European Authorised Representative for Medical Devices & IVDs
Non-EU manufacturers must appoint an EU Authorised Representative (EC REP) to sell in the European Union. We act as your legal representative under MDR and IVDR, verify your documentation, register you in EUDAMED and handle communication with competent authorities.
What is a European Authorised Representative?
A European Authorised Representative, also called an EU Rep or EC REP, is a person or company established in the EU that a non-EU manufacturer appoints by written mandate to act on its behalf for regulatory tasks.
It is required by Article 11 of MDR 2017/745 and IVDR 2017/746. Without one, a non-EU manufacturer cannot obtain an SRN in EUDAMED, register devices or place them on the EU market. The representative's name and address must appear on your labels.
What your EU Authorised Representative does
The written mandate must cover at least these tasks, set out in MDR and IVDR Article 11(3).
| Task | What it means for you |
|---|---|
| Verify documentation | Checks that your EU Declaration of Conformity and technical documentation exist and that the right conformity assessment was carried out. |
| Keep copies available | Holds the technical documentation, DoC and certificates for competent authorities for the required retention period. |
| Registration | Meets EUDAMED registration duties and verifies that you have registered your devices and UDI data. |
| Authority requests | Provides documents and samples to competent authorities on request, in an official EU language. |
| Corrective actions | Cooperates with authorities on preventive and corrective actions to reduce risks from your devices. |
| Complaints & incidents | Forwards complaints and reports of suspected incidents from users and patients to you immediately. |
| Terminate if needed | Must end the mandate if you act against your MDR or IVDR obligations, and inform the authorities. |
How we become your EU Representative
A clear onboarding route from first contact to your devices being registered and on the market.
- 1
Scope & document review
Week 1We confirm your devices, classes and certificates and review your DoC and technical documentation.
- 2
Written mandate
Article 11(3)We sign a mandate agreement that defines our tasks and your obligations.
- 3
EUDAMED actor registration
SRNWe submit your actor registration and follow it through validation by the competent authority.
- 4
UDI & device registration
Basic UDI-DIWe help assign UDI and register your devices and certificates in EUDAMED.
- 5
Labelling update
ISO 15223-1We check that labels and IFU carry our name, address and the EC REP symbol.
- 6
Ongoing representation
LifecycleWe handle authority requests, forward complaints and incidents, and support vigilance and corrective actions.
What to check before you appoint an EU Rep
Our EU Representative services
EU Authorised Representative FAQs
Who needs a European Authorised Representative?
Any medical device or IVD manufacturer based outside the EU must appoint an EU Authorised Representative before placing devices on the EU market. This is required by Article 11 of both MDR 2017/745 and IVDR 2017/746.
What is an SRN and how do I get one?
The Single Registration Number (SRN) is your unique actor ID in EUDAMED. Non-EU manufacturers apply for it through EUDAMED, and the competent authority of the member state where the Authorised Representative is based validates the request. We handle the registration for you.
Is the Authorised Representative liable for my devices?
Yes. Under Article 11(5), the Authorised Representative is legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer if the manufacturer has not met its Article 10 obligations. This is why your AR must verify your documentation.
Do you provide product liability insurance?
No. MDR Article 10(16) requires manufacturers to have sufficient financial coverage for their potential liability, usually through product liability insurance. We do not provide insurance, but we can guide you on what cover to consider for your device class and market.
Do you provide UDI support?
Yes. We help assign Basic UDI-DI and UDI-DI, check UDI placement on labels, packaging and IFU, and register your devices in EUDAMED.
Can I change my EU Authorised Representative?
Yes. Article 12 sets out how to change: an agreement between the manufacturer, the outgoing and the incoming representative covering the end and start dates of the mandates, labelling updates and transfer of documents.
Need an EU Representative for your devices?
Send us your device list using the form below and we'll send you a quote for EC REP and EUDAMED registration.
