by Innovit Corporate Affairs | May 28, 2019 | Blog, Eudamed
As it prepares to meet new regulatory requirements in Europe, the medical device community is following developments regarding the European Database for Medical Devices (Eudamed). Most recently, the European Commission (EC) released three documents for Medical Device...
by Innovit Corporate Affairs | May 21, 2019 | Blog, UDI
Recently, the FDA issued the final guidance, “Unique Device Identification: Convenience Kits” to help clarify the FDA’s policy related to UDI considerations for medical procedure kits. The intent of this guidance is to ensure that the exception for UDI labeling of...