Switzerland Medical Device Compliance Swissmedic Representative

Who needs a Swiss representative? Apply the establishment test

For medical devices MedDO Articles 51–52 apply; for IVDs IvDO Articles 44–45 apply. Classify the product as an MDR medical device, IVDR IVD, qualifying legacy device, or other regulated product before applying exceptions. Do not assume all software or combination products follow the same route.

The trigger is the first making available of each individual device on the Swiss market, not the first registration of a model. An agreement to transfer a finished device may amount to making it available even before physical handover. Confirm the CH-REP appointment before that first market placement; do not defer it until customs clearance, swissdamed upload or clinical use.

Separate the CH-REP, manufacturer and importer roles

PRRC exception: Swissmedic states that manufacturers and authorised representatives of eligible AIMDD/MDD/IVDD legacy devices are not required to have a PRRC. This exception must not be extended to MDR/IVDR devices in a mixed portfolio; check the legal route of every mandated device group.

What to verify before signing a CH-REP mandate

Treat a low-cost “address-only” offer as a red flag. The written appointment should be tested against these control points:

• Identify the legal manufacturer, Swiss-domiciled representative, effective dates, and every covered generic device group; EU MDR/IVDR Article 11 requires at least group-level scope.
• Confirm that the CH-REP has its role-specific CHRN, the needed PRRC capacity and a working Swissmedic communications channel. A CHRN identifies an actor; it is not device approval.
• Define access to declarations, applicable certificates and technical documentation. Swiss law permits an agreement for direct manufacturer submission to Swissmedic on request, but the CH-REP must ensure submission within seven days.
• Allocate complaints, serious-incident and field-safety-corrective-action escalation, cooperation, record retention and named contacts. A private mandate cannot waive statutory duties.
• Provide for renewal, termination, transfer, packaging updates and swissdamed mandate/device-record continuity when changing representative.

Where must the CH-REP appear on the product information?

Swissmedic’s May 2026 economic-operator information sheet makes label placement depend on the regulatory regime, not just risk class. Check the exact legal basis and whether the product is legitimately a legacy device:

These legacy alternatives apply only while the particular device lawfully qualifies for the old-law transition. “EU/EEA manufacturer or EC-REP” is a condition for choosing the placement row; it does not eliminate any otherwise applicable Swiss CH-REP appointment.

Where a CH-REP symbol is used, place the representative’s name and a contactable registered-business address next to it; a PO box, email or phone alone is insufficient. Swissmedic also accepts the written designations “CH-REP” and equivalent wording. Manufacturer and importer identification are separate checks; a document accompanying the device must actually travel with the relevant supply.

The manufacturer must still be identified on the label. Where this table permits an accompanying document for CH-REP details, that document must accompany the relevant device when it is placed on the market and through the supply chain; Swissmedic says it does not necessarily need to reach the end user. This is Swissmedic’s interpretation, not permission to omit manufacturer labelling.

2026 swissdamed: representation is not device registration

As of 1 July 2026, manufacturers and authorised representatives must register devices, systems and procedure packs in the swissdamed UDI Devices module. For relevant sales units first placed on the Swiss market from that date, the ordinary transition permits completion by 31 December 2026; registration linked to reportable serious incidents, field safety corrective actions or trends has no such grace period. Specific form-based notifications remain for defined categories such as custom-made and in-house devices.

• Before market entry: verify that the Swiss actor (CH-REP and any importer) is registered in the Actors module and has its role-specific CHRN; notify the mandate through that module.
• For a foreign manufacturer, verify that the appointed CH-REP has arranged registration of the mandated devices; Swissmedic identifies the CH-REP as the registering Swiss actor. EUDAMED data does not synchronise automatically with swissdamed. This task is distinct from actor CHRN and the written mandate.
• Importers: the swissdamed importer-link function became available on 1 October 2026. Swissmedic provides a transition until 1 April 2027 for linking to registered devices; the importer, not the CH-REP, owns that linkage obligation.

The representative should verify registration status and coordination, but the detailed upload, correction and fees workflow belongs to the separate registration page. Device-registration fees are charged per manufacturer rather than per CH-REP; do not treat them as the CH-REP service fee.

Although swissdamed device-registration charges are calculated per manufacturer (not per CH-REP), Swissmedic invoices a foreign manufacturer’s charges to its CH-REP. Agree who funds and reimburses these charges in the mandate; they are separate from the CH-REP service fee.

Appointment evidence checklist and change triggers

Request a documented appointment-readiness package, not merely a quote. An unresolved item is a hold point for the affected device group:

• Manufacturer legal name, establishment country, contracting signatory and intended Swiss launch date.
• Product families, intended purposes, MDR/IVDR or legacy route, class, EMDN where available, and generic-device-group boundaries.
• Declarations of conformity, certificates and expiry/transition evidence if applicable; technical-documentation access arrangement.
• Per-UDI-DI inventory, Swiss labelling/IFU mock-ups, CH-REP address display and importer list.
• CHRN/Actors status, proposed mandate validity, swissdamed device-registration owner, PRRC contact and vigilance escalation tree.

Reassess the mandate when a generic device group is added, the manufacturer or legal status changes, certificates lapse, a legacy-device condition is lost, a serious incident triggers immediate registration, or representation is transferred. Swissdamed supports mandate transfers, but transferred records and labelling must be reconciled. The 1 October 2026 release also automatically marks mandates outside their recorded validity period as “not valid”; a signed agreement alone is not enough to assume current database status.

Next safe action and related processes

First establish the manufacturer’s domicile and precise device route. Then build a group-by-group mandate and label matrix, check the proposed representative’s CHRN and documentation/vigilance capacity, and only then set a Swiss launch date. For detailed filing steps use the Swissmedic registration service; for product-by-product conformity routes use Swiss medical-device certification and route guidance; for the EU representative’s separate jurisdiction use the EU MDR authorised-representative service.

Official regulatory sources

• Swissmedic — medical devices FAQ / MedDO and IvDO
• Swissmedic — Economic Operators CH, v7.0, 1 May 2026
• Swissmedic — CH-REP symbol and address
• Swissmedic — CHRN economic-operator registration
• Swissmedic — mandatory device registration, 1 July 2026
• Swissmedic — importer links, 1 October 2026
• Swissmedic — swissdamed releases
• Swissmedic — combination products interpretation
• Swissmedic — who registers mandated devices
• Swissmedic — registration fee and invoicing

Frequently asked questions