Gate one: CE marking
CE is self-declared conformity against the directives your product triggers — low-voltage, electromagnetic compatibility, radio equipment for anything wireless, machinery where it moves, plus the restricted-substances rules. The work is the technical file: standards applied, test reports, risk assessment, the declaration of conformity signed by the responsible party. Test houses handle the lab work; the file lives with you — and medical devices upgrade to their own regime entirely: that chapter.
Gate two: the border and the roles
EU product law names its actors: the manufacturer answers for conformity, the importer placing foreign goods on the market carries verification duties and its name on the box, distributors check downstream. Selling from outside the union also demands an EU authorised representative for market surveillance. A Dutch BV collects all these hats at one address — and handles the customs side with the classic cash-flow lever: the article-23 licence defers import VAT to the return instead of the border, the reason half of EU e-commerce logistics runs through here.
The startup’s sequence
Design against the directives from the first prototype, book the test house before the crowdfunding ships, set the BV as importer-of-record with article 23 in place, and let Rotterdam’s logistics do what it does: the build-side ecosystem and the structure above it.