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Medical devices

This information is provided by 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 will have nationwide coverage and registration will become mandatory. Implant patient information leaflets are going to be mandatory as well.

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Netherlands Enterprise Agency