GAWEL LEGAL

CH-REP advisory

GAWEL Legal structures the Swiss authorized representative (CH-REP) mandate for device and IVD makers without a Swiss seat, for a fixed fee. The MepV or the IvDV requires the mandate in writing before the products reach the Swiss market; the fixed fee covers drafting it, allocating the representative's duties and aligning it with the client's EU authorized-representative mandate, while the operational CH-REP role stays with a specialized provider.

Discuss a CH-REP mandate View scope
The Swiss representative mandate
Manufacturer
Without a Swiss seat
Written mandate
Duties and documentation
CH-REP provider
Operational representative

GAWEL Legal structures and advises on the mandate; it does not act as the representative.

Who this is for

  • Non-Swiss medical-device and IVD manufacturers placing products on the Swiss market
  • Manufacturers selecting or negotiating with a CH-REP service provider
  • Companies coordinating their EU authorized representative with the Swiss mandate

Scope

  • Mandate drafting and review:
    the written CH-REP mandate a manufacturer without a Swiss seat must have in place before its devices may be placed on the Swiss market (Art. 51 MepV)
  • Duty allocation:
    structuring the representative's rights and obligations, which the MepV aligns with the EU authorized-representative role under Art. 11 MDR, and their split between manufacturer, CH-REP and importer
  • EU coordination:
    aligning the CH-REP mandate with the client's EU authorized-representative mandate (Art. 11 MDR) so duties and documentation line up across both markets
  • Provider selection and negotiation:
    reviewing and negotiating terms with the specialized service provider that performs the operational CH-REP role
  • Swissmedic interface:
    counsel on the Swissmedic registration (Art. 55 MepV) and the vigilance-reporting framework the representative operates within
  • Portfolio structuring:
    multi-class and IVD portfolio mandates, and combined Swiss and EU representative arrangements

How the work proceeds

  1. Structure The arrangement is scoped for the Swiss market and the relevant device classes.
  2. Draft The CH-REP mandate agreement and its allocation of duties are drafted or reviewed.
  3. Coordinate The mandate is coordinated with the client's EU authorized representative.
  4. Advise The representative's MepV duties and the Swissmedic interface are covered.
  5. Hand over The appointed CH-REP provider performs the operational role; GAWEL Legal remains legal counsel.

Fees

Fixed-fee mandate structuring

CH-REP mandate structuring and review as a one-off fixed fee, for a single device class or a multi-class or IVD portfolio. The operational CH-REP role is performed by a specialized provider on a recurring annual fee; GAWEL Legal provides the initial legal advice and documentation. Broader MDR/IVDR support is available on a monthly retainer with fixed-fee modules.

Questions

Does GAWEL Legal act as the operational CH-REP?
No. The CH-REP is a regulated operational role under the MepV that carries ongoing vigilance, market-surveillance and document-availability duties and is subject to Swissmedic inspection, functions typically performed by specialized regulatory service providers rather than by legal counsel. GAWEL Legal provides legal advice: structuring and drafting the mandate, advising on its duties, and coordinating it with the EU representative.
Why is a CH-REP needed?
Since the mutual recognition agreement with the EU stopped covering medical devices, Switzerland and the EU treat each other as third countries for medical-device market access, so a manufacturer domiciled outside Switzerland must appoint a Swiss authorized representative to place devices on the Swiss market (Art. 51 MepV). The CH-REP is the Swiss counterpart to the EU authorized representative.
How does the CH-REP relate to the EU authorized representative?
They are parallel roles in two markets. The EU authorized representative covers the EU market; the CH-REP covers Switzerland. GAWEL Legal coordinates the two mandates so duties and documentation line up across both.
What must the CH-REP mandate itself contain?
The mandate must be agreed in writing (Art. 51 MepV), and its scope has to cover the representative's rights and obligations, which the MepV aligns with the EU authorized-representative role under Art. 11 MDR: verifying key documentation, keeping it available for the authorities, and serving as the contact for vigilance correspondence. In practice the drafting questions are the allocation of those duties against the manufacturer and the importer, liability and termination. GAWEL Legal drafts and reviews that allocation.
What must the CH-REP marking on a label show, and where?
The name and address of the Swiss authorized representative, on the label. The MepV makes the product information, meaning the label and the instructions for use, follow Annex I Chapter III of the EU MDR (Art. 16 Abs. 1 MepV). Through that reference, Section 23.2(d), Annex I MDR requires the representative's name and the address of its registered place of business on the label of a device whose manufacturer has no seat in Switzerland; the transitional option of putting those details on a document accompanying class I devices and procedure packs ended on 31 July 2023 (Art. 104a bis MepV). The ordinance prescribes the content, not a symbol: symbols defined in technical standards may replace wording (Art. 16 Abs. 2 MepV), which is the basis on which the boxed CH-REP symbol is placed beside the representative's details. For an in vitro diagnostic the same rule runs through the IvDV (Art. 15 IvDV).
What does a CH-REP do once appointed?
It handles the formal and safety-related matters of placing the device on the Swiss market (Art. 51 Abs. 2 MepV), with rights and duties that follow Art. 11 of the EU MDR (Art. 51 Abs. 3 MepV): verifying that the declaration of conformity and the technical documentation exist, keeping copies available for Swissmedic or, where the mandate so provides, ensuring the manufacturer delivers the documentation to Swissmedic within seven days of a request (Art. 51 Abs. 3bis MepV), registering with Swissmedic, which assigns the Swiss single registration number, the CHRN (Art. 55 MepV), and passing complaints and incident reports on to the manufacturer. It is responsible for reporting serious incidents and field safety corrective actions in Switzerland to Swissmedic and submits trend reports on its own initiative; the transfer of these duties from the manufacturer must be agreed in writing in the mandate (Art. 66 Abs. 2bis MepV). It must also have permanent access to a person responsible for regulatory compliance (Art. 52 MepV). A change of representative follows Art. 12 of the EU MDR (Art. 51 Abs. 4 MepV).
What does the advisory cost, and what does it not include?
Mandate structuring and review is a one-off fixed fee, for a single device class or a multi-class or IVD portfolio. The fee does not include the operational CH-REP role itself, which a specialized provider performs on a recurring annual fee; GAWEL Legal provides the initial legal advice and documentation and continues as legal counsel.
Does an in vitro diagnostic need a CH-REP as well?
Yes. In-vitro diagnostics fall under the IvDV rather than the MepV (Art. 1 IvDV), and the IvDV carries the same duty: a manufacturer without a seat in Switzerland may place its products on the Swiss market only once it has mandated a person with a seat in Switzerland, in writing (Art. 44 Abs. 1 IvDV). The representative's rights and duties follow Art. 11 of the EU IVDR (Art. 44 Abs. 3 IvDV), the seven-day documentation rule and the change-of-representative rule mirror the MepV (Art. 44 Abs. 4 and 5 IvDV), and the representative must have permanent access to a person responsible for regulatory compliance (Art. 45 IvDV). One mandate can cover a mixed device and IVD portfolio.

Related articles

Last updated: 4 October 2026

Discuss your matter

Briefly describe the matter and the legal advice you need.

Discuss a CH-REP engagement