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GUIDE ·

Entering Switzerland in 2026: authorised representatives, swissdamed and what changed

General information only, not legal or regulatory advice. Please read the legal notice at the end before relying on this guide.

In 2026, placing a medical device or IVD on the Swiss market takes a Swiss authorised representative, a Swiss importer, registration with Swissmedic and, from 1 July 2026, registration of every device in swissdamed. This guide explains each requirement, who carries it and what to do now.

What changed and when

Switzerland adopted EU-equivalent device rules, but the EU–Swiss mutual recognition agreement was not updated for them. Since then, Switzerland treats every manufacturer outside its borders, EU ones included, as a foreign manufacturer.

Date Change
26 May 2021 Medical devices: the mutual recognition agreement no longer covers new rules; the Medical Devices Ordinance (MedDO) applies
26 Nov 2021 Registration of Swiss economic operators (CHRN) in place
26 May 2022 IVDs: the In Vitro Diagnostic Medical Devices Ordinance (IvDO) applies on the same basis
Aug 2024 Economic operator registration moves into swissdamed
2 Mar 2026 EU and Switzerland sign an updated package of agreements, including the mutual recognition agreement; ratification pending
1 Jul 2026 Device registration in swissdamed becomes mandatory
31 Dec 2026 Transition period for devices already on the market ends
1 Jan 2027 CH-REP, importer and distributor must check swissdamed registration; first swissdamed fee invoices
1 Apr 2027 Importer details must be linked to each device registration

Sources: Swissmedic: swissdamed deadline, Swissmedic: obligations of economic operators, Swissmedic: swissdamed registration requirement, MedTech Europe.

Who needs a Swiss authorised representative

Every manufacturer of medical devices or IVDs without a registered office in Switzerland needs a Swiss authorised representative (CH-REP) before its first device is placed on the Swiss market. That includes manufacturers in the EU and EEA (Art. 51 MedDO, Art. 44 IvDO).

You are CH-REP needed?
A device or IVD manufacturer in the EU, UK, US or Asia Yes, one per generic device group at least
A device or IVD manufacturer with a registered office in Switzerland No, you are the Swiss manufacturer
An EU authorised representative for a non-EU manufacturer Your EU role does not cover Switzerland; the manufacturer still needs a CH-REP
A food supplement or cosmetics brand No CH-REP; other Swiss rules apply
A pharmaceutical company Not a CH-REP, but the marketing authorisation holder must have a Swiss address, office or branch (Art. 10 TPA)

The mandate must be in writing and must cover at least all devices in the same generic device group. A CH-REP is not a postbox: it carries real regulatory duties, set out in the next section.

What a CH-REP does, and how to choose one

The CH-REP is Swissmedic's point of contact for your devices and is responsible for the formal and safety-related matters of placing them on the market. Its main duties, from Swissmedic's information sheet:

  • Check that a declaration of conformity and technical documentation exist and that the conformity assessment was carried out.
  • Keep the technical documentation available, or ensure by contract that you deliver it to Swissmedic within 7 days of a request.
  • Have a Person Responsible for Regulatory Compliance (PRRC) permanently available.
  • Register with Swissmedic and hold a Swiss single registration number (CHRN).
  • Forward complaints to you, ensure serious incidents reach Swissmedic, and cooperate on corrective actions and recalls.
  • From 2027, check that your devices are registered in swissdamed.

Its address must appear on the label of MDR devices and IVD self-tests. For other IVDs it may sit in an accompanying document.

How to choose a CH-REP. Ask four questions:

  1. Does it have a qualified PRRC, and who is it? A name and qualifications, not a promise.
  2. Does it know your device class? An IVD self-test, a class IIb device and software raise different questions.
  3. How does it handle incidents and authority requests? Ask for its response process and timelines.
  4. Can it do more than represent you? If the same partner can also import and distribute, labelling, registrations and logistics stay in one place. That is where most coordination errors disappear.

The Swiss importer: the role you may already have

The importer is not appointed. Whoever in Switzerland places a device from abroad on the Swiss market becomes the importer automatically, with legal duties. A pharmacy or online shop that buys directly from you abroad is the importer; if it buys from a Swiss wholesaler, it is a distributor (Swissmedic, FAQ e).

CH-REP Importer Distributor
How the role arises Written mandate from the manufacturer Automatically, by bringing devices into Switzerland Automatically, by selling devices sourced in Switzerland
Registers with Swissmedic (CHRN) Yes Yes No
Name on device or packaging Yes, for MDR devices and IVD self-tests Yes, on device, packaging or accompanying document No
Checks conformity before selling Yes Yes Yes
Keeps a complaints register Forwards complaints Yes Yes
From 2027: checks swissdamed registration Yes Yes Yes

Why it matters to you as a manufacturer. If several retailers import your products directly, you have several importers, each with its own duties and its own name on your labelling. One Swiss importer for all channels keeps labelling, registration and traceability clean.

swissdamed: what to register, by when, and what it costs

swissdamed is Swissmedic's national database for medical devices and IVDs. From 1 July 2026 it replaces the old notification procedures, and every device sold in Switzerland must be registered in it (Swissmedic).

  • Who registers: manufacturers and their authorised representatives register devices, systems and procedure packs in the swissdamed UDI Devices module. Economic operators (CH-REP, importer) must already hold a CHRN before first placing a device on the market.
  • Which devices: all devices whose sales units are placed on the Swiss market after 1 July 2026, in all risk classes, including all IVDs.
  • By when: new devices before they are placed on the market. Devices already on the market have until 31 December 2026. Devices involved in a serious incident, field safety corrective action or trend report must be registered immediately, with no transition period.
  • Importer link: from 1 October 2026, importer details can be linked to device registrations; this must be done by 1 April 2027.
  • What it costs: CHF 200 for the first UDI-DI and CHF 20 for each additional UDI-DI marked "on the market", capped at CHF 10,000 per calendar year. First invoices go out from January 2027.
  • Still by form: repackaged or relabelled devices, in-house devices and custom-made devices stay with form-based notification.

What to do now. List every product and UDI-DI you sell or plan to sell in Switzerland, confirm who registers them (you or your CH-REP), and agree with your importer when the importer link will be made. From January 2027, Swiss partners will check registration before they sell, so an unregistered device is an unsellable one.

Labels and languages: a pre-print checklist

Check these before a single Swiss pack is printed:

  • Product information for lay users is in German, French and Italian, or uses standardised symbols in their place (Art. 16 MedDO, Art. 15 IvDO).
  • For IVD self-tests, the information is easy to understand and in all three languages.
  • The manufacturer's name and address are on the label.
  • The CH-REP's name and address are on the label (MDR devices and IVD self-tests) or in an accompanying document (other IVDs).
  • The Swiss importer's name is on the device, its packaging or an accompanying document.
  • Any Swiss repackaging or relabelling has been notified to Swissmedic before sale.
  • Marketing claims say nothing the product information does not (Art. 69 MedDO).

English-only information is allowed only for devices supplied exclusively to healthcare professionals, and only when the user agrees and safety is not put at risk.

Will the new EU–Swiss agreement change this?

Not yet, and not soon. On 2 March 2026 the EU and Switzerland signed a package that updates the mutual recognition agreement, so that products certified in one market can be accepted in the other without duplicate procedures. It takes effect only after the European Parliament consents, the Council approves and Switzerland completes ratification, which is expected to include a public vote. Until then, the current framework remains unchanged.

Two practical conclusions follow:

  1. Plan for today's rules. A launch in 2027 needs a CH-REP, an importer and swissdamed registration. Waiting for the agreement means waiting for an unknown date.
  2. Don't assume everything disappears later. Even with renewed mutual recognition, how the CH-REP role, Swiss labelling and swissdamed will be treated depends on the final texts. Good Swiss partners stay useful either way.

Frequently asked questions

We are EU-based and CE-marked. Can we simply ship to a Swiss retailer? No. You need a CH-REP first, and the retailer that receives your goods becomes the importer, with legal duties and its name on your labelling.

Can our Swiss distributor also be our CH-REP? Yes, if it is established in Switzerland, holds a CHRN, has a qualified PRRC and you give it a written mandate. Combining CH-REP, importer and distributor in one Swiss partner is common, and it keeps labelling and registrations consistent.

Our EU authorised representative already handles Europe. Does that cover Switzerland? Only if it has an establishment in Switzerland and is registered there as your CH-REP. An EU address alone does not qualify.

Do we have to translate our instructions? For lay users, yes: German, French and Italian, with standardised symbols allowed in place of text. English alone is possible only for professional-use devices under strict conditions.

Can we sell self-tests online in Switzerland? Self-tests may only be supplied where the dispensing point can guarantee professional advice, and tests for communicable diseases may not be sold to the public unless Swissmedic grants an exception (Art. 61 IvDO). Online sale is therefore possible, but how advice is provided has to be designed in from the start.

Our devices were on the Swiss market before July 2026. What now? Register them in swissdamed by 31 December 2026. If one is involved in a serious incident or field safety action, register it immediately.

How 11Alto helps

11Alto acts as Swiss authorised representative and importer for international health companies, registers devices in swissdamed, and can distribute and operate your brand in Switzerland under one contract. If you are planning a Swiss launch for 2027, now is the time to put the roles in place: write to info@11alto.com or use the contact form.

Legal notice

General information only. This guide is published by 11Alto AG for general information. It reflects 11Alto AG's reading of publicly available sources as of November 2026 and is not updated automatically. It is not legal, regulatory or other professional advice, and it does not replace an assessment of your specific product by a qualified adviser or the competent authority.

No advisory relationship. Reading or sharing this guide does not create a client, advisory or contractual relationship with 11Alto AG. Services such as authorised representation or importing are provided only under a separate written agreement, whose terms then apply.

No warranty, limited liability. 11Alto AG has prepared this guide with care but gives no warranty, express or implied, that it is complete, accurate or current. To the fullest extent permitted by law, 11Alto AG and its directors, employees and partners accept no liability for any direct or indirect loss arising from the use of, or reliance on, this guide.

Check before acting. Laws, regulations, fees, deadlines and authority practice change, and how they apply depends on each product and case. Confirm the current requirements with Swissmedic or another competent authority before taking any decision. Article references are given for orientation; only legal texts published in the official compilation of federal law (fedlex.admin.ch) are binding.

Third parties. Third-party names and trademarks remain the property of their owners. 11Alto AG is not responsible for the content of linked websites.

Applicable law. This notice is governed by Swiss law. The place of jurisdiction is Zürich, Switzerland.

Sources