Tech & Digital

Medtech Entering Europe: Certification and Your Dutch Entity

Updated: 18 August 2026 Holdwise editorial team Medtech MDR CE

To sell a medical device in Europe, you need CE marking under the medical-device regulation (MDR). Certain legal roles must also be filled inside the EU. For international medtech companies, a Dutch company often takes on all of these roles. At Holdwise, we keep this answer up to date and change it when the rules change.

CE marking under the MDR

Every device is classified by risk (class I to III). Everything above the lowest class needs a notified body. The notified body audits your technical file and quality system and issues the certificate behind the CE mark. Notified body capacity is the well-known bottleneck in the industry. Slots are booked quarters ahead, so your launch date often depends on the certification schedule.

Food, cosmetics, medical devices or chemicals? See which EU representative your product needs, by sector.

The roles for your Dutch entity

Manufacturers outside the EU appoint an authorised representative, the legal contact in the EU for regulators. For sales in the EU, you also need an importer, which has its own verification duties. A Dutch BV can take on both roles, and it can also sign the commercial contracts with hospitals and distributors. You then have one company for three roles, and procurement teams know this setup well. See the chapter on CE marking and import.

Compare the Netherlands with Ireland and Germany on tax, substance, running costs and time. See setting up a Dutch subsidiary for a foreign parent company.

Tax and IP around the device

Teams that make software as a medical device often combine two schemes. They use the WBSO for development (see the WBSO wage credit). They use the innovation box for the result (see the 9% innovation box). If you process a lot of health data, also read the health-data chapter. The company structure is the standard one. Choose with care which company is the holder of the certificate. See the startup holding structure.

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Part of Doing Business in the Netherlands, the complete 2026 guide.

Frequently asked questions

Can our Dutch BV be the legal manufacturer instead? +

Yes. If you place the device on the market under the BV's name, the BV is the manufacturer and has the full MDR duties. The product is then regulated from inside the EU. It is worth a short design session.

How long does MDR certification realistically take? +

It depends on the class and on the capacity of the notified bodies. It takes several months for lower classes and well over a year when the clinical evaluation is extensive. Book the notified body as early as you can.

When was this last checked? +

Reviewed 18 August 2026. The MDR framework is current, and the capacity of notified bodies is slowly improving.

Sources Belastingdienst · KVK · wetten.overheid.nl Last updated: 18 August 2026