinal substance assessment. The medicinal action must be ancillary to the device's physical action. See Devices Incorporating Medicinal Substances.
Device vs Cosmetic
The intended purpose (and therefore the labelling claims) is decisive. A product claiming to treat a skin condition is a medical device or medicinal product; the same product claiming only to moisturise is a cosmetic.
How to Obtain a Swissmedic Borderline Opinion
Submit to Swissmedic: product description, intended purpose as stated in labelling, mechanism of action scientific basis, and existing regulatory classifications from other jurisdictions. Opinions are advisory but provide important regulatory certainty.
Official Sources
AI-assisted content for navigation only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.