Swiss MedTech and EU access

Before May 2021, Swiss MedTech enjoyed smooth access to the EU/EEA under mutual recognition. That changed when Switzerland, after the non-acceptance of the Institutional Framework Agreement, lost mutual recognition for medical devices and began to be treated as a “third country.” Since then, EU importer and distributor roles have had to be formalised. Importers generally do not need to take ownership, although in some cases certain authorities have asked non-EU manufacturers to transfer title to the EU importer based on non-binding guidance or local practice. The result has been uncertainty for financial flows and operating models that were previously straightforward.

EU product rules rest on a horizontal foundation—the Blue Guide—that frames “placing on the market” around the first making available. That includes transfers of ownership, possession or any other right and does not require the importer to acquire title. The MDR follows this approach. While importers have clear regulatory tasks, they are not forced into commercial roles. Some MDCG wording mentions “property right,” which is non-binding and has been read differently in practice. In our experience, Swiss manufacturers can keep standard sales models and compensate importers via service fees under Article 13 MDR.

The EU is preparing a horizontal update to the NLF, with early 2026 as the indicative timing. This kind of cross-cutting reform is the right place to settle definitions and roles across product laws, including MedTech, so companies can plan with confidence.

Switzerland and the EU have tabled the “Bilatérales III” package, under consultation since June 2025, which could restore a preferred market-access status and reduce current frictions for MedTech. The consultation outcome was positive, but political questions remain, especially around the automatic uptake of EU technical norms (“reprise automatique”). A final outcome is not assured and timelines may depend on parliamentary and potentially popular votes.

At PwC, we help your MedTech company to craft operating models that distinctly separate regulatory and commercial roles, ensuring compliance with MDR while maintaining stable financial flows. Our team combines expertise in regulatory (MDR/IVDR), legal, tax/customs, and supply chain to turn the Blue Guide and MDCG into actionable, auditable processes.

Here's how we can assist you: We help identify 'first making available' points and importer duties, review and update contracts and quality documents, and establish transaction notifications and evidence trails. We also prepare your teams for audits and market-surveillance discussions. Plus, we keep an eye on the NLF revision and Switzerland’s Bilatérales III, ensuring your model remains robust regardless of political shifts.