Most companies ask this question after someone else asks them for a document. A European customer sends an email asking for a CE declaration. An Amazon EU listing check requests test reports. A freight forwarder wants the battery report before the shipment leaves. By then the product is usually already designed, and often already in production.
The good news is that the answer follows four questions, not a list of thirty certifications. What is the product, does it transmit radio, how is it powered, and who is placing it on the EU market. Everything else follows from those four answers.
The four questions that decide your certification scope
- What is the product? A charger, a toy and a lighting fixture are regulated by different directives, even though all three carry CE marking.
- Does it transmit or receive radio? Bluetooth, Wi-Fi, 2.4 GHz proprietary protocols, 4G, RFID. If yes, radio equipment rules apply on top of everything else.
- How is it powered? Mains voltage brings safety requirements that battery-powered devices do not have. A lithium battery brings transport requirements that a mains device does not have.
- Who is responsible in the EU? Your own EU entity, your importer, or in practice, nobody yet. This one is asked more often than it used to be.
What normally applies, by product type
| Product | Normally applies |
|---|---|
| Mains-powered device (charger, adapter, appliance, LED driver) | EMC + safety (LVD) + RoHS |
| Battery or USB-powered device, no radio | EMC + RoHS |
| Bluetooth, Wi-Fi or other wireless device | Radio Equipment Directive (covers safety, EMC and spectrum) + RoHS, plus a radio frequency exposure assessment where relevant |
| Device with a lithium battery | The above, plus UN38.3 transport testing for shipping |
| Toys and products aimed at children | Toy safety requirements and EN 71 test series, plus the above where applicable |
| Product sold on Amazon EU | The above, plus the documentation Amazon requests during listing and compliance checks |
This is a starting point, not a substitute for a scope review. Exclusions exist. Some products fall outside the Low Voltage Directive range, some fall outside RoHS scope, and some categories carry additional sector rules.
CE marking is a claim, not a certificate
This is where most confusion starts, and it is worth being precise because it changes what you should ask a laboratory for.
CE marking is applied by the manufacturer - or by the EU importer, if the manufacturer is outside the EU - after the product has been assessed against the applicable directives. There is no single authority that issues "a CE certificate" for a normal electronic product. What you produce is:
- Test report(s) from an accredited laboratory, showing the product was tested against the relevant standards
- Technical file with design documentation, BOM, manuals, risk assessment and reports
- Declaration of Conformity, signed by the responsible company, listing the directives and standards applied
- CE marking on the product or its packaging, plus the responsible company details
For some radio products, where harmonised standards are not fully applied, a Notified Body has to be involved. Most consumer wireless products do not need this, but the exception is real and affects scope and timeline when it applies.
The entity named on the Declaration of Conformity is the entity that takes legal responsibility. This is the detail that quietly decides whether your supplier's existing CE documents can be used for your product - and many times, they cannot, because the declaration names the factory, not you.
EMC, LVD and RED are the technical part of CE
- EMC covers electromagnetic emissions and immunity. It applies to almost every electronic device, powered by mains or battery.
- Safety requirements apply to equipment operating within the mains voltage range covered by the Low Voltage Directive. A USB-powered device can fall outside it while a 12 V mains adapter in the same box does not.
- Radio Equipment Directive (2014/53/EU, applicable since June 2016) covers radio products and includes safety and EMC for those products, plus spectrum use and, for transmitters, exposure considerations.
A quick practical note. When a product has both a radio and a mains adapter, the scope usually contains tests under more than one directive, and the reports are read together. If you only tested the radio, your file will have a gap the buyer's compliance team can find.
RoHS and REACH are separate questions from CE
RoHS restricts substances in electrical and electronic equipment - ten substances under the current Directive (2011/65/EU as amended). Testing covers material groups: solder, plastics, coatings, and so on. A RoHS report answers "are restricted substances below the limits in the tested materials".
REACH is chemicals legislation and asks a different question. For most electronics, the relevant points are Substances of Very High Concern above 0.1% by weight in an article, and the SCIP notification duty for articles containing them. The candidate list changes twice a year, which is why an old REACH statement is not automatically valid today.
A RoHS report does not cover REACH. Companies regularly send a RoHS report to a buyer who asked for REACH, and lose a week in the process.
GPSR and the EU responsible person
The General Product Safety Regulation (EU) 2023/988 applies from 13 December 2024, replacing the older GPSD. What it changed in practice for suppliers outside the EU is this: products sold into the EU need a responsible person established in the EU, and online listings have to carry certain product and responsible person information.
This is why European buyers and marketplaces started asking Chinese suppliers for a responsible person rather than only a test report. If nobody in your chain can be that entity, it becomes a commercial problem, not just a paperwork problem.
What Amazon EU asks for in a compliance check
Requests vary by category, but the usual asks are the Declaration of Conformity, test reports that match the model being listed, label and product photos, and responsible person details. Some categories also require registration numbers for waste obligations in specific countries, or battery and packaging compliance references.
One rejection reason we see repeatedly, and it is entirely avoidable: the model number in the test report does not match the model number on the listing. The product is compliant, but the documents do not connect to the listing.
If the product contains a lithium battery
Certification for the market and permission to ship the battery are two different things:
- UN38.3 test report, plus the related transport documents, for shipping lithium batteries - air, sea and courier carriers all ask for it
- IEC 62133-2 cell and battery safety testing, frequently requested by buyers and marketplaces even where it is not the transport requirement
- EU battery regulation obligations, which are being phased in over several years and cover areas such as labelling, carbon footprint information and due diligence depending on battery type and timing
If the battery is inside the product, the device still needs its own EMC and, where relevant, radio and safety testing. The battery report does not cover the device, and the device report does not cover the battery.
Documents that actually change hands
By the end of a European compliance project, these are the files a buyer or marketplace usually receives: test reports, the Declaration of Conformity, label artwork showing the CE mark and responsible company, a responsible person declaration, and for battery products the UN38.3 report plus MSDS. The technical file stays with the responsible company but must be available if a market surveillance authority asks for it.
Where real projects tend to go wrong
- Manual version mismatch. The manual sent with the samples was not the final shipped version, so the report references an accessory or a specification that no longer matches production.
- BOM and sample are not the same product. The adapter, battery or display module was changed after the samples were prepared. Testing is done on what arrives, not on what was intended.
- Only one radio mode was declared. The device supports Bluetooth and a second 2.4 GHz mode, but only Bluetooth appears in the technical description. The additional mode has to be tested, and the file is incomplete until it is.
- Component reports are used as product reports. A compliant module does not make the finished device compliant. Final product testing is what the buyer and the authority read.
- The label has no EU entity. The CE mark is there, but there is no EU importer or responsible person address, which is exactly what the regulation and the marketplace look for.
- The power adapter was changed after testing. Adapters are part of the tested configuration for EMC. A different adapter can change results and may require retesting.
How to work out your scope before you pay for testing
Before samples ship, gather these and hand them to the laboratory in one go:
- Product photos, spec sheet and full model list (including variants you intend to sell)
- Radio modes and frequencies, antenna type and gain, transmit power
- Power supply details: adapter model, input and output ratings, battery type and capacity
- Target countries, and whether the UK is also in scope - UKCA is a separate route from CE
- Sales channel, so the documentation can be prepared in the form a marketplace asks for
- Whether an EU importer or responsible person is already identified
Reviewing the scope before samples are shipped is almost always cheaper than discovering a missing test after the report is issued. It also means the quotation you compare from different laboratories is based on the same configuration - which is usually the reason the numbers looked different in the first place.
Not sure which of these apply to your product?
Send us your product specification, model list, radio and power details, and the countries you plan to sell in. We can review the likely testing scope before you send samples, and tell you which documents your European customer or marketplace is most likely to request.