What it covers
Placing a product on the EU market means completing a defined sequence: scope, standards, evidence, documentation, declaration, marking, and the obligations that continue after launch.
- Identify every applicable directive and regulation for your product's intended use
- Select harmonised standards to gain presumption of conformity
- Test and gather evidence, including design rationale where standards are not applied in full
- Compile the technical file, sign the Declaration of Conformity, affix the CE mark
- Keep the file for ten years after the last unit is placed on the market
Does it apply to you?
It applies to whoever places the product on the EU market under their own name or trademark, that is the manufacturer's role in law, regardless of who built it.
- Rebranding an ODM product makes you the manufacturer with every obligation that carries
- Importers and distributors have their own verification duties
- Manufacturers outside the EU need an authorised representative and, under the Market Surveillance Regulation, a responsible person established in the EU
What testing looks like
For a typical connected electronic product, the campaign is radio, then EMC, then safety, with documentation running alongside rather than afterwards.
- Radio under RED with the relevant EN 300 series standard, if the product transmits
- EMC emissions and immunity at the levels for the intended environment
- Electrical safety to EN 62368-1, or the relevant product-family standard
- RoHS material declarations and REACH SVHC screening from suppliers
- Where applicable: WEEE registration, packaging, battery regulation and ecodesign obligations
Common failures
- A Declaration of Conformity listing directives that no longer exist or standards that have been superseded
- Technical file built from lab reports alone, with no design rationale connecting them to the essential requirements
- Product changed after testing, with no impact analysis recorded
- No EU responsible person, blocking customs on the first shipment
- Labels and instructions missing required languages for the destination markets
Next step
Start with the Compliance Route Finder to see which directives and standards apply to your exact configuration, then book an assessment call to turn it into a sequenced plan with cost and timeline.
Work it out for your product
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