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

EU Authorised Representative for medical devices (MDR/IVDR)

For medical device and IVD manufacturers established outside the EU, getEAR.eu can act as the EU Authorised Representative required under Article 11 of the MDR or IVDR before your device is placed on the EU market.

Check eligibility See pricing

This is not general regulatory consulting

Article 11 sets out a defined, EU-established role: an economic operator that verifies your conformity documentation, keeps it available to authorities, registers with EUDAMED, and acts as your EU contact point. We focus on doing that role properly rather than selling broad "MDR consulting."

Where your technical documentation, risk management file or clinical/performance evidence is not yet ready, we say so before signing a mandate - see Services & pricing for the compliance review options.

What's included

Compliance review before appointment
Written mandate meeting MDR/IVDR Article 11 requirements
EUDAMED registration as your Authorised Representative
Document availability for national competent authorities
Cooperation on corrective action and field safety notices
Annual renewal and ongoing compliance maintenance

How appointment works

Send your device type, intended purpose, classification and existing documentation
We run a compliance review: applicable route, technical documentation, evidence status
If ready, we issue a written mandate and register as your Authorised Representative in EUDAMED
If gaps exist, we tell you what is missing before any mandate is signed

Start eligibility check

Note: This page provides general information. Specific obligations depend on your device classification and applicable EU legislation.

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