Clinical trials of medicinal products involving medical devices can be categorized into three cases. In each of these cases, different legislation and regulations apply to ensure the safety and efficacy of the product. The three cases are: a combination of a medical device and a medicinal product, a medicinal product using a medical device, and two separate products, one being a medicinal product and the other being a medical device.
Medicinal product clinical trials involving medical devices might be summarized in the following three cases.