EU Authorised Representative: Roles and Requirements
An EU Authorised Representative (EU AR or EC‑REP) is a natural or legal person established in the European Union who is formally appointed by a non‑EU manufacturer to carry out specified compliance tasks and act as the point of contact for EU authorities. The role is defined in the EU’s common product framework in Decision No 768/2008/EC and explained in the European Commission’s Blue Guide on the implementation of EU product rules.
Do you need an EU Authorised Representative?
If your company is established outside the EU and you place products on the EU market, sector legislation often requires appointing an EU AR. For example, MDR (EU) 2017/745 and IVDR (EU) 2017/746 mandate an AR in Article 11 for non‑EU manufacturers of medical devices and IVDs. For consumer products, the General Product Safety Regulation (EU) 2023/988 requires that a responsible economic operator in the EU be identifiable, which can be fulfilled by an authorised representative. The Commission’s “Your Europe” page on product compliance summarises these obligations.
What does an EU AR do?
The authorised representative’s delegated tasks are set out in the mandate and in applicable product laws. Typically they include:
- Verification tasks: checking that the product bears required markings and that an EU Declaration of Conformity has been drawn up, as described in the Blue Guide and “Your Europe” guidance on technical documentation and DoCs.
- Keeping the technical documentation available for competent authorities upon request. For medical devices, see MDR and IVDR Article 11(3)(b) and MDCG 2022‑16 guidance on AR obligations.
- Regulatory liaison: acting as the single contact point for market surveillance authorities for inspections, incident communications, and corrective actions in line with the GPSR.
- Post‑market support: coordinating vigilance reporting and facilitating field safety corrective actions where required by sector rules.
Consequences of not appointing an EU AR when required
- Market access blocked: customs holds and refusal to place products on the EU market.
- Enforcement actions: orders to withdraw, recall, or correct products and possible penalties by market surveillance authorities under the GPSR.
- Reputational damage and disruption to EU sales.
What must be in the written mandate?
The mandate is required to be in writing and must clearly define the tasks and limits of the AR in line with Decision No 768/2008/EC, the Blue Guide, and sector rules like MDR and IVDR. At a minimum, include:
- Identification of manufacturer and authorised representative, with EU address and contacts.
- Scope of tasks delegated, for example holding the technical file, verifying the DoC, and handling authority requests.
- Document access and retention, including how the AR will provide documents to authorities on request.
- Incident and vigilance procedures, including timelines for notifications and field actions.
- Liability, confidentiality, and termination arrangements, plus cooperation duties after termination.
How EaseCert helps as your EU contact
EaseCert provides one‑time fee, fast‑turnaround support for GPSR compliance and can act as your EU point of contact throughout the product lifecycle. Explore how to appoint an EU Responsible Person or Authorised Representative, set up EU Safety Gate registration, build a compliant technical file, use our risk analysis template, and follow labelling requirements for GPSR compliance. Ready to discuss your portfolio? Book a free 30‑minute consultation or contact our team.
Frequently Asked Questions
What is an EU Authorised Representative and where is it defined?
An EU AR is an EU‑based person appointed by a non‑EU manufacturer to perform specified compliance tasks and liaise with authorities, as defined in Decision No 768/2008/EC and described in the Commission’s Blue Guide.
What are the consequences of not having an EU AR when required?
Authorities may block market access, order withdrawal or recall, and impose penalties under the GPSR. You may also face customs holds and reputational damage.
How is the EU AR’s liability determined?
For medical devices and IVDs, the AR can be held jointly and severally liable with the manufacturer for defective products in line with MDR and IVDR Article 11. The Blue Guide also clarifies shared responsibilities among economic operators.
Is an EU AR the same as an importer or a responsible person under the GPSR?
No. These are distinct roles with different duties. The importer places products on the market and has separate obligations. Under the GPSR, a responsible economic operator must be identifiable for consumer products, which can be the AR when the manufacturer is outside the EU.
Where can I find official guidance and next steps?
Consult the Commission’s Blue Guide and “Your Europe” pages on product compliance. For practical implementation, review EaseCert’s technical file guide, labelling requirements, and our EU Safety Gate registration tutorial, then book a free consultation.