European
Compliance Platform
European
Compliance Platform
From medical devices to consumer products, the obligation to appoint an EU Authorised Representative has expanded significantly. This guide covers every major EU regulation requiring an AR, what the role entails, and how to find the right provider across EU, Switzerland, and the UK.
An EU Authorised Representative (EU AR) is a natural or legal person established in the European Union who is designated by a non-EU manufacturer to act on their behalf in relation to specific regulatory obligations under EU legislation.
The EU AR is not a distributor, importer, or logistics partner — it is a legal and regulatory role with defined responsibilities and legal liability. The AR is named in the EU Declaration of Conformity, on the product label (where required), and in the relevant EU databases (e.g. EUDAMED for medical devices).
The core purpose of the EU AR is to give EU regulatory authorities a legal contact point established in the EU — someone they can reach to discuss compliance, request documentation, or take enforcement action when needed.
| Regulation / Directive | AR Requirement | Key Obligation |
|---|---|---|
| MDR 2017/745 (medical devices) | Mandatory — Article 11 | Named in DoC and on label; EUDAMED registration; regulatory contact for authorities |
| IVDR 2017/746 (IVD devices) | Mandatory — Article 11 | Same as MDR; also assists with EUDAMED device registration |
| GPSR 2023/988 (general product safety) | Mandatory from 13 Dec 2024 — Article 16 | EU Responsible Person for all consumer products sold online or offline in EU |
| PPE Regulation 2016/425 | Not explicitly mandatory but commonly appointed | Regulatory contact; may take on importer obligations |
| Machinery Regulation 2023/1230 | Authorised representative may be designated | Can sign DoC; regulatory contact |
| Radio Equipment Directive (RED) | Not explicitly mandatory but common practice | Regulatory contact in EU |
| Toy Safety Directive | Mandatory for non-EU manufacturers | Named in technical documentation; regulatory contact |
European Union — Covers all 27 EU member states + Norway, Iceland, Liechtenstein (EEA). Must be established in the EU. Required under MDR, IVDR, GPSR, and others.
Switzerland — Swiss Authorised Representative. Required for medical devices under Swiss MedDO and other Swiss product legislation. Must be established in Switzerland. Separate from EU AR.
United Kingdom — UK Responsible Person. Required for Great Britain (England, Scotland, Wales) under UK MDR 2002 and other UK product legislation. Must be established in UK. Separate from EU AR.
Some regulatory service companies can act in all three roles. However, verify they are genuinely established in each jurisdiction — not simply acting through a sub-contractor without a real presence in that territory.
Under MDR Article 11(3) and IVDR Article 11(3), the EU AR takes on the following obligations alongside the manufacturer:
Under the General Product Safety Regulation (GPSR) 2023/988, the EU Responsible Person (acting as the EU AR equivalent) must:
This applies to all consumer products — toys, electronics, household goods, clothing, sports equipment — not just CE-marked or regulated categories.
The AR must be a legal entity established in the EU with a registered address — not simply a virtual office or mailbox. In the event of market surveillance or enforcement action, authorities must be able to reach the AR and take legal action if necessary.
An AR for a Class III implantable device needs deep MDR knowledge. An AR for general consumer goods under GPSR needs a different profile. Match the provider's expertise to your product and regulatory framework.
The AR must be reachable and responsive when authorities contact them — including evenings and weekends in urgent situations. Ask about their incident response process and availability.
Under MDR/IVDR, the AR must have access to your technical documentation and be able to provide it to authorities within the required timeframe. Ensure your AR arrangement includes a clear protocol for documentation access.
Review mandate agreements carefully: scope of devices covered, termination notice period, liability allocation, and what happens if the AR company ceases operations or loses regulatory status.
The formal basis for the EU AR relationship is a written mandate agreement between the manufacturer and the AR. For MDR/IVDR devices, the mandate must be in place before the device is placed on the EU market.
A complete mandate agreement should specify:
ECP connects non-EU manufacturers with vetted EU AR providers across medical devices (MDR/IVDR), consumer products (GPSR), and other regulated categories. One request — multiple qualified proposals.
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