The Medical Devices Decree (Besluit medische hulpmiddelen, in Dutch) defines the term ‘manufacturer’ as the person, legal entitiy, or the authorised representative of that person, who:
- is responsible for the design, manufacturing, packaging and labeling of a medical device with the aim of marketing said device under one’s own name, regardless of whether these actions are carried out by one and the same person or under the responsibility of a third party; or
- assembles, packages, processes, updates or labels one or more prefabricated products, or who assigns these products as a medical device with the aim of marketing said device under one’s own name.
If a specific medical device that is not (yet) on the market is developed at a health care institution in collaboration between doctors and technicians and within the framework of clinical research, then the institution or technical department in question is not a manufacturer in the sense of the Medical Device Decree. Therefore, no reporting procedure obligation exists towards the Health And Youth Care Inspectorate in accordance with the Decree. However, as soon as the clinical research with the developed medical device in question also extends to other institutions (doctor/researcher and development technicians are no longer within the same [institutional] structure of responsibility), the obligation to notify the Health And Youth Care Inspectorate does apply.