Radio-embolization with Holmium-166 spheres and brachytherapy (using for example iridium-192, iodine-125 or caesium-131) are considered medical devices, whereas Lutetium-177-PSMA and Lutetium-177-Dotatate are considered drugs under the current European legislation.
When is a treatment with a medical isotope considered a device and when a drug?
The classification medical device or drug has implications for the development process. What are the differences ion requirements for marketing authorisation, reimbursement and access?