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Registration procedure for in-vitro diagnostic medical devices

If you wish to market an in-vitro diagnostic device (IVD) in the Netherlands, you must first register the product with the CIBG. You are also required to register yourself as the manufacturer.

This requirement also applies to the authorized European representative in the Netherlands of a manufacturer which is not based in the EU. According to the Directive on Medical Devices for In-vitro Diagnostics (98/79/EC), a manufacturer wishing to market an in-vitro diagnostic device must register with the authorities in the member state in which it is based, i.e. has registered offices.

The Directive envisages a database of all such registrations, accessible to all member states. Until this database is created, a provisional arrangement is in force whereby manufacturers (or their representative) must register themselves and their products in every member state in which those products are to be marketed. Registrations are to be submitted to:


CIBG
Farmatec-BMC
P. O. Box 16114
2500 BC The Hague, The Netherlands
E-mail: medische_hulpmiddelen@minvws.nl

Further information and the required forms can be found at Farmatec.nl.

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