Do I Need a Swiss Authorized Representative (CH‑REP)?
Use the quick eligibility tool below, then review the criteria and responsibilities. If you need a CH‑REP, Cruxi can match you with vetted providers.
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Answer four questions for a directional view. This is not legal advice — use it to decide whether to consult a CH‑REP provider.
Core Criteria (MedDO + IvDO)
Non‑Swiss manufacturers must appoint a Swiss Authorized Representative (CH‑REP) before placing devices on the Swiss market. This applies to medical devices and IVDs under MedDO and IvDO.[1][2]
Not sure if you’re placing on the Swiss market?
Use this helper to check if your activity is considered “placing on the market.”
Not sure if you’re the manufacturer?
This helper clarifies whether you are the legal manufacturer under Swiss requirements.
What a CH‑REP is responsible for
A CH‑REP is designated by written mandate and acts as the contact point for Swiss authorities. Swissmedic guidance explains how the CH‑REP is identified and how contact details appear on labeling and documentation.[1][2]
CH‑REP vs EU AR vs PRRC (Quick Comparison)
Swiss Authorized Representative (CH‑REP): A legal entity in Switzerland appointed by non‑Swiss manufacturers under MedDO/IvDO.
EU Authorized Representative (EU AR): A legal entity in the EU/EEA appointed by non‑EU manufacturers under MDR/IVDR Article 11.
PRRC: A qualified person responsible for regulatory compliance inside the manufacturer or AR organization (MDR/IVDR Article 15).
FAQ
Is an EU Authorized Representative valid for Switzerland?
No. Switzerland requires a Swiss Authorized Representative (CH‑REP) for non‑Swiss manufacturers placing devices on the Swiss market.
Do Swiss manufacturers need a CH‑REP?
No. Swiss manufacturers do not need a CH‑REP for Swiss market access.
Do importers/distributors need a CH‑REP?
Not unless they also act as a manufacturer.
Ready to get quotes?
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[1] Swissmedic — Swiss authorised representative (CH‑REP).
[2] Swissmedic FAQ — Authorized representative (MedDO/IvDO references).
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