Do you need a Swiss authorised representative before placing medical devices in Switzerland? If you are a manufacturer established outside Switzerland, you may need to appoint a CH-REP depending on your role and how the product reaches the Swiss market. What is certain: once the obligation applies, the representative’s contactable name and address must sit next to the CH-REP symbol on the label, and registration runs through the Swiss database, swissdamed.
Why CH-REP readiness belongs at the start of a Swiss launch
A Swiss authorised representative (CH-REP) is the economic operator that represents a foreign manufacturer inside Switzerland. The Medical Devices Ordinance (MedDO, SR 812.213) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO, SR 812.219) set out the requirements and responsibilities for operators across the medical devices supply chain, and the CH-REP is one of the roles defined inside that framework. Revised provisions in both ordinances entered into force on 1 November 2023; according to Swissmedic materials presented through the IMDRF, these changes align Swiss provisions with EU requirements and restore equivalence with the EU MDR and IVDR.
The practical consequences surface early, not at the finish line. A reachable Swiss contact is needed for post-market questions, and the representative’s address has to appear on the label in a specific way. When the appointment is settled late, artwork gets reworked and downstream steps stall. Teams that treat CH-REP readiness as a pre-market workstream — rather than a box ticked at the end — tend to keep the launch calendar intact.
One caveat before the detail: this is an editorial overview, not legal advice. Provisions evolve, transitional situations apply case by case, and any plan should be reconciled against current Swissmedic guidance and the applicable ordinances. Swissmedic publishes an information sheet on the obligations of economic operators (reference MU600_00_016e_MB) that is worth keeping on hand as the authoritative source for the CH-REP, importer and distributor roles.
When a Swiss authorised representative comes into play
The starting point is the manufacturer’s place of establishment. A manufacturer without a Swiss registered office that wants to place a device or IVD on the Swiss market has to consider the CH-REP question, because Switzerland has its own identification and registration steps that do not resolve themselves through an EU appointment. The revised MedDO and IvDO have brought the Swiss framework closer to EU requirements, but the Swiss-specific steps remain separate obligations.
Edge cases deserve a careful read of your corporate structure. A group with a genuine Swiss legal entity may be able to carry the role internally, provided that entity can take on the associated obligations and evidence its Swiss domicile. Private-label and OEM arrangements raise a practical question: who is the legal manufacturer named on the label, and does that entity sit outside Switzerland? Contract manufacturing rarely changes the answer, because the legal manufacturer — not the production site — usually drives the obligation.
Legacy devices under transitional provisions are a live topic worth flagging. In September 2024, Swissmedic drew the attention of all registered Swiss authorised representatives and importers to the transitional provisions for legacy devices and asked them to verify their products with regard to this matter. If a portfolio includes legacy CE-marked devices, that verification belongs on the checklist rather than in an assumption.
CH-REP, EU authorised representative and importer are not the same role
An EU authorised representative appointed under the MDR or IVDR covers the European Union. It does not automatically cover Switzerland. The CH-REP is a distinct mandate with Swiss-specific steps: identification on the label, and registration with Swissmedic through swissdamed. There is a concrete, verifiable reason the two cannot simply merge — a Swiss Single Registration Number application requires evidence of domicile in Switzerland, such as an extract from the commercial register or a certificate of residence, which an EU-only operator cannot supply.
The importer is a third, separate actor. A Swiss importer brings devices into the country and carries its own obligations under the ordinances. Deciding early who holds which document, who communicates with the authority, and who coordinates on post-market matters tends to prevent the finger-pointing that stalls distributor onboarding later. It is better to agree these boundaries in writing before the first shipment than to negotiate them during an incident.
What to prepare before you appoint a CH-REP
A mandate works only if the manufacturer hands over a coherent package. At minimum, prepare device identification, intended purpose, the classification rationale, the declaration of conformity and relevant certificates, plus named contacts for post-market surveillance and vigilance. A representative cannot stand behind a dossier it has never seen.
Beyond paperwork, agree how complaints are received, how a field safety corrective action would be triggered, and who escalates an incident on each side — practical arrangements that are easier to define now than under pressure. Then map the supply chain: name the Swiss importer, identify the distributors, and decide how information flows between them and the representative. If you need a Swiss-based partner to hold the mandate, confirm the provider can support CH-REP scope for medical devices and IVDs; a Swiss Authorized Representative for medical devices should be able to document how it handles mandate notifications in swissdamed and how it answers authority queries.
Data consistency pays off once information enters a regulated system. Consistent device names and version control for instructions for use and labels reduce rework later, and registration of devices, systems and procedure packs in swissdamed becomes mandatory with effect from 1 July 2026, with a transition period until 31 December 2026. Clean records prepared ahead of that window are cheaper than corrections made against a deadline.
Choosing a representative: look past the Swiss postal address
A postal address in Switzerland is the minimum, not the qualification. Competence comes first: familiarity with MDR and IVDR logic combined with Swiss regulatory practice, and language coverage across German, French and Italian for labeling and correspondence. Responsiveness comes next — a representative that answers slowly becomes your bottleneck when the authority asks a question.
Then look at independence and confidentiality where a provider manages several clients, and at systems: quality management alignment, record retention and secure document exchange. A representative should be able to show, not merely assert, that records are retrievable and consistent. Finally, understand the commercial terms — the base fee, the cost of change control, and exactly what support is included — so the role is operational rather than a name on a label.
The mandate: clauses that prevent delays and disputes
Write the mandate so it holds through the whole product life cycle, not only the launch. Define scope precisely — which products, brands and legal manufacturers are covered — so a new SKU does not fall into a gap. Set out responsibilities and interfaces, including where documents are stored and how quickly they can be produced.
- Change management: how new SKUs, label changes, certificate renewals and regulatory updates are handled and priced.
- Continuity and termination: handover obligations, return of documentation, and how to avoid an interruption to market presence if you switch representative.
- Interfaces: who communicates with the authority and how post-market information reaches the representative.
Continuity is easy to skip and painful to miss. Because CHRN registrations and mandate notifications are submitted in the Actors module of swissdamed, agree in advance how the authority contact and the associated entries transfer if the mandate ends. Settling the mechanics before you need them avoids a scramble later.
Labeling: the details manufacturers most often miss
On Swiss labeling, the name and address of the authorised representative must appear adjacent to the CH-REP symbol, and that address must genuinely enable contact — Swissmedic states that stating only a P.O. box number, an email address or a telephone number is not sufficient. The relative size of the symbol and of the name are not defined, but both must be clearly legible to the naked eye.
The symbol carries the description indicating the authorised representative in Switzerland, and official downloadable symbol files have been available since June 2021. Where a harmonised standard exists, symbols should as a rule conform to it; where none exists for the area concerned, Swissmedic accepts the sole use of the symbol without a description in the enclosed product documentation. As an alternative to the symbol, it is permissible to write CH authorised representative, CH-REP, or Authorised representative for Switzerland.
Plan these details into the artwork cycle, not after it. Designing a legible Swiss address next to the symbol from the first artwork round is far cheaper than retrofitting one into approved packaging — which is exactly the kind of rework that delays shipments.
Registration and the CHRN, a step that is easy to underestimate
Economic operators must register with Swissmedic before placing a device on the Swiss market, pursuant to Art. 55 MedDO and Art. 48 IvDO. A Swiss Single Registration Number (CHRN) is assigned on request to allow unambiguous identification, and is issued to Swiss manufacturers, authorised representatives, importers, and manufacturers of systems and procedure packs. The number takes the form of the abbreviation CHRN, a role abbreviation and an eight-digit number — for example, CHRN-MF-23456789.
Applications for a CHRN, changes to it, and notifications of mandates are all submitted in the Actors module of swissdamed, and evidence of domicile in Switzerland must be attached. Because that evidence is Swiss-specific, it is the concrete reason an EU authorised representative cannot substitute for a CH-REP.
A realistic pre-market sequence
Order the work so nothing blocks a downstream step. Select the CH-REP early, finalise the mandate, then lock labeling and instructions for use, then onboard distributors. A worked example: because the representative’s contactable address must sit next to the CH-REP symbol on the label, the appointment has to be settled before artwork is signed off.
Set go/no-go checkpoints — mandate signed, labeling updated and legible, contacts tested with a real query. Keep the swissdamed picture on the same timeline: the CHRN process runs through the Actors module, and mandatory device registration carries the 1 July to 31 December 2026 window, so build in time rather than assuming it happens at the last minute. For an urgent launch, prioritise by risk and use documented, temporary mitigations — never shortcuts that leave a gap on the label or in the registration.
After launch: keeping the roles working
Once you are on the market, the questions become operational. Who answers an authority query, how fast, and with what evidence? How do the manufacturer, CH-REP and importer coordinate if a field safety corrective action is needed? These are best agreed as working arrangements, not left implicit. Ongoing maintenance — certificate renewals, documentation updates and the swissdamed entries — is continuous. Keeping the Swissmedic obligations information sheet close by helps each operator stay aligned on who is responsible for what.
Failure modes worth designing out
- Late appointment forcing label rework and delaying shipments.
- Unclear importer role stalling distributor onboarding.
- Weak version control leaving inconsistent IFU and label versions in the field.
- No tested escalation path for incidents, slowing the response to the authority.
- Contract gaps triggering disputes during product changes or termination.
Each of these is preventable with the same discipline: decide the roles early, put them in writing, and test them before the first shipment. Confirm whether a CH-REP is required for your corporate setup and product scope, map the operators from manufacturer to CH-REP to importer to distributor, prepare the document package with a defined update cadence, and design the CH-REP identification into your artwork from the first round rather than under deadline pressure.
