Non-Swiss manufacturers need a CH-REP before placing medical devices on the Swiss market. NordMDR appoints your Swiss Authorised Representative under MedDO — fast onboarding, Swissmedic registration, and swissdamed actor support.
Also searched as Swiss authorized representative, swiss authorised representative, or CH rep — same mandatory MedDO role.
🌐 Global Access: Serving US, UK, and APAC MedTech manufacturers entering Switzerland.
Our Stockholm-based team provides rapid, cross-border CH-REP mandates compliant with Swiss MedDO — not Nordic-only coverage.
Since Switzerland's Medical Devices Ordinance (MedDO) came into force, non-Swiss manufacturers must appoint a Swiss Authorised Representative (CH-REP) before placing any medical device on the Swiss market. Switzerland is no longer covered by your EU CE marking alone.
🚨 Critical Warning for Non-EU/Non-Swiss Manufacturers: Under post-May 2026 operational frameworks, Swissmedic is strictly auditing active distribution documentation. If your technical files do not name a formally appointed Swiss Authorised Representative (CH-REP), customs officials hold immediate authority to freeze import shipments at border entry points.
Speak with a Stockholm-based MDR consultant (2-hour response)
⚠️ Customs Notice: Missing your EUDAMED registration profiles? Switzerland enforces distinct cross-border parameters. If your device paperwork lacks a designated, active Swiss CH-REP, physical shipments face immediate holding actions at Swiss border customs.
Speak with a Stockholm-based MDR consultant (2-hour response)
New to the Swiss market? Read our full guide: How to Sell Medical Devices in Switzerland (2026) — step-by-step process, costs, and timeline.
From 1 July 2026, swissdamed registration is mandatory for all medical devices placed on the Swiss market. As a foreign manufacturer, you cannot register directly — your Swiss Authorized Representative (CH-REP) must register on your behalf. NordMDR acts as your CH-REP and handles your complete swissdamed registration, including actor registration (CHRN number) and device registration in the UDI module. Device registration deadline is 31 December 2026.
NordMDR AB provides full Swiss Authorised Representative (CH-REP) services — the term UK, Commonwealth, and EU manufacturers often search as Swiss authorised representative or swiss authorised representative (ch-rep). US and Canadian teams frequently use Swiss authorized representative (with a “z”). Both spellings describe the same mandatory Swiss MedDO role.
We support US, UK, EU, and APAC medical device manufacturers selling in Switzerland: Swissmedic registration, MedDO compliance, labelling review, and ongoing vigilance — with a Swiss-address CH-REP and fixed annual fee. Combine with our EU Authorized Representative service for one regulatory partner across Europe and Switzerland.
If you manufacture medical devices outside Switzerland — in the United States, United Kingdom, European Union, or Asia-Pacific — you cannot rely on your EU MDR compliance package alone. Swiss MedDO requires a separate, Switzerland-based CH-REP before any device is placed on the Swiss market. This is the core search intent for manufacturers comparing Swiss market entry options in 2026.
Step-by-step — appointing a Swiss CH-REP under MedDO:
| Requirement | EU MDR Authorized Representative | Swiss CH-REP (MedDO) |
|---|---|---|
| Legal basis | EU MDR 2017/745 Article 11 | Swiss MedDO (ODim) — independent Swiss law |
| Geographic address | Any EU member state (27 countries) | Switzerland only — Swiss address mandatory |
| Market covered | European Union (27 member states) | Switzerland only |
| Database registration | EUDAMED — actor SRN + device registration | Swissmedic database — separate from EUDAMED |
| Can one role cover both? | No — EU AR does not cover Switzerland | No — CH-REP does not cover the EU |
| Labelling | EU AR name and EU address on label | CH-REP name and Swiss address on label |
| Vigilance authority | EU Competent Authorities via EU AR | Swissmedic via CH-REP |
| Who needs it? | Non-EU manufacturers selling in the EU | Non-Swiss manufacturers selling in Switzerland (including EU, US, UK, APAC) |
| Typical search terms | EU authorized representative, EU Rep, EU AR | Swiss authorized representative, CH-REP, swiss authorised representative |
NordMDR AB can provide both your EU AR and Swiss CH-REP under one engagement — one regulatory partner for EU + Switzerland distribution. EU Authorized Representative services · Request dual-market quote
Switzerland is not a member of the European Union. Following the breakdown of negotiations over the Swiss-EU Institutional Framework Agreement, Switzerland's mutual recognition agreement with the EU for medical devices was not updated to cover EU MDR and IVDR. As a result, Swiss law now requires its own authorised representative (British spelling) or authorized representative (US spelling) — entirely separate from your EU AR.
The Swiss Medical Devices Ordinance (MedDO / ODim) came into force on 26 May 2021, aligning closely with EU MDR 2017/745 and IVDR 2017/746 in structure and requirements. However, it operates as independent Swiss law requiring independent Swiss registration and a CH-REP with a Swiss address.
Any manufacturer established outside Switzerland who places a medical device or IVD on the Swiss market must appoint a Swiss authorised representative (CH-REP). UK and Commonwealth manufacturers typically search “authorised”; US manufacturers often search “authorized” — both require the same Swiss-based CH-REP under MedDO. This applies to EU manufacturers and all other non-Swiss countries including USA, UK, China, Japan, and Australia.
The CH-REP must be established in Switzerland and registered with Swissmedic. Unlike the EU where your EU AR can be based anywhere in the 27 member states, the CH-REP must have a Swiss address.
Swissmedic registration. The CH-REP registers your company and devices in the Swissmedic database — the Swiss equivalent of EUDAMED — before any device is placed on the Swiss market.
Legal representation. The CH-REP acts as your legal representative to Swissmedic and Swiss Cantonal Authorities for all regulatory correspondence, vigilance reporting and market surveillance matters.
Labelling compliance. Switzerland has specific labelling requirements including the CH-REP name and address on device labels, and language requirements for Swiss official languages (German, French and Italian depending on the canton).
Vigilance reporting. The CH-REP coordinates vigilance reporting to Swissmedic for serious incidents and field safety corrective actions involving your devices on the Swiss market.
Switzerland continues to accept CE marking under EU MDR and IVDR as the basis for Swiss market access. Your devices must carry a valid CE mark before the CH-REP can register them with Swissmedic. The CH-REP arrangement works alongside your existing EU MDR CE marking — the two systems complement each other.
This means you need two representatives for Europe: your EU AR covering the 27 EU member states, and your CH-REP covering Switzerland. NordMDR AB can provide both services under a single engagement, simplifying your compliance structure significantly.
While MedDO closely mirrors EU MDR in structure, there are Switzerland-specific requirements including the mandatory CH-REP with Swiss address, Swissmedic database registration separate from EUDAMED, Swiss-specific labelling with CH-REP details, vigilance reporting directly to Swissmedic, and Swiss official language requirements for labelling and IFU.
Since the Swiss-EU mutual recognition agreement was not updated for EU MDR/IVDR, Switzerland operates MedDO as independent Swiss law — not as an extension of your EU compliance package. Post-May 2026, three gaps cause the most border and market-access failures for non-EU manufacturers:
Swiss labelling post-MDR: Labels must show CH-REP name and Swiss address, align with MedDO UDI expectations where applicable, and meet language rules for the target canton (German, French, or Italian). IFU translations are commonly required for professional-use devices sold nationally.
Vigilance: Serious incidents and FSCAs on the Swiss market are reported through your CH-REP to Swissmedic — parallel to, but separate from, EU vigilance via your EU AR.
A CH-REP is a legal entity based in Switzerland that represents non-Swiss medical device manufacturers to Swissmedic under Swiss MedDO. Appointment is mandatory before placing devices on the Swiss market.
Swiss authorised representative (British/Commonwealth spelling) and Swiss authorized representative (US spelling) are the same role: a Switzerland-based legal representative for non-Swiss manufacturers under MedDO.
Yes. Any manufacturer outside Switzerland — including US, UK, EU, and APAC companies — must appoint a CH-REP with a Swiss address and register with Swissmedic before selling in Switzerland.
CE marking under EU MDR/IVDR is required as the conformity basis, but it is not sufficient alone. You must also appoint a CH-REP and complete Swissmedic registration separately from EUDAMED.
No. Your EU AR covers the 27 EU member states only. Switzerland requires a separate Swiss authorised representative with a Swiss address registered with Swissmedic under MedDO.
No. EUDAMED registration is EU-only. Swiss market access requires CH-REP-led Swissmedic registration in addition to any EU EUDAMED actor and device profiles.
Labels must include CH-REP name and Swiss address, meet MedDO UDI rules where applicable, and comply with Swiss official language requirements for the cantons where you distribute.
Swissmedic verifies that technical files reference an active CH-REP, Swissmedic registration is current, and vigilance contacts are operational. Missing CH-REP details can trigger immediate customs holds at Swiss border entry.
They are the same role — the mandatory Swiss Authorised Representative (also searched as swiss authorized representative or ch rep) for non-Swiss manufacturers under MedDO.
NordMDR AB provides CH-REP services for non-Swiss manufacturers. We handle Swissmedic registration, labelling compliance and ongoing Swiss regulatory obligations — combined with EU AR services if required. Fixed annual fee.
Speak with a Stockholm-based MDR consultant (2-hour response)A CH-REP acts as the legal point of contact between a foreign manufacturer and Swissmedic. Duties include: registering the manufacturer and devices in swissdamed, receiving and forwarding vigilance notifications, maintaining technical documentation, and ensuring the device meets Swiss MedDO requirements.
Any manufacturer established outside Switzerland who wishes to place medical devices on the Swiss market must appoint a CH-REP under the Swiss Medical Devices Ordinance (MedDO). This applies to all device classes including Class I.
Yes. From 1 July 2026, swissdamed registration is mandatory for all medical devices placed on the Swiss market. Only the CH-REP can register devices on behalf of a foreign manufacturer.
No. They are separate legal roles under different regulations. Your EU AR covers all 27 EU member states under EU MDR. Your CH-REP covers Switzerland only under Swiss MedDO. Most non-European manufacturers need both.