Mirror Obligations: EU Authorized Representative for Swiss Medical Device Manufacturers
Switzerland is the only country whose manufacturers face an exact mirror of their own rules. When the medical devices chapter of the EU-Swiss Mutual Recognition Agreement was not updated for MDR, Switzerland became a third country for Union purposes on 26 May 2021 and the EU became a third country for Swiss purposes on the same day. Since then a Swiss manufacturer needs an authorised representative in a Member State and an EU manufacturer needs a CH-REP in Switzerland. Everything on this page follows from that single symmetry.
Two almost identical sentences, pointing in opposite directions
Nowhere else in the world do two regulators write the same rule at each other. MDR opens Article 11 with this: "Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative." (MDR Art. 11(1))
Swissmedic states the reflection of it, in its own guidance for economic operators: "If the manufacturer of a device is not established in Switzerland, its devices may only be placed on the market once an authorised representative established in Switzerland has been designated" (Swissmedic MU600_00_016_MB, citing Art. 51 para. 1 MedDO and Art. 44 para. 1 IvDO), adding "This also applies to manufacturers established in the EU/EEA."
A manufacturer in Solothurn needs a representative in the Union. A manufacturer in Stuttgart needs one in Switzerland. That symmetry is the whole subject of this page, and it did not exist before 2021.
The chapter of the MRA that was never updated
Switzerland and the EU have a Mutual Recognition Agreement in conformity assessment, and for two decades its medical devices chapter meant a Swiss certificate and a Union certificate were the same document in practice. That chapter was not brought into line with MDR. Swissmedic put the reason plainly at the time: "It has not yet been possible to complete the updating of this agreement because it has been linked by the EU to progress made with the Institutional Agreement (InstA)." (Swissmedic, New regulations applicable to medical devices as of 26 May 2021)
From 26 May 2021, when the revised Medical Devices Ordinance (MedDO, SR 812.213) came into force alongside MDR, the free movement built on that chapter stopped for devices. The in vitro diagnostics side followed on 26 May 2022 with the IvDO (SR 812.219), whose amended version entered into force on 1 January 2025. Swissmedic recorded the consequence for its own manufacturers directly: "Swiss manufacturers are already required to appoint an authorised representative in the EU for their products as of 26 May 2021." (Swissmedic)
What each side now has to hold
Two mandates, two registration numbers, two addresses on the artwork. The table reads across, and it is deliberately symmetrical, because the obligations are.
| A Swiss manufacturer placing devices on the Union market | An EU manufacturer placing devices on the Swiss market |
|---|---|
| Designates a sole authorised representative established in a Member State (MDR Art. 11(1)) | Designates an authorised representative established in Switzerland, the CH-REP (Art. 51 para. 1 MedDO, Art. 44 para. 1 IvDO) |
| Mandate valid only when accepted in writing, effective at least for a whole generic device group (MDR Art. 11(2)) | Mandate effective at least for all devices of the same generic device group (Art. 51 para. 3 MedDO, referring to MDR Art. 11(2)) |
| Registers as an actor in EUDAMED and obtains an SRN (MDR Art. 31) | CH-REP and importer register with Swissmedic and obtain a CHRN (Art. 55 MedDO, Art. 48 IvDO) |
| Authorised representative name and registered place of business on the label (MDR Annex I, 23.2(d)) | CH-REP indicated on the label for MDR devices; a P.O. box, e-mail address or telephone number will not do |
| Certificate from a notified body designated under MDR | Certificate from a designated body, with Swiss unilateral measures allowing EU-certified devices onto the market |
One curiosity worth knowing: because of the customs treaty between Switzerland and Liechtenstein, a manufacturer in Liechtenstein is not obliged to designate a CH-REP. Nobody else gets that exemption.
The database Swissmedic is not allowed into
The lapse cut Swiss authorities out of the Union information flow as well as the goods flow. Swissmedic noted that it would continue to be denied official access to EUDAMED. For a manufacturer that is not an abstraction: EUDAMED actor and device registration for the Union market is done by you and your authorised representative, and Switzerland runs its own database in parallel. From 1 July 2026 registration of devices, systems and procedure packs in the swissdamed UDI Devices module becomes mandatory, with a transitional period to 31 December 2026 for devices placed on the Swiss market after 1 July. Two registration systems, two sets of identifiers, one product family.
That duplication is the practical cost of the missing MRA chapter, and it is why we usually recommend that Swiss manufacturers treat their Union EUDAMED registration and their swissdamed entries as one dataset with two outputs rather than two projects.
Where Swiss portfolios meet MDR resistance
Swiss export medtech concentrates in exactly the categories MDR treats most severely: orthopaedic and dental implants, hearing and neurostimulation devices, injection and infusion systems, surgical instruments of very high precision, and IVD reagents and analysers. Implantable devices sit in class III or class IIb under the Annex VIII implant rules, which means an Annex IX quality management system assessment plus technical documentation assessment, unannounced audits, clinical evaluation under Annex XIV with a post-market clinical follow-up plan, and for the highest-risk devices the scrutiny procedure. Long-standing clinical history is helpful evidence, but it has to be presented as an MDR clinical evaluation, not as a reputation.
The other frequent surprise is language. A Swiss manufacturer used to preparing German, French and Italian for the home market often assumes that covers Europe. It does not: each Member State determines the language in which information supplied with the device must be provided, and a full Union launch means instructions for use across the twenty-four official languages, plus answering a competent authority in the official Union language it nominates — a duty that falls to your representative.
Questions Swiss manufacturers and CH-REPs put to us
Our CH-REP is excellent. Can they act for us in the EU too?
Only if they hold a registered place of business inside a Member State. Article 11(1) is a territorial test, not a competence test. A CH-REP established solely in Switzerland satisfies MedDO and nothing in MDR, exactly as an EU representative satisfies MDR and nothing in MedDO.
Will the MRA be restored, and should we wait?
The medical devices chapter has not been updated since MDR applied, and the obligation on Swiss manufacturers to appoint an authorised representative in the EU has been in force since 26 May 2021. Planning a Union launch around a possible future change to a bilateral agreement is not a regulatory strategy; the mandate takes days to put in place and can be maintained at low cost.
We are an EU manufacturer. Do we really need a CH-REP if we already hold a CE certificate?
Yes. Swissmedic states that the requirement to designate an authorised representative established in Switzerland also applies to manufacturers established in the EU or EEA. Your CE certificate is what lets the device onto the Swiss market under Switzerland’s unilateral measures; it does not remove the CH-REP designation, the CHRN registration or the label entry.
How does the liability work if something goes wrong?
On the Union side it is joint and several: "Without prejudice to paragraph 4 of this Article, where the manufacturer is not established in a Member State and has not complied with the obligations laid down in Article 10, the authorised representative shall be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer." (MDR Art. 11(5)) That is why we scope every Swiss mandate against the actual technical documentation before signing. See pricing or get in touch.