Your EU Authorised Representative & PRRC for MDR/IVDR medical devices

Services & pricing

EU Authorised Representative appointment priced by device risk class under MDR/IVDR. PRRC coverage is available as a separate add-on.

Request scope check

MDR Class I · IVDR Class A

from €2,700/ year

EU Authorised Representative appointment for lower-risk devices.

Compliance review before appointment
Written mandate
EUDAMED registration
Document availability & authority liaison
Annual renewal

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MDR Class IIa/IIb · IVDR Class B/C

from €3,000/ year

EU Authorised Representative appointment for medium-risk devices.

Everything in Class I / A
Technical documentation review
Risk management file review

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MDR Class III · IVDR Class D

from €3,500/ year

EU Authorised Representative appointment for the highest-risk devices, including implantables and Class D IVDs.

Everything in Class IIa/IIb / B/C
Extended documentation & evidence review
Priority authority liaison

Combination products and non-standard scopes quoted separately.

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Add-on, all classes

from €4,000/ year

Qualified PRRC permanently and continuously available under Article 15(6) - priced separately from the EAR fee above. Depends on the number of product groups.

See PRRC details Request PRRC quote

EAR pricing depends on the number of product families and documentation readiness, confirmed after a free compliance review before any mandate is signed. PRRC pricing depends on the number of product groups.

Check whether you need an EU Authorised Representative

Tell us your device type, class and where your company is established. We will qualify the next step before any mandate is signed.

Free eligibility check