Clinical research involving the use of medical devices
Any clinical research project or programme which involves the use of one or more medical devices is subject to a number of requirements. Some of the requirements are listed in the Medical Devices Decree and the Active Implants Decree.
Certain provisions of the Wet medisch wetenschappelijk onderzoek met mensen (Clinical Research involving Human Subjects Act) and the Wet op de geneeskundige behandelingsovereenkomst (Medical Treatment Agreements Act) also apply. Further information about the specific requirements and the obligation to notify the relevant authority of planned clinical research can be downloaded below (in Dutch only).
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