European
Compliance Platform
European
Compliance Platform
Non-EU manufacturers must appoint an EU-based Authorised Representative under MDR, IVDR, GPSR, RED and other regulations before placing products on the EU market. Submit one request — ECP matches you to EAR providers covering your regulation and product category.
Any manufacturer established outside the European Union who places regulated products on the EU market must appoint an EU Authorised Representative (EU AR or EAR). The AR is your legal point of contact with EU market surveillance authorities and must be established in an EU Member State.
The requirement is not optional — without an appointed AR, products from non-EU manufacturers cannot legally be placed on the EU market under the relevant regulation.
| Regulation | Requirement | Scope |
|---|---|---|
| MDR 2017/745 | Mandatory — Article 11 | All medical devices from non-EU manufacturers |
| IVDR 2017/746 | Mandatory — Article 11 | All IVD devices from non-EU manufacturers |
| GPSR 2023/988 | Mandatory from Dec 2024 — Article 16 | All consumer products sold in EU (incl. online) |
| RED 2014/53/EU | Common practice / may be required | Radio equipment without EU-based importer |
| AI Act 2024/1689 | Mandatory for high-risk AI systems | Non-EU providers of high-risk AI |
| Toy Safety / PPE | Mandatory for non-EU manufacturers | Toys and PPE products |
The EU AR registers the manufacturer in EUDAMED or other EU databases, holds copies of technical documentation and Declaration of Conformity, acts as legal contact for market surveillance authorities, cooperates on recalls and vigilance reports, and is named on the product label (for MDR/IVDR).
Terms of service, liability scope, responsiveness and regulatory expertise vary significantly between EAR providers. The AR carries legal responsibility and must be reachable by authorities — choosing based on price alone is a risk.
Describe your company location, product category, applicable regulation, number of products and any specific requirements. ECP routes your request to EAR providers with matching scope and experience. You receive responses with service terms and next steps — without searching directories or negotiating with providers who don't cover your regulation.