EU Authorized Representative: MDR & IVDR Requirements
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Medical device manufacturers located outside the European Union must appoint an EU Authorized Representative (AR) to sell their devices on the EU market.
Video guide
EU Authorized Representatives: Article 11
Learn when an EU authorized representative is needed and what MDR and IVDR Article 11 require.
Open video pageTranscript (English)
Do you need an EU authorized representative? If you're a manufacturer outside the EU, yes. Without one, your device can't be placed on the EU market at all. The rule is short. For each generic device group, you designate one sole authorized representative, established in the EU. And the mandate is valid only once the representative accepts it in writing. Medical devices and IVDs follow the same rule. At minimum, the mandate makes your representative check that your declaration and technical documentation have been drawn up, keep copies for authorities for at least 10 years, or 15 for implants, register in EUDAMED, and pass on complaints immediately. And the stakes are real. If a non-EU manufacturer fails its obligations, the representative is legally liable for defective devices, jointly and severally with the manufacturer. Start with three things. One: sign a written mandate for each device group. Two: give your representative your latest technical documentation. Three: put its name and address on your label. A sole representative per device group. Pure Global covers registration, in-country representation, quality systems, audits and cybersecurity, in more than 30 markets. Visit pureglobal.com.
EU Authorized Representative: who needs one?
A manufacturer established outside the EU/EEA generally appoints a sole Authorized Representative for the relevant generic device group before placing covered devices on the EU market. Under MDR or IVDR Article 11, the EU Authorized Representative must be established in the applicable territory and accept a written mandate setting out the required tasks.
The representative is a distinct economic operator, not a Notified Body or product approval authority. The manufacturer retains its own obligations. Use the MDR, IVDR and MDCG 2022-16 guidance to define the actual arrangement.
What does the representative verify and maintain?
| Task area | Practical evidence | Boundary |
|---|---|---|
| Mandate and device scope | Legal manufacturer, device groups and accepted responsibilities | Commercial distribution alone is not an Article 11 mandate |
| Conformity verification | Declaration of Conformity, technical documentation and applicable assessment | Does not replace the manufacturer’s conformity work |
| Registration | Applicable actor/device registration and verification | EUDAMED entry is not CE certification |
| Record availability | Accessible current documentation and certificates | Define retention, access and updates contractually |
| Authorities and safety | Requests, complaints, noncompliance escalation and corrective-action cooperation | Manufacturer vigilance duties still apply |
The mandate cannot transfer every manufacturer duty to the representative. Confirm the nondelegable tasks in Article 11, including the relationship to the manufacturer's quality, risk, clinical/performance and technical-documentation obligations. The representative must have a qualified PRRC permanently and continuously at its disposal.
Liability and termination need specific treatment
MDR/IVDR Article 11 includes conditions under which the representative can be jointly and severally liable with the manufacturer for defective devices when the manufacturer has not met the relevant obligations. Do not describe the role as either unlimited product liability or a purely administrative mailbox. Define insurance, cooperation, access to evidence and escalation while preserving the statutory responsibilities.
If noncompliance requires ending the mandate, follow the notification and handover requirements. A change of representative should address dates, labeling, documents, authority communications and record access under Article 12. Avoid leaving the portfolio without valid representation or creating conflicting mandates for the same scope.
EU representation versus UK and Switzerland
An EU mandate does not automatically provide a UK Responsible Person or Swiss CH-REP. Assess each territory and its registration, labeling and safety-reporting duties separately, even if one service organization offers all three.
Before appointing an AR, reconcile the device scope, CE conformity plan, evidence gaps, GSPR mapping and PMS arrangements. Pure Global can provide representation and coordinate the wider program within a defined mandate and service scope.
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Frequently asked questions
No. Distribution does not itself create the Article 11 role. The eligible representative must accept a written mandate, perform the required tasks and maintain the necessary documentation, expertise and availability.
No. MDR and IVDR Article 11 specify tasks that cannot be delegated through the mandate. The manufacturer retains its own quality, evidence, conformity and lifecycle obligations alongside the AR’s distinct duties.
No. EU representation, UK Responsible Person and Swiss CH-REP are separate legal roles with different territorial requirements. Coordinate them explicitly rather than treating one appointment as a universal European authorization.
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