Switzerland's Medical Devices Ordinance (MedDO, Medizinprodukteverordnung, MepV) closely mirrors MDR in substance. Since the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devices expired on 26 May 2021, Switzerland is treated as a third country. EU manufacturers placing devices on the Swiss market must appoint a Swiss Authorised Representative (CH-REP), meet Swiss labeling requirements, and comply with Swissmedic registration rules. The MedDO framework is close enough to MDR that CE-marked devices still ship to Switzerland, but the administrative overhead is real.

By Tibor Zechmeister and Felix Lenhard.

TL;DR

  • Switzerland applies the Medical Devices Ordinance (MedDO / MepV), which transposes MDR requirements into Swiss law and recognises CE marking for market access.
  • The EU-Switzerland MRA for medical devices expired on 26 May 2021, which means Switzerland became a third country for EU medical device manufacturers on that date.
  • EU-based manufacturers must appoint a Swiss Authorised Representative (CH-REP) whose name and address appear on the label or IFU.
  • Swissmedic is the Swiss competent authority and maintains national registration requirements, including a Single Registration Number and device registration obligations.
  • Swiss labeling requires information in the three official Swiss languages as relevant (German, French, Italian) and sometimes English.
  • MedDO articles that mirror MDR Articles 10, 11, 13 and 14 are the core operator obligation chapters; specific article numbering in MedDO differs from MDR.
  • For most EU startups, Switzerland is a low-complexity third market once the CH-REP relationship and label updates are in place.

Why this matters

Switzerland is a small country with an outsized MedTech footprint. Basel, Zurich, Geneva and Bern host dozens of medical device headquarters and many of Europe's most demanding hospital purchasers. EU MedTech startups rarely skip Switzerland intentionally. They skip it accidentally, because nobody on the team realised that "CE-marked and therefore legal in Switzerland" stopped being true on 26 May 2021.

The consequence of getting Switzerland wrong is rarely a product recall. It is more likely a silent loss of a tender because the label is non-compliant, or a distributor returning a shipment, or a hospital procurement department rejecting a submission. These problems are quiet and embarrassing. They are also entirely preventable with a few weeks of planning.

What MedDO actually says

The Medical Devices Ordinance (MedDO, in German Medizinprodukteverordnung or MepV, in French Ordonnance sur les dispositifs médicaux or ODim) is the Swiss Federal Council ordinance that governs medical devices placed on the Swiss market. It entered into force on 26 May 2021, replacing the previous Swiss medical device framework.

MedDO transposes the substance of Regulation (EU) 2017/745 (MDR) into Swiss law. General safety and performance requirements, classification rules, conformity assessment routes, clinical evaluation expectations and post-market surveillance obligations in MedDO follow MDR logic closely. Swiss law accepts conformity assessment by EU Notified Bodies and recognises CE marking as sufficient evidence of conformity for market access, provided the other Swiss-specific requirements are met.

The critical difference is political and administrative, not technical. Before 26 May 2021, the EU-Switzerland Mutual Recognition Agreement on Conformity Assessment (the MRA) covered medical devices in Chapter 4. Under the MRA, EU and Swiss manufacturers could treat each other's markets as domestic: no foreign authorised representative needed, mutual recognition of conformity assessments, direct market access. Negotiations for an updated MRA reflecting MDR collapsed, and the medical devices chapter of the MRA was not updated in time. From 26 May 2021, Switzerland became a third country for EU medical device purposes, and the EU became a third country for Swiss manufacturers.

For EU manufacturers, this triggers the third-country obligations set out in MedDO. The most visible is the requirement to appoint a Swiss Authorised Representative (CH-REP). MedDO requires a CH-REP for manufacturers not established in Switzerland. The CH-REP's name and address must appear on device labeling or accompanying documentation, and the CH-REP takes on Swiss-specific regulatory obligations analogous to the MDR authorised representative described in MDR Article 11.

Swissmedic is the federal agency responsible for medical device oversight in Switzerland. It maintains a Swiss registration system and assigns a single registration number to manufacturers, authorised representatives, and importers. Economic operators importing devices into Switzerland must register with Swissmedic, and certain devices trigger additional registration obligations.

A worked example

A Vienna-based startup CE-marks a Class IIa wearable cardiac monitor under MDR in early 2026. Their first major customer is a hospital network in Geneva with sites in Lausanne and Zurich. The founders assume their MDR CE mark is sufficient for Switzerland. Their MDR authorised representative is in Germany.

The procurement team in Geneva sends a supplier questionnaire. Two questions are unanswerable with the current state of the documentation: "Name and address of your Swiss Authorised Representative (CH-REP)?" and "Swissmedic single registration number?" The tender submission is rejected as incomplete.

The startup needs to do four things, none individually hard, all of which take real calendar time:

  1. Appoint a CH-REP under a written mandate that defines responsibilities, document access, and liability allocation. Most CH-REP services charge between 4,000 and 12,000 CHF per year depending on scope.
  2. Update device labeling and IFU to include the CH-REP name and address. This is a labeling change, which under the QMS (EN ISO 13485:2016+A11:2021) triggers a controlled change procedure, updated design outputs, and stock rotation planning.
  3. Register with Swissmedic through the CH-REP, obtaining the Swiss single registration number.
  4. Confirm that labeling languages meet Swiss expectations. For a cardiac monitor used by clinicians, German and French are typically sufficient; for lay-user devices Italian may be required. Document the language decision in the risk management and labeling files.

Elapsed time from decision to Swiss-ready: six to ten weeks for an organised team. Cost: 8,000 to 20,000 CHF in first-year fees and internal time. The next tender is submitted complete. This is the realistic Swiss entry path for an EU startup in 2026.

The Subtract to Ship playbook for Switzerland

Step one. Decide whether Switzerland is a target market in the next 12 months. If yes, add it to your regulatory roadmap. If no, do not spend money on CH-REP retainers "just in case."

Step two. Select a CH-REP before you need one. Good CH-REP providers are often MedTech consultancies or specialised legal firms based in Switzerland. Evaluate on document-handling processes, SRN registration experience, language capability, and fee transparency. The CH-REP sees your technical documentation, so treat selection like any other critical supplier qualification under your QMS.

Step three. Sign a written CH-REP mandate covering the scope of responsibilities, document access, incident reporting flow, termination and post-termination obligations, and liability allocation. The mandate should mirror the spirit of an MDR Article 11 authorised representative agreement, adapted to Swiss law.

Step four. Plan the labeling change. Treat it as a design change under your QMS: risk assessment, updated labeling files, stock rotation strategy, communication to distributors. Do not try to retrofit Swiss labels on existing stock without version control.

Step five. Register with Swissmedic via the CH-REP. Obtain the Swiss single registration number. Keep it alongside your other regulatory identifiers in a single operator registry spreadsheet.

Step six. Confirm Swiss language requirements for your device category. For lay-user devices, plan for German, French and Italian. For professional-use devices, German and French often suffice, but tender documents may still require Italian. English alone is almost never acceptable.

Step seven. Treat Switzerland as a third country in your post-market surveillance and vigilance processes. Serious incidents involving Swiss users must be reported to Swissmedic in parallel to EU competent authority reporting. Align your vigilance SOP to handle both jurisdictions.

Step eight. Revisit the CH-REP relationship annually. Fees, responsibilities and regulations drift. A once-a-year 30-minute sync prevents surprises.

Reality Check

  1. Have you confirmed whether Switzerland is in scope for the next 12 months of commercial activity?
  2. Do you have a written CH-REP mandate in place, or are you still relying on the assumption that your MDR authorised representative covers Switzerland?
  3. Does your device labeling currently carry the CH-REP name and address?
  4. Do you have a Swissmedic single registration number?
  5. Have you confirmed the language requirements for your specific device class and user profile?
  6. Does your vigilance SOP explicitly address Swiss reporting obligations in parallel to MDR reporting?
  7. Do you know the current CH-REP annual fee and what is and is not included?
  8. Have you aligned your document control processes so CH-REP access to technical documentation is managed and auditable?

Frequently Asked Questions

Is our MDR CE mark still recognised for Switzerland? Yes. MedDO recognises CE marking based on MDR conformity assessment as a core element of market access. What changed in 2021 is the surrounding administrative framework, not the recognition of CE marking itself.

Can our EU authorised representative also act as CH-REP? No. Since Switzerland is a third country for EU medical device purposes, the CH-REP must be a legal or natural person established in Switzerland. An EU-based authorised representative does not satisfy the Swiss requirement.

How much does a CH-REP cost? Annual fees typically range from 4,000 to 12,000 CHF for a single device family, depending on scope, incident handling volume, and whether the CH-REP also manages Swissmedic registration. Very small device portfolios can be lower; complex multi-device portfolios can be higher.

Does Switzerland require a separate clinical evaluation? No. Your MDR-compliant clinical evaluation report (CER) is the same document Swiss authorities expect. Swissmedic audits and inspections assess the CER on MDR terms because MedDO transposes those requirements.

What labeling languages are required in Switzerland? It depends on the device and user profile. German and French are near-universal; Italian is often required for lay-user devices; English is sometimes acceptable as an additional language but rarely as the sole language. Confirm the specific requirement for your device class as part of the labeling change.

Do Swiss vigilance reports go to Swissmedic or to an EU competent authority? Serious incidents involving devices used in Switzerland are reported to Swissmedic. For devices also used in EU member states, the EU competent authority reporting remains unchanged. A single incident can trigger both reporting flows.

Does MedDO affect our QMS? Only marginally. Your EN ISO 13485:2016+A11:2021-based QMS already supports the requirements MedDO transposes. The QMS additions are the CH-REP relationship management, Swiss labeling control, and Swiss vigilance reporting flow.

Sources

  1. Medizinprodukteverordnung (MepV) / Ordonnance sur les dispositifs médicaux (ODim), Swiss Federal Council, in force from 26 May 2021.
  2. Regulation (EU) 2017/745 on medical devices (MDR), Article 11 (authorised representatives) as the conceptual parallel to CH-REP.
  3. Swissmedic, official guidance on medical device market access and CH-REP obligations, current version.
  4. EU-Switzerland Mutual Recognition Agreement, Chapter 4 on medical devices (status: not updated for MDR, medical devices chapter effectively expired 26 May 2021).