EU Authorised Representative (EU-REP) – Compliance Globally
Official EU Authorised Representative (EU-REP / EC-REP) Services
Under EU General Product Safety Regulation (GPSR 2023/988) and EU MDR 2017/745, non-EU manufacturers MUST appoint an Authorised Representative physically established in the European Union. We provide official statutory representation, EU physical packaging address, and technical dossier archiving.
Compulsory GPSR 2026 Mandate
Official EU Physical Address for Labels
10-Year Technical File Archiving
National Market Surveillance Liaison
EU Regulatory Desk Active
EU-REP Mandate Desk
Registered offices in Germany and the Netherlands serving as your statutory legal entity across all 27 EU Member States.
Transparent European Market Packages
Full conformity with EU Regulations, direct representation, and guaranteed regulatory acceptance across all 27 Member States.
/ yr
Standard non-food consumer goods, Amazon/marketplace sellers.
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Statutory EU-REP Mandate Agreement -
Official EU Address for Product Packaging -
Technical Dossier Digital Vault Storage -
Market Surveillance Authority Liaison
/ yr
CE-marked electronics, machinery, and commercial equipment.
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LVD, EMC, RED & Machinery Representation -
EU Declaration of Conformity (DoC) Verification -
Rapid Incident / Recall Notification Support -
Annual Compliance Review & Certificate
/ yr
Medical devices (MDR), IVDs, and high-risk PPE equipment.
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Official EC-REP for EU MDR / IVDR -
EUDAMED Actor Liaison & Mandate -
PRRC Regulatory Oversight Integration -
24/7 Priority Competent Authority Defense
Mandatory European Documentation & Dossiers
Ensure smooth market entry and customs clearance across the EU Single Market.
EU Declaration of Conformity (DoC)
Signed declaration referencing all applicable EU directives and harmonised standards.
Technical Construction File (TCF)
Product schematics, test reports, risk assessment, and user manuals.
Product Labeling Mockups
Packaging artwork showing manufacturer details, CE mark, and EU-REP address space.
ISO 9001 / 13485 Certificate
Quality management system certificate (mandatory for medical and high-risk devices).
Conformity & Market Access Roadmap
Structured European compliance verification from technical file review to official market release.
Mandate Execution
Sign the statutory EU Authorised Representative mandate agreement defining roles and liabilities.
Dossier Verification
Our technical experts review your Technical File and test reports for EU regulatory completeness.
Labeling Approval
Affix our official EU-REP address and contact details to your packaging and user manuals.
Continuous Vigilance
Maintain technical files for 10 years and represent your brand before all 27 EU member states.
Frequently Asked Questions
Key regulatory guidance covering EU-REP mandates, CE marking directives, and EUDAMED requirements.
Is an EU Authorised Representative legally mandatory in 2026?
Yes. Under the EU General Product Safety Regulation (GPSR – Regulation (EU) 2023/988), which is enforced across all EU member states, non-EU businesses cannot sell products in the EU or on marketplaces like Amazon without an economic operator established in the EU.
Can the EU-REP be held liable for product non-compliance?
Under the GPSR and MDR, the EU Authorised Representative is legally responsible for verifying that the technical documentation exists and liaising directly with market surveillance authorities.
What address appears on our product packaging?
Our official registered corporate address in Germany or the Netherlands, formatted with our registered EU-REP designation.