Swiss CH‑REP Cost Calculator
Estimate annual CH‑REP costs based on coverage, portfolio complexity, and response SLA. Then request quotes from vetted providers.
Request Quotes Do I Need One?Cost Estimator
Use the inputs below to estimate a realistic annual range. This is a planning estimate; providers will quote final pricing.
What Drives Pricing?
- Coverage: MedDO vs IvDO vs both.
- Device class: Higher classes typically require more oversight.
- Portfolio size: More products increase review scope.
- Support scope: Basic CH‑REP vs CH‑REP + compliance support.
- Response SLAs: Faster SLAs typically cost more.
What’s Included in Typical Plans?
Most CH‑REP services include representation in Switzerland, documentation availability, and regulatory communications. Some providers bundle vigilance support or regulatory updates.
CH‑REP vs EU AR vs PRRC (Quick Comparison)
CH‑REP: Swiss legal entity appointed by non‑Swiss manufacturers under MedDO/IvDO.
EU AR: EU/EEA legal entity appointed by non‑EU manufacturers (MDR/IVDR Article 11).
PRRC: Qualified person responsible for compliance inside the manufacturer or AR organization (MDR/IVDR Article 15).
Key point: CH‑REP/EU AR are organizations; PRRC is a person.
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Request QuotesThis calculator provides planning estimates only and does not constitute legal advice. Cruxi is a marketplace/matching service; we are not a law firm. See our Privacy Policy.