(iv) ISO-10993, Biological Evaluation of Medical Devices, should be followed for conducting bio-compatibility study for invasive medical devices should be carried out. A report of bio-compatibility study along with rationale for selecting specific tests carried out should be prepared including conclusion of the study. 7.3 Medicinal substances: Where the medical device incorporates a medicinal substance, the dossier should provide detailed information concerning that medicinal substance, its identity and source, the intended reason for its presence, and its safety and performance in the intended application.