Registration of a medical device or IVD
Manufacturers may place a medical device or in vitro diagnostic device (IVD) in Europe only if it complies with the statutory requirements. The Health and Youth Care Inspectorate (IGJ) is responsible for monitoring, and supervising compliance alongside oversight counterparts from the other European Member States. Dutch manufacturers or authorised representatives of non-EU manufacturers established in the Netherlands are obliged to register (notify) certain risk classes of medical devices and IVDs nationally.
National registration of a medical device is a statutory obligation (Dutch Medical Devices Act, Section 24/25) and helps the Inspectorate carry out its supervisory remit in respect of these devices.
Registration of medical devices and in vitro diagnostic devices
This concerns the registration (notification) of Dutch manufacturers or authorised representatives of non-EU manufacturers established in the Netherlands introducing a class I medical devices and or IVDs that are being placed on the European market. More information about the registration of economic operators and medical devices is available on the Farmatec website.
Registration of clinical trials investigations or performance studies
To register clinical investigations with medical devices or performance studies with IVDs, please contact the Central Committee on Research Involving Human Subjects (CCMO).
To report any incidents (MIR) with or field safety corrective actions (FSCA) regarding medical devices and IVDs, please contact the Health and Youth Care Inspectorate. Please find more information on this page on our website.
Mandatory registration for manufacturers and authorised representatives
There is a registration obligation (notification obligation) for manufacturers or their authorised representatives established within the Netherlands that are placing a medical device, system or procedure pack on the market in the following class:
- Class I medical device
- Custom-made medical device
- In vitro diagnostic device (IVD) (all risk classes)
What does the Inspectorate do?
The Inspectorate monitors and verifies whether manufacturers of medical devices and IVDs are in compliance with the rules and regulations and takes actions in the event of any violations. The registration obligation as outlined above is one of the statutory requirements.