CE marking

CE marking is self-declared conformity against the directives that apply to your product: low-voltage, electromagnetic compatibility, radio equipment for anything wireless, machinery with mechanical parts, plus the restricted-substances rules. The core requirement is the technical file: standards applied, test reports, a risk assessment, and the declaration of conformity signed by the responsible party. Test houses handle the lab work, but you keep the file. Medical devices fall under their own, separate regime: that chapter.

For CE marking and the authorised representative, see which EU representative your product needs.

The border and the roles

Under EU product law, each party has a role. The manufacturer is responsible for conformity. The importer places foreign goods on the EU market, checks the manufacturer's work and puts its name on the box. Distributors check the products further down the chain. If you sell from outside the EU, you also need an EU authorised representative for market surveillance. A Dutch BV can take on all these roles at one address. The same BV can also be the importer for customs. With the article-23 licence, you declare the import VAT in your periodic VAT return, so you skip the payment at the border. This is one reason why half of EU e-commerce logistics is handled through the Netherlands.

You can import into the EU through the Netherlands and pay zero VAT at the border. See fiscal representation for non-EU importers. There you read about the Article 23 licence, the EORI number and the monthly work involved.

The order of steps for a startup

Design the product to meet the directives from the first prototype. Book the test lab before you ship to your crowdfunding backers. Set up the BV as the importer of record, with an article 23 licence. Logistics companies in Rotterdam can then handle storage and delivery. See the hardware cluster in Eindhoven and the holding structure above the BV.

For the importer duties behind the CE mark, see machinery and electronics in Europe. That page also covers Regulation (EU) 2023/1230 on machinery, which applies from 20 January 2027, and the Cyber Resilience Act.