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Government information for entrepreneurs

Manufacturers and importers of medical devices must register in EUDAMED

This information is provided by

Netherlands Enterprise Agency, RVO

Effective date: 26 May 2021

What changes?

Are you a manufacturer, authorized representative (distributor) or importer of medical devices? You must register data on yourself, your company and your medical device in EUDAMED. EUDAMED is the European Databank on Medical Devices. Information in medical devices and manufacturers is included in EUDAMED.

After registration you will get a Single Registration Number (SRN). You need to register before you market a new device. Manufacturers need to register to be able to apply for an assessment of their medical device with a notified body. This applies to all classes of medical devices.

For whom?

  • manufacturers, authorized representatives (distributors) and importers of medical devices

When?

Registering in EUDAMED

Manufacturers, distributors and importers that already market medical devices can register in EUDAMED from March 2012

Registering products

From May 2021 manufacturers have 18 months to register their medical devices in EUDAMED.

This information is provided by

Netherlands Enterprise Agency, RVO