It is well known that the Medical Devices 93/42/EEC and the IVD 98/79/EEC Directives are leaving space to National Competent Authorities regarding the application of the laws, and also the eventual imposition of additional requirements when possible. One of the typical examples is usually represented by the provision of Official taxes to be paid prior to or post submission of official documents related to specific procedures (e.g. Registrations, Notifications, Free Sales Certificates).
In Belgium, the MDD and the IVDD were respectively transposed (and actuated) in the Arrêté royal relatif aux dispositifs médicaux du 18 MARS 1999 and the Arrêté royal relatif aux dispositifs médicaux de diagnostic in vitro du 14 NOVEMBRE 2001.
In both cases a provision of a tax (from 158,58 to 1540,34 euros depending on the cases/classes of devices) was included for the Notification of:
A) Class I medical devices (including Im and Is)
B) System/ Procedure packs/ Kits
C) Custom Made Devices
D) All classes of IVD devices
Those provisions were representing a doubled cost for manufacturers in terms of money, but also time as this was an essential requirement to be met before File Submission to CA.
Thanks to two recent Royal Decrees modifying the previous laws, all the above mentioned taxes were abolished on 5 April 2018, together with the tax for IVD Free Sales Certificates. This is good news for all manufacturers represented by Obelis, but also for any new manufacturer wishing to enter the European market. The abolishment of the taxes makes is even more convenient to enter the EU market from Belgium, and of course through Obelis as your European Authorized Representative (EAR).
If you would like to receive more information on Registrations, Notifications, Free Sales Certificates, or on Medical Devices and IVDs in general, please do not hesitate to contact us. We will gladly assist you and help you to enter the European market in the quickest and most convenient possible way!