Research with medical devices in combination with a medicinal product

Products that physically combine a medicinal product or medical substance with a medical device fall either within the scope of the MDR or the EU Clinical Trial Regulation (CTR). The intended function of the medical device determines whether the MDR or CTR applies.

Is the effect of the medicinal product the most important? Then the combined product is considered to be a medicinal product and clinical investigation with the product falls within the scope of the CTR. In such a situation, the medical device must also meet the relevant safety and performance requirements of the MDR. Is the medical device not physically combined with a medicinal product? Then the medical device falls within the scope of the MDR.