CE RED Documentation Importers Need: A Buyer Checklist
When a customs officer, a marketplace compliance team or a national market surveillance authority asks about a wireless wearable, they ask the importer, not the factory. That is the structural point many first-time buyers miss: under EU rules the importer carries the obligation to hold the technical documentation and to place a compliant product on the market. The supplier's job is to hand you a complete, revision-specific pack that stands up to that scrutiny. This article sets out what that pack contains, using the standard names you will see on the documents themselves, and where an importer should decline to proceed.
The core CE RED pack, document by document
Radio Equipment Directive 2014/53/EU is the legal instrument. The evidence underneath it is a set of test reports produced against harmonised standards, and for a typical AI wearable the radio scope is tested to EN 300 328 for wideband 2.4 GHz operation, with EN 301 489 covering electromagnetic compatibility. Electrical safety sits under EN 62368-1. These three names should appear on the reports you receive, with the accredited laboratory identified, the model and hardware revision stated, and the test dates inside a reasonable window. A document that lists a different model number, or omits the revision, is not evidence for your product. Our own CE RED document checklist mirrors this structure and is worth comparing line by line against whatever a candidate supplier sends you.
Alongside the reports you need the declaration of conformity. This is the manufacturer's signed statement that the product meets the directive, naming the standards applied, the manufacturer's identity and address, and the authorised representative where applicable. It is a one or two page document and it is the single most requested item in an importer's file. If a supplier offers only a certificate from a test house and no declaration, the file is incomplete.
Documents beyond the radio scope
Wireless approval is not the whole file. RoHS 3 and REACH SVHC screening statements cover restricted substances, and for any item worn against the skin, EN 1811 nickel release testing is relevant. Batteries travelling by air need UN38.3 test summaries and a safety data sheet. Where the product includes a camera or an AI companion function, buyers frequently ask about the age grading printed on the packaging, because that grading determines whether a toy scope applies. Toy standards EN 71-1/-2/-3 and EN 62115 are booked with an accredited laboratory per build when the grading requires it; they are not a default part of a wearable file. Service robots sit in a different lane again, with an EMC and low-voltage scope, a class 1 laser statement for the LiDAR, and a documented risk assessment.
| Document | What it covers | Importer action |
|---|---|---|
| Radio test report | EN 300 328, transmitter behaviour | Check model and hardware revision match the shipment |
| EMC test report | EN 301 489 | Confirm the laboratory is accredited for the scope |
| Safety report | EN 62368-1 | Verify it covers the charger and the battery pack |
| Declaration of conformity | Directive 2014/53/EU, standards applied | Keep the signed original in the technical file |
| Battery documents | UN38.3 summary and SDS | Needed for air freight booking |
| Substance statements | RoHS 3, REACH SVHC, EN 1811 where skin contact applies | Match the statement to the materials actually used |
| UKCA pack | Separate UK marking route | Request on order if you sell into Great Britain |
What is not in the supplier's file
Several obligations sit with you and cannot be delegated. WEEE registration, the German BattG battery take-back regime, the French DEEE and Triman marking requirements, and your EORI and VAT position are importer duties. A supplier can give you the material and battery data you need to complete those registrations, but cannot register on your behalf. The same applies to marketplace listings: the compliance team will ask you for the declaration and the reports, and they will ask for them per model. Buyers who have not read how to vet a supplier often discover this only after the first purchase order.
Where to say no
A short list of refusals saves months. Decline a supplier who sends a certificate with no test report behind it. Decline documents that name a different model or omit the hardware revision. Decline a file where the declaration of conformity has no signature, no address or no standards listed. Decline any claim that a single certificate covers future revisions, and decline verbal assurances that a certificate "is coming" after the deposit. If the supplier cannot produce the pack before tooling starts, the risk transfers to you, not to them.
- Ask for the pack per model and per hardware revision, in PDF, before the deposit.
- Check that the accredited laboratory is named and the test scope is stated.
- Confirm whether UKCA is needed for your sales territory and request it on the order.
- Keep the declaration of conformity and the technical file for ten years after the last unit is placed on the market.
- Request UN38.3 and the SDS early if you plan air freight.
- Confirm the age grading on the packaging before assuming a toy scope does or does not apply.
The practical next step is to send your specification and target markets to the factory and ask for the document pack that matches the exact build you intend to buy. You can see how we structure testing and quality gates on our factory page, review OEM/ODM services if the project needs custom tooling, and check MOQ, sampling and lead times so the compliance timeline sits alongside the production plan rather than after it. When you are ready, send us the specification and we will tell you which documents apply to your model, which are booked per revision, and which obligations remain with you as the importer.
Questions buyers ask
What documents should a CE RED importer receive for an AI wearable?
At minimum a radio test report, an EMC report, a safety report, a declaration of conformity and a technical file. The importer should also hold the battery UN38.3 summary and SDS, plus RoHS and REACH statements. All documents must match the model and hardware revision shipped.
Does a supplier's CE certificate cover every production batch?
No. CE is a self-declaration supported by testing, so the declaration binds the manufacturer to a specific build. If the radio module, antenna or enclosure changes, the test evidence may no longer apply. Ask for documents tied to the revision you are buying, not a generic certificate.
Related: more on sourcing & compliance · buyer guides · customisation tiers