Combination Products
Overview
A combination product incorporates both a medical device and a medicinal product, where both components form an integral part and are not independently reusable. The regulatory pathway is determined by the primary mode of action — whether the product primarily works as a device or as a medicine.
Primary Mode of Action Determination
- Primary action is physical/mechanical → regulated as a medical device under MedDO; any incorporated medicinal substance assessed ancillarily → Class III
- Primary action is pharmacological/immunological/metabolic → regulated as a medicinal product under TPA Chapter 2; device component assessed within the medicinal product framework
The manufacturer makes the primary mode of action determination and documents the rationale in the technical documentation. Swissmedic may challenge or clarify the determination during conformity assessment or registration; a formal borderline opinion can be requested for novel or uncertain cases.
Swissmedic Engagement
For novel or complex combination products, early engagement with Swissmedic is strongly recommended. Swissmedic can provide guidance on the applicable regulatory pathway and coordinate between its device and drug divisions. A formal borderline opinion can be requested.
Official Sources
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