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Medical devices

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Netherlands Enterprise Agency

Medical devicesExternal link are used in medical diagnoses and treatments, such as pacemakers or surgical instruments. If you manufacture medical devices in the Netherlands, you must registerExternal link your company and your class I devices with Farmatec. Certain rules apply when you use or manufacture these devices:

In vitro diagnostics

In vitro diagnostics (IVD) are a separate type of medical devices. They can be used to examine samples from the human body, such as blood or urine, outside the body. You need to register IVDsExternal link too with CIBG/Farmatec.

National Implants Registry

The Dutch National Implants RegistryExternal link registers the implants that patients in the Netherlands have received, such as artificial hip joints, artificial cardiac pacemakers or breast implants. The Registry has nationwide coverage and registration will become mandatory in 2019. Implant patient information leaflets will also become mandatory. In 2019 doctors will be obliged to record data on implants in the patient's Electronic Patient Dossier (EPD) and inform the patient. The National Implants Registry will collect this data from the hospital's EPD, making it easier to trace patients with implants.

This article is related to:

This information is provided by

Netherlands Enterprise Agency