What is CE marking? The EU self-declaration that lets you place a product on the market
CE marking is the manufacturer's declaration that a product meets every applicable EU product directive — Toy Safety, LVD, EMC, RED, PPE or Machinery, in most ecommerce cases. It is self-declared (Module A) for non-Annex-IV products, but you must hold a technical file and a signed EU Declaration of Conformity (EN ISO/IEC 17050-1) for ten years. Amazon EU has intensified DoC requests since August 2025 and delists ASINs that cannot produce one.
Direct answer
CE marking is the manufacturer's declaration that a product complies with every EU product directive that applies to it. For most ecommerce categories — toys, mains-powered electronics, radio equipment, PPE Cat. I, non-Annex-IV machinery — the manufacturer self-declares under conformity assessment Module A: no notified body is involved. You must still hold:
- a technical file (drawings, risk assessment, test reports, applicable harmonised standards) — retained 10 years
- a EU Declaration of Conformity (EN ISO/IEC 17050-1 format, signed) — retained 10 years
- the CE mark affixed visibly, legibly and indelibly to the product (or its packaging / accompanying documents where the product is too small)
The six directives most ecommerce sellers touch
| Directive | Covers | Citation |
|---|---|---|
| Toy Safety | Anything designed/intended for play by children under 14 | 2009/48/EC |
| LVD | Mains-powered electrical equipment 50–1000 V AC / 75–1500 V DC | 2014/35/EU |
| EMC | Anything that emits or is susceptible to electromagnetic disturbance | 2014/30/EU |
| RED | Anything with a radio transmitter (Bluetooth, Wi-Fi, RFID, Zigbee, Z-Wave) | 2014/53/EU |
| PPE Cat. I | Minimal-risk personal protective equipment (gardening gloves, sunglasses) | (EU) 2016/425 |
| Machinery (non-Annex IV) | Most consumer machinery — moving parts, motors, pumps | 2006/42/EC → (EU) 2023/1230 from 20 Jan 2027 |
Multiple directives stack — a Bluetooth speaker is LVD + EMC + RED + RoHS.
What the EU Declaration of Conformity must contain
Under EN ISO/IEC 17050-1, every DoC must name:
- The product (model, type, batch or serial)
- The manufacturer (and EU authorised representative where required)
- A statement that the DoC is issued under the sole responsibility of the manufacturer
- The object of the declaration (sufficient to identify the product)
- Each EU directive the product conforms to, with its full citation
- Each harmonised standard or technical specification used
- Notified body details where a directive requires one (not Module A)
- Place, date, name, function and signature
Missing fields = invalid DoC, regardless of whether the product is safe.
Amazon EU and the delisting risk
Since August 2025, Amazon EU has automated DoC and technical-file requests on covered ASINs. The failure mode is the same across categories: seller cannot produce a compliant DoC inside the SLA → ASIN delisted → reinstatement requires a fresh DoC that survives template review.
What Regonance does on CE
- Routes each product to the directives that actually apply (TSD / LVD / EMC / RED / PPE / Machinery), based on category and characteristics
- Returns a per-directive readiness assessment with typed findings (missing harmonised standard reference, unsigned DoC, address mismatch)
- Generates a real EN ISO/IEC 17050-1 PDF Declaration of Conformity — not a placeholder
- Versions the DoC append-only so authorities can see the document history
- Flags out-of-scope (Annex-IV machinery, notified-body categories) and points to specialist conformity-assessment bodies instead of pretending to cover them
Frequently asked questions
Does the CE mark mean a regulator approved my product?+
No. CE is a manufacturer self-declaration under conformity assessment Module A for most ecommerce categories — no regulator review, no certificate, no approval. The mark says you have a technical file and DoC and accept liability for the claim. Authorities can test the product post-market and prosecute if the declaration is false.
How long do I have to keep the technical file and DoC?+
Ten years from the last unit placed on the EU market. Applies to every covered directive.
Can I CE-mark non-Annex-IV machinery myself?+
Yes — Directive 2006/42/EC (and (EU) 2023/1230 from 20 January 2027) lets you self-declare conformity for machinery outside Annex IV. Annex-IV products (saw benches, presses, lifts, etc.) require a notified body and Regonance flags them as out of scope.
What changes on 20 January 2027?+
The Machinery Regulation (EU) 2023/1230 fully replaces the Machinery Directive 2006/42/EC. Technical files written today need an update path — digital instructions become acceptable, the safety component list is broader, and high-risk Annex-I products move into stricter assessment.
Why is Amazon EU asking for the DoC right now?+
Since August 2025 Seller Central runs automated DoC and technical-file requests on CE-covered ASINs. The pattern is consistent: 14-day SLA, template review on the response, delisting if it fails. We're seeing it most on toys, electronics with Bluetooth, and PPE Cat. I.
Does CE marking cover RoHS, REACH or WEEE?+
No. CE attests conformity with product-safety directives; RoHS, REACH/SVHC and WEEE are separate regimes with their own evidence trails. Regonance covers REACH/SVHC on Pro and Agency and surfaces WEEE EPR registration in the EPR module.
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