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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 law with regard to medical devices
From 26 May the new Medical Devices Regulation will be in place. This means manufacturers, importers and distributors of medical devices will need to register in EUDAMED, the European Database on Medical Devices. 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. They have from 26 March 2020 until 26 May 2020 at the latest to register. This applies to all classes of medical devices. In-vitro diagnostics devices (IVDR) need to be registered from 26 May 2022.
Please note: EUDAMED will only be operational once the entire system and its different modules are fully functional, i.e. 26 May 2022. Until then you will need to register through Farmatec (in Dutch) for Class 1 medical devices and in-vitro diagnostics.
Software as a medical device
Software will be qualified more often as a medical device under the regulation. This means it will have to comply with the European Medical Devices Regulation. Any software that was already qualified as a medical device may fall into a higher risk category and therefore will have to comply with stricter rules.
If you are not sure if your product is a medical device, the European Medicine Agency (EMA) provides a detailed overview of what products are seen as a medical device.