This collection examines what it takes to bring life-sciences products to the Swiss and EU markets. Articles cover medical device representation and trade arrangements, pharmaceutical promotion, pricing, distribution and merger review, as well as the flexibility Swiss law offers digital health without a statutory sandbox.
These articles provide general information and are not legal advice.
Switzerland has been a third country for medical devices since May 2021, and the Swiss-EU Bilaterals III protocols signed in March 2026 leave the devices chapter of the mutual recognition agreement to an undated Committee decision, so dual authorized representation persists.
Since the Swiss-EU mutual recognition agreement lapsed for medical devices in May 2021, Swiss makers need an EU authorized representative and EU makers a Swiss one, with registration in both device databases from mid-2026. Restoration under the Bilaterale III treaties may not come before 2028.
Since mutual recognition with the EU lapsed for devices, a Swiss manufacturer needs an EU authorized representative. If the manufacturer breaches its MDR or IVDR obligations, the representative is liable alongside it, so the mandate also allocates liability.
The Swiss therapeutic products act (HMG) and Directive 2001/83/EC bar public advertising of prescription medicines, and Swiss ordinances reach disease-awareness material, hospitality and samples. Several launch programs built for the FDA's Office of Prescription Drug Promotion (OPDP) are unlawful on arrival.
EU AI Act chatbot and content-label duties depend on role, output and exceptions. Pharma and MedTech communications are subject to medicines and device ad law.
Switzerland's three-year price review cut prices by about 11 percent on average across some 300 products a year in 2023–2025. For US companies with research there, the OECD minimum tax can partly reverse cantonal tax incentives such as the patent box.
A Swiss patent can block parallel imports of a price-regulated medicine even from the European Economic Area, but only while it and its supplementary protection last. Swiss antitrust law treats contract clauses barring such imports as hard-core restraints.
Switzerland has no statutory sandbox for digital health. Derogations, clinical investigations, and regulator dialogue give limited flexibility for market entry.
The revised Swiss competition act (KG) replaces the qualified-dominance test of Art. 10(2) KG with an EU-style significant impediment to effective competition (SIEC) test, so merger review will reach US MedTech and pharma deals well short of monopoly. Notification thresholds are unchanged.
Swiss device-integrity rules await commencement, while transparency, insurance and bribery duties already apply to selected arrangements. Free equipment, royalties and training need separate analysis under the proposed rules and the existing US framework.
FDA approval does not replace Swiss authorization. Reliance on the US review depends on product eligibility and the dossier; the Swiss holder, insurance listing and protection periods follow separate rules.
For advice on a particular matter, please get in touch.
Make an enquiry