Reporting to the Health and Youth Care Inspectorate
The Dutch Health and Youth Care Inspectorate is the competent authority for notifying clinical research with a medical device that involves a manufacturer who is responsible for the development of the medical device. Such research must be notified to the Health Inspectorate by the concerned manufacturer. This applies to both medical devices without a CE marking as to those with a CE marking* which use differs from the intended use as defined in the respective conformity review procedure (new indication). The notification procedure is given on the website of the Health And Youth Care Inspectorate.
* A CE marking is often incorrectly seen as a (quality) hallmark. However, a CE certification implies a declaration of conformity of the medical device in question with the essential requirements such as those set forth in the Medical Device Dossier (MDD). Depending on the risk class, the CE marking is issued by the manufacturer himself or by a Notified Body. The CE marking applies to the ‘intended use’ of the medical device as defined by the manufacturer.