Medical device with a medicinal product
The question of whether a clinical investigation 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. A medical device that also contains a medicinal product is a medical device if the action of the medicinal product is ancillary to the action of the medical device. Examples are a drug-eluting stent, a bone cement with an antibiotic and a urinary catheter with a local anesthetic. To these products the legislation for clinical investigations with medical devices applies.