EU Authorized Representative Services — Your Statutory EU MDR Representative
Sub-headline: RABT Global provides EU authorized representative services for non-EU medical device manufacturers under EU MDR 2017/745 and EU IVDR 2017/746. Appoint RABT Global as your EU MDR compliance representative today.
Statutory EU Authorized Representative services for medical devices — compliant, responsive, and fully registered in the EU.
EU authorized representative services are a legal requirement for any non-EU/EEA medical device manufacturer wishing to place CE-marked devices on the European market under EU MDR 2017/745 and EU IVDR 2017/746. Without an appointed EU Authorized Representative (EU AR), non-EU manufacturers cannot legally market their devices in the EU — regardless of CE marking status.
At RABT Global, our EU authorized representative services for medical devices provide the statutory representation required by EU MDR 2017/745 Article 11 and EU IVDR 2017/746 Article 11. As your appointed EU MDR compliance representative, RABT Global registers your devices in EUDAMED, acts as the primary point of regulatory liaison with EU competent authorities and Notified Bodies, and ensures that your obligations under EU MDR and IVDR are met on an ongoing basis.
Our European authorized representative services are provided by qualified regulatory professionals who understand both the obligations of the EU Authorized Representative role and the broader EU MDR compliance requirements your devices must meet. Appointing RABT Global as your authorized representative EU MDR partner gives you regulatory-grade EU representation combined with access to our full EU MDR compliance advisory services.
EU Authorized Representative Obligations Under EU MDR
| EU AR Obligation | What RABT Global Does |
|---|---|
| Registration in EUDAMED | Register as EU AR and register all your devices in the EUDAMED database |
| Declaration of Conformity | Hold a copy of the manufacturer’s Declaration of Conformity |
| Technical Documentation | Hold and provide access to technical documentation on request from competent authorities |
| Notified Body liaison | Act as the contact point for your Notified Body where required |
| Competent Authority liaison | Respond to competent authority requests, questions, and serious incident reports |
| Serious incident reporting | Report serious incidents and Field Safety Corrective Actions (FSCA) to relevant authorities |
| UDI management | Support UDI assignment and EUDAMED registration for applicable devices |
| Post-market surveillance | Liaise on PMS obligations and receive regulatory communications on your behalf |
What is an EU Authorized Representative for Medical Devices?
An EU Authorized Representative (EU AR) is a legally appointed natural or legal person established within the EU who acts on behalf of a non-EU/EEA medical device manufacturer in relation to that manufacturer’s obligations under EU MDR 2017/745 and/or EU IVDR 2017/746. EU law requires that every non-EU manufacturer placing CE-marked medical devices on the EU market must appoint an EU Authorized Representative. The EU AR is registered in EUDAMED and acts as the primary regulatory contact within the EU.
EU Authorized Representative — FAQs
A: Any manufacturer of medical devices or in vitro diagnostic medical devices who is established outside the EU/EEA and wishes to place CE-marked devices on the EU market under EU MDR 2017/745 or EU IVDR 2017/746 is legally required to appoint an EU Authorized Representative. This applies to all device classes and all non-EU countries — including UK manufacturers post-Brexit.
A: An EU Authorized Representative (EU AR) is a regulatory compliance representative who acts on behalf of the non-EU manufacturer in dealings with EU competent authorities, EUDAMED, and other regulatory obligations. A Notified Body (NB) is an independent conformity assessment body that audits and certifies devices requiring third-party assessment (Class IIa, IIb, III under EU MDR). RABT Global provides EU AR services; we can also support your Notified Body selection and audit preparation.
A: Yes. RABT Global provides EU authorized representative services for medical devices across all classes — Class I (self-certified), Class IIa, Class IIb, and Class III under EU MDR 2017/745, and Class A, B, C, and D under EU IVDR 2017/746.
A: Under EU MDR, your EU AR cannot resign without giving you reasonable notice, and the termination must be notified to the relevant competent authority. RABT Global provides a managed transition service if you are changing your EU AR — ensuring continuity of your regulatory status and uninterrupted market access.
Appoint RABT Global as Your EU Authorized Representative
Statutory EU MDR and IVDR authorised representative services for non-EU medical device manufacturers. Regulatory-grade EU representation combined with full EU MDR compliance advisory support.