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Technical File 2026: CE • DoC • Test Reports • Risk Analysis • Labeling — fix-it-later fails

Technical File Checklist Before Shipping Products to Europe
A Practical List

If you ship to the EU, one rule decides everything: your Technical File must be audit-ready. CE marking alone is not proof. The proof is your documentation: classification → evidence/tests → technical file → labeling → registrations → marketplace readiness.

Build your Technical File with Grexon Technical file checklist
Start correctly: define the product. A wrong scope kills the entire file.

1️⃣ Product identity & scope

Define what the product is — and which rules apply

Your file starts with classification. If you can’t clearly explain what the product is and how it’s used, every “compliance document” becomes guesswork.

  • Product name, model, SKU/variant list
  • Intended use, user group, environment (home/industrial, indoor/outdoor)
  • Target EU countries and sales channels (Amazon, wholesale, etc.)
  • Applicable EU directives/standards determined (product-dependent)
Reality: wrong scope = wrong tests = wasted money.
Your file must show how the product is built — not just how it looks.

2️⃣ Technical design & construction evidence

Drawings, BOM, materials — the backbone

Audits don’t accept vague descriptions. You need controlled technical information that matches your production reality.

  • Technical drawings (dimensions, key parts)
  • BOM / component list (critical parts clearly identified)
  • Material list for plastics/metals/coatings/chemicals
  • Electronics: circuit/block diagrams where relevant
Clear: no structure info = weak Technical File.
Risk assessment is the part that decides if your CE claim is defendable.

3️⃣ Risk assessment (mandatory)

Identify hazards and prove mitigations

A Technical File without risk assessment is incomplete. You must show hazards, severity, probability, and the measures you took in design, labeling, and instructions.

  • Mechanical, electrical, thermal, chemical hazards
  • Foreseeable misuse scenarios (real-world behavior)
  • Risk controls: design changes, protections, warnings
  • Traceable link to tests and instructions
Hard truth: no risk assessment = no serious compliance.
Tests are not optional — they are the evidence behind your declaration.

4️⃣ Test reports & standards evidence

Proof beats promises

You must keep test evidence that matches your exact model/variant and references the correct standards. Marketplace compliance cases typically start here.

  • Test reports (CE-relevant: EMC/LVD/RED, product-dependent)
  • Material/substance evidence (RoHS, where applicable)
  • Standards list with version/date references
  • Clear mapping: product variant ↔ report ↔ standards
Clear: no tests, no defendable DoC.
Declarations and registrations: this is where legal responsibility becomes visible.

5️⃣ Declarations & registrations (DoC, REACH/RoHS, WEEE)

Statements must be backed by evidence

Declarations are legal commitments. They must match your test evidence, materials list, and labeling. If you sell EEE, WEEE obligations must be addressed too.

  • Declaration of Conformity (DoC): product, directives, signer, date
  • REACH/SVHC supplier statements + tracking logic
  • RoHS declarations (for EEE scope, where applicable)
  • WEEE: scope check + registration readiness (country-dependent)
Plain: declarations without evidence are liabilities.
Consistency check: product label, packaging, manual, and listing must match.

6️⃣ Labeling, manual & marketplace consistency

Most failures are simple inconsistencies

Auditors and marketplaces flag contradictions. Your label, packaging, manual, and online listing must reflect the same technical truth.

  • Mandatory label fields verified (manufacturer/importer, model, warnings)
  • Correct CE/WEEE marks applied where required
  • User manual localized for the target EU market (language + safety)
  • Amazon listing text/images aligned with your documentation
Hard truth: inconsistency is the fastest way to get restricted.
Checklist: if you answer “no”, you’re not ready to ship/sell.

7️⃣ Quick Technical File checklist (before shipping)

“No” answers create risk — guaranteed

  • Product identity, variants, and scope defined?
  • Directives/standards list confirmed for the EU?
  • Drawings, BOM, and materials list available and current?
  • Risk assessment completed and linked to mitigations?
  • Test reports collected and mapped to exact variants?
  • DoC prepared with version control and sign-off?
  • REACH/SVHC & RoHS evidence collected from suppliers?
  • If EEE: WEEE scope checked and registration plan ready?
  • Label/packaging/manual/listing fully consistent?
  • Can you deliver the file within 24–48 hours if asked?
Plain truth: if you can’t provide it fast, you don’t control it.

🔗 Conclusion

A Technical File is not a formality. It’s your legal and commercial shield in the EU. If you build it properly, growth becomes stable. If you ignore it, every sales push creates bigger risk.

Plain: No Technical File, no sustainable EU sales.
Disclaimer: This article is for informational purposes only and does not constitute legal advice.

Ship to Europe with an audit-ready Technical File

If you want to set up your Technical File, evidence, labeling, and marketplace compliance end-to-end — and avoid last-minute failures — work with Grexon.