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. ECP is an independent routing platform — not a provider or consultancy of any kind. You deal directly with the provider you choose, on their terms.
GPSR has been mandatory since December 2024. If you sell consumer products in the EU without a Responsible Person, you are already non-compliant — this is not a future deadline.
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.
EU Authorised Representative (EC REP) is one of several representative roles required for market access. Depending on your product type, business model, and target markets, you may also need:
| Service | Description | Find a provider |
|---|---|---|
| GPSR Responsible Person | Required for general consumer products (not covered by sector-specific regulations) sold in the EU from December 2024 under Regulation (EU) 2023/988. | Find GPSR RP |
| EU Cosmetics Responsible Person | Mandatory for non-EU cosmetics brands under Cosmetics Regulation 1223/2009. Includes CPNP notification and product information file management. | Find Cosmetics RP |
| PRRC Services | Person Responsible for Regulatory Compliance (MDR/IVDR Art. 15) for medical device manufacturers who lack an in-house PRRC. | Find PRRC Provider |
| UK Representative (UK RP) | Separate UK Responsible Person required under UK MDR 2002 and UKCA marking rules for products sold on the GB market post-Brexit. | Find UK RP |
| REACH Only Representative | EU-based representative for non-EU manufacturers of chemical substances under REACH Regulation (EC) No 1907/2006. Takes on importer obligations and manages ECHA registration. | Find REACH OR |
| GDPR Article 27 Representative | Required for organisations outside the EU/EEA that process personal data of EU residents without EU establishment — GDPR (EU) 2016/679 Art. 27. | Find GDPR Rep |
| DSA Article 13 Legal Representative | Digital service providers (platforms, search engines, marketplaces) established outside the EU serving EU users must designate an EU legal representative under DSA Art. 13. | Find DSA Rep |
| VAT Fiscal Representative | EU VAT registration and fiscal compliance for non-EU businesses selling goods or services in EU member states. | Find VAT Fiscal Rep |
| WEEE / EPR Compliance | Registration in national WEEE registries, reporting obligations, and take-back compliance for producers and importers of electronics and packaging. | Find WEEE/EPR Provider |
| Swiss FADP Representative | Swiss data protection representative under Swiss FADP/nDSG Art. 14 for organisations outside Switzerland processing data of Swiss residents. | Find Swiss FADP Rep |
The EU Authorised Representative (EC REP) is not the same as a GPSR Responsible Person, PRRC, GDPR Art. 27 representative, DSA Art. 13 representative, or REACH Only Representative. Each role is defined by a different regulation and carries distinct legal obligations. Many ECP providers offer combined packages — submit your request specifying all needed roles.