EU Authorized Representative Cost Calculator
Estimate annual EU Authorized Representative costs based on coverage, portfolio complexity, and response SLA. Then request quotes from vetted providers.
Request Quotes Do I Need One? What is EC Rep? Device class finderEU AR pricing varies by regulation (MDR vs IVDR vs both), device class, portfolio size, and support scope (basic representation vs vigilance and compliance). Use this as a planning guide; final quotes depend on your mandate and provider.
Cost Estimator
Use the inputs below to estimate a realistic annual range. This is a planning estimate; providers will quote final pricing. Not sure of your device class? Use our MDR/IVDR device class finder. Ready to appoint? Check our EU AR mandate readiness checklist.
What Drives Pricing?
EU AR costs depend on several factors. The calculator applies typical ranges; your quote may be higher or lower depending on provider and mandate scope.
- Coverage: MDR only, IVDR only, or both—IVDR and dual coverage often command a premium.
- Device class: Higher classes (IIb, III, IVD C/D) usually mean more oversight and documentation handling.
- Portfolio size: More products or families increase the volume of representation and potential vigilance support.
- Support scope: Basic AR (mandate, representation, documentation availability) vs AR + vigilance and reporting vs AR + full compliance support.
- Response SLAs: Faster turnaround typically costs more.
- Languages and EUDAMED: Multi-language support and EUDAMED registration/maintenance may be included or quoted separately.
What’s Included in Typical Plans?
Most EU Authorized Representative services include:
- Written mandate: Contract defining the scope of representation between you and the AR.
- Representation: The AR acts as your legal representative in the EU/EEA for MDR/IVDR purposes.
- Documentation: Verifying availability of the EU declaration of conformity and technical documentation; making them available to authorities on request.
- EUDAMED: AR registration and SRN; support with device registration where the AR is involved.
- Authorities: Cooperating with competent authorities and forwarding requests to you.
- Vigilance (if in scope): Support with serious incident reporting and field safety corrective actions; confirm with the provider.
Some providers bundle regulatory updates, PMS support, or PRRC services. Compare scope when requesting quotes.
EU AR vs CH‑REP vs PRRC (Quick Comparison)
EU AR: EU/EEA legal entity appointed by non‑EU manufacturers (MDR/IVDR Article 11).
CH‑REP: Swiss legal entity appointed by non‑Swiss manufacturers under MedDO/IvDO.
PRRC: Qualified person responsible for compliance inside the manufacturer or AR organization (MDR/IVDR Article 15).
Key point: EU AR/CH‑REP are organizations; PRRC is a person.
FAQ
How often do I pay for EU AR services?
Most providers quote on an annual basis (retainer or fixed fee per year). Some offer monthly or quarterly billing. Confirm payment terms when you request quotes.
How long is a typical EU AR mandate?
Mandates are typically one to three years, with renewal options. Termination and handover (e.g. to another AR) must be agreed in the contract. Check notice periods and any obligations on termination.
What currency do EU AR providers quote in?
Many EU-based providers quote in euros (€). The calculator uses € as a typical currency. Confirm currency and whether prices are exclusive or inclusive of VAT when you request quotes.
Ready for formal quotes?
Cruxi matches you with vetted EU Authorized Representatives. Compare coverage, experience, and pricing in one place.
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.