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
CH-REP mandate structuring and review and Swiss market-entry counsel under the MepV for manufacturers without a Swiss presence: drafting and reviewing the mandate agreement, advising on the representative’s duties, the Swissmedic-registration and vigilance-correspondence framework, and coordination with the EU authorized representative. The firm structures and advises on the arrangement; it does not act as the representative.
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.