MDStudy object
MD - Definition available in national law
Yes
Additional Information
Combination studies:
The question of whether a research with a medical device or active implant falls under the scope of the regulations for research with a medicinal product as laid down in the WMO, is important when the medical device (or active implant) also contains a medicinal product.
The CCMO (Central Committee on Research Involving Human Subjects) does not consider medical devices combined with medicinal products as a medicinal product as long as the effect of the medicinal product has a subordinate function with regards to the function of the medical device. A drug eluting stent is an example of this. The legislation for research with medicinal products is not applicable in this case.
