Switzerland is one of the most lucrative medical device markets in Europe — with high purchasing power, world-class hospital infrastructure, and a strong MedTech industry. But it operates under its own regulatory framework, entirely separate from EU MDR. This guide covers everything you need to enter the Swiss market legally in 2026.
Many manufacturers assume that CE marking under EU MDR automatically covers Switzerland. It does not. Switzerland is not an EU member state. Following the collapse of the Swiss-EU Institutional Framework Agreement, Switzerland's mutual recognition agreement with the EU for medical devices was not updated to cover EU MDR or IVDR. Switzerland adopted its own Medical Devices Ordinance (MedDO / ODim) on 26 May 2021, creating a parallel — but independent — regulatory regime.
Your CE mark is accepted as the technical basis for Swiss market access, but you still need a separate CH-REP and separate Swiss registration. Think of it as a two-key system: CE mark is one key, CH-REP + Swissmedic registration is the other. You need both to unlock the Swiss market.
Step 1 — Obtain CE marking. Your device must hold a valid CE mark under EU MDR 2017/745 (or IVDR 2017/746 for IVDs). Switzerland accepts this as the technical conformity basis. If your device is Class I (self-declared), you still need the CE mark. For Class IIa, IIb, and III, a Notified Body certificate is required.
Step 2 — Appoint a Swiss Authorised Representative (CH-REP). The CH-REP must be established in Switzerland — a Swiss address is mandatory. The CH-REP registers your company in Swissmedic's database and acts as your legal point of contact for all Swiss regulatory matters. This is separate from your EU Authorized Representative.
Step 3 — Register with Swissmedic. Your CH-REP registers your company and each device in the Swissmedic database (Switzerland's equivalent of EUDAMED). Registration is required before any device is placed on the Swiss market or transferred in the Swiss supply chain.
Step 4 — Update your labelling. Device labels destined for Switzerland must include the CH-REP name and Swiss address. If you sell into both the EU and Switzerland, you typically need a Switzerland-specific label version or a combined EU/CH label.
Step 5 — Ensure IFU language compliance. Instructions for use (IFU) must be provided in German, French, and Italian — Switzerland's three official languages used in medical contexts. English alone is not accepted.
The CH-REP must be a natural person or legal entity established in Switzerland. They must be registered in the Swissmedic database before they can register your devices. The CH-REP takes on legal responsibility for your devices on the Swiss market, including vigilance reporting, field safety corrective actions, and Swissmedic communications.
NordMDR AB provides CH-REP services through a Swiss-based partner network. We handle the full Swiss market entry process — Swissmedic registration, labelling review, and ongoing compliance maintenance — as part of our CH-REP Switzerland service.
Costs depend on device class and the number of devices being registered:
NordMDR AB provides combined EU AR + CH-REP services — one engagement, two markets covered. Fixed annual fee, 5-day onboarding, Stockholm-based regulatory team.
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