The mandate and liability
What the AR agreement covers.
Your EU Authorised Representative & PRRC for MDR/IVDR medical devices
FDA clearance or approval does not give access to the EU market. US manufacturers need CE marking under the MDR or IVDR and an EU Authorised Representative - a role with more responsibility than the FDA US Agent.
| FDA US Agent | EU Authorised Representative | |
|---|---|---|
| Legal basis | 21 CFR 807.40 | Article 11 MDR / IVDR |
| Main function | Communication link with the FDA | Verifies documentation, keeps it available, registers in EUDAMED, cooperates on corrective action |
| On the label | No | Yes - name and registered address |
| Liability for defective devices | No | Joint and several with the manufacturer, if the manufacturer has not complied with Article 10 |
No. Devices placed on the EU market need CE marking under the MDR or IVDR, with an EU Authorised Representative for manufacturers outside the EU.
No. The EU role includes documentation verification, EUDAMED registration, cooperation on corrective action, presence on the label and potential joint liability.
Yes, if it is established in the EU and accepts the mandate in writing with the Article 11 tasks.
What the AR agreement covers.
Label requirements for non-EU manufacturers.
Economic operator registration.
Note: This guide provides general information about Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), not legal advice. Specific obligations depend on your device and company structure. Last reviewed 30 September 2026.
Tell us your device type, class and where your company is established. We will qualify the next step before any mandate is signed.