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Medical devices are used in medical diagnoses and treatments, such as pacemakers or surgical instruments. If you manufacture medical devices in the Netherlands, you must register your company and your class I devices with Farmatec. Certain rules apply when you use or manufacture these devices:
- CE marking
- risk categories
- custom-made devices
- labelling and instructions for use
- clinical research
- licences and discharges
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 IVDs too with CIBG/Farmatec.
National Implants Registry
The Dutch National Implants Registry (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 implants (in Dutch).
Upcoming changes in EU law with regard to medical devices