When the IGZ has all requested information and there are no additional questions, the IGZ will sent a formal (written) acknowledgement that the obligation of notification under the decree has been fulfilled. The manufacturer is requested to sent a copy of this letter of confirmation to the principal investigator and to inform the IGZ when foreign healthcare inspectorates, like the Food and Drug Administration (FDA), want to inspect files of Dutch patients participating in the investigation.
Related information is available on IGZ website in section: Home>English>Medical devices>Clinical research involving the use of medical devices
