The gate: CE under the MDR
Every device classifies by risk (I through III), and everything above the lowest class runs through a notified body — the audit of your technical file and quality system that produces the certificate behind the CE mark. Notified-body capacity is the industry’s famous bottleneck: slots are booked quarters ahead, which makes the certification calendar the real launch calendar.
The roles your Dutch entity plays
Manufacturers outside the EU appoint an authorised representative — the EU-resident legal face toward regulators — and sales into the union run through an importer with its own verification duties. A Dutch BV can hold both roles plus the commercial contract with every hospital and distributor: one entity, three hats, and procurement teams that onboard it on sight: the wider CE-and-import chapter.
The stack around the device
Software-as-medical-device teams stack the WBSO on development (the credit) and the innovation box on the result (the 9%); privacy-heavy products add the health-data chapter: that page. The corporate chart is the standard skeleton with the certificate-holding entity chosen deliberately: the structure.