EUDAMED
With the application of the new Regulation (EU) 2017/745, manufacturers, European representatives, and importers must register on the European EUDAMED platform.
EUDAMED is the new European portal whose main function is to serve as a database and reference for all medical devices and the actors involved in their marketing. The assurance provided by this platform is that, prior to registration, it has been verified that both the medical devices and the actors meet the legal requirements to market the medical device; therefore, registration on this platform guarantees that the medical devices and actors meet all legal and health guarantees required to be marketed in the European Union.
EUDAMED has 6 modules: actor registration module, product registration module, product-associated certificate registration module, vigilance module, clinical investigation module, and post-market module.
To date, the actor, certificate, and product registration modules are fully operational.