Logo of the Dutch governmentGo to homepage

Government information for entrepreneurs

Medical devices

This information is provided by

Netherlands Enterprise Agency, RVO

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 (in Dutch) 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 has become mandatory. Patient information leaflets on implants are also mandatory. As of 2019 doctors are 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. Patients can use this information to report any side-effects of implantsExternal link (in Dutch).

Upcoming changes in EU law with regard to medical devices

If you work with medical devices in the health sector or are a manufacturer, importer or distributor, find out about upcoming changes in European Union law.

This information is provided by

Netherlands Enterprise Agency, RVO