Homepage Product Compliance Importing into the EU: Product Compliance is More than Test Reports

Importing into the EU: Product Compliance is More than Test Reports

Getting into the EU market now means far more than putting a CE logo on the box. CE is one part of a wider system of safety, cybersecurity, documentation, and post-market duties that vary by product type and features (wireless, software, AI, medical, etc.). Treat compliance as a process you build into development, not a one-time certificate.

CE and lab reports aren’t enough. See what EU importers need in 2025: technical file, risk assessment, AR/RP, GPSR duties, and post-market controls.

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Table of Contents

What we cover

00:00:13 – Introduction: why “CE-only” thinking is risky in 2025, who this affects (brand owners, importers, DTC sellers), and how to approach compliance as an ongoing process.
00:03:20 – EU compliance at a high level: directives vs standards; CE ≠ everything. We distinguish legal requirements (directives/regulations) from how-to methods (harmonised standards). CE marking signals conformity, but you also need safety, cybersecurity, labeling, and post-market processes to back it up.
00:06:51 – Who’s the “manufacturer” legally? Private label importers beware. If you put your name/brand on the product, you’re the manufacturer in the EU’s eyes, even if an ODM built it. That means you own the tech file, risk analysis, and corrective actions.
00:10:16 – Testing reports vs full compliance: technical file, risk assessment, manuals. A lab report ≠ compliance. Authorities expect a coherent technical file (scope, standards, test evidence), risk assessment, correct manuals/labels, and a Declaration of Conformity that ties it together.
00:12:26 – The “responsible person” & why it exists. An EU-based contact point who can liaise with authorities and hold documentation. We cover who can fill the role and how responsibilities differ between importers and ARs.
00:14:18 – Market Surveillance Reg (2019/1020) and GPSR expanding the scope. What MSR changed in enforcement, how GPSR broadens consumer product safety expectations (traceability, documentation), and what that means for non-EU brands.
00:17:41 – Importer obligations & the pain of sharing technical docs with many importers. Importers must verify compliance before placing goods on the market. We discuss practical ways to provide evidence securely and consistently without losing control of your IP.
00:20:03 – When to appoint an Authorized Representative (AR); DTC and online sellers. If you sell from outside the EU (including DTC/e-commerce), you may need an AR. We outline when it’s required, what they actually do, and typical service boundaries.
00:23:17 – Dropshipping into the EU: why customs may block you without an EU RP. Parcels can be stopped if there’s no EU-based economic operator on the label/documentation. We share real-world scenarios and how to avoid last-mile compliance failures.
…and much more. Listen to the episode for the full story!

Points that importers to the EU/UK should focus on

Map legislation & standards early. Identify which frameworks apply (CE directives/regulations, plus GPSR, RED, CRA, AI Act, where in scope). Document your conformity strategy.
Do a risk analysis and verification plan. Tie hazards to tests (electrical safety, EMC/RF, mechanical/chemical, cybersecurity). Keep evidence traceable to requirements.
Get roles straight, on paper. Define who is manufacturer/importer/distributor/EU AR is and their duties; align contracts and procedures.
Build the technical file as you go. Include use cases/claims, risk analysis, test reports, labeling/traceability, DoC, and a post-market plan.
Plan for software & security. For connected/digital products, address secure development, updates/patching, SBOM, vulnerability handling (CRA/RED timelines).
Operate change control. Any component, firmware, or supplier change that can affect safety/compliance triggers re-evaluation and, if needed, re-testing.
Be surveillance-ready. Keep EU contact points, retain documentation, and maintain a CAPA/recall playbook.

Common Mistakes

Treating CE as a single lab report rather than a system of duties and evidence
Late documentation; scrambling to assemble the technical file after production
Unclear economic operator roles (no EU AR; importer unaware of obligations)
Over-reliance on supplier certificates without verifying the scope and validity
No change control for firmware/components, resulting in “silent” non-conformities after updates
Ignoring cybersecurity/AI duties for connected or AI-enabled products (transition dates are real)

Importing into the EU: Product Compliance is More than Test Reports