Swiss Authorized Representative (CH-REP) advisory.
A manufacturer outside Switzerland must appoint a Swiss authorized representative (CH-REP) to place medical devices on the Swiss market under the MepV. The firm structures that arrangement: drafting the CH-REP mandate, advising on its duties, and coordinating it with the EU authorized representative. The firm does not act as the operational CH-REP, a regulated service carrying vigilance and market-surveillance duties.
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.
What's included
- 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 specialised service provider that performs the operational CH-REP role; the firm advises, it does not take the role.
- Swissmedic interface: counsel on the registration and vigilance-correspondence framework the representative operates within; operational detail is confirmed against current guidance at engagement.
- Portfolio structuring: multi-class and IVD portfolio mandates, and combined Swiss and EU representative arrangements.
How it works
- Structure. The firm maps the CH-REP arrangement the client needs for the Swiss market and the relevant device classes.
- Draft. The firm drafts or reviews the CH-REP mandate agreement and its duty allocation.
- Coordinate. The firm aligns the mandate with the client's EU authorized representative (the mirror role).
- Advise. The firm advises on the representative's MepV duties and the Swissmedic interface.
- Hand over. The appointed CH-REP provider performs the operational role; the firm stays as counsel.
Indicative pricing
Fixed-fee mandate structuring
from CHF 6,500
CH-REP mandate structuring and review as a one-off fixed fee for a single device class; a multi-class or IVD portfolio mandate, or combined coordination with the EU authorized representative, from CHF 9,500. The operational CH-REP role is performed by a specialised provider on a recurring annual fee; the firm provides the one-off legal layer. Broader MDR/IVDR support is available from CHF 5,500 / month plus fixed-fee modules.
Indicative starting prices, net and exclusive of Swiss MWST (VAT) where applicable; final fee per written engagement letter.
Frequently asked questions
- Does the firm 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 specialised regulatory service providers, not a law firm. The firm provides the legal layer: structuring and drafting the mandate, advising on its duties, and coordinating it with the EU representative.
- Why is a CH-REP needed at all?
- Switzerland is treated as a third country for medical-device market access, so a manufacturer domiciled outside Switzerland must appoint a Swiss authorized representative to place devices on the Swiss market under the MepV (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. The firm 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. The firm drafts and reviews exactly that allocation.