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

Services & pricing

EU Authorised Representative appointment priced by device risk class under MDR/IVDR. External PRRC services are available separately for manufacturers represented by another Authorised Representative.

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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Separate service

from €4,000/ year

External PRRC permanently and continuously at your disposal under Article 15(2), for micro and small manufacturers represented by another Authorised Representative. 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. Before you sign a mandate, we tell you what the next step is.

Free eligibility check