EUDAMED, a crucial element in the European Union’s Medical Device and In Vitro Diagnostic Registrations (MDR and IVDR), is expected to launch its module-by-module go-live in production within the next few months. The Actor registration module will already be released in December 2020, and UDI device registration and Certificates modules are scheduled for September2021, before full production is reached by May 2022. This means that in just a few months, manufacturers will have the ability to start registering MDR products in EUDAMED. Based on our experience gained with a significant number of device manufacturers who tested with the 3 previous EUDAMED playgrounds using atrify, we’re happy to share our key learnings with the broader community to become compliant with EUDAMED requirements.
Take 2 minutes to find the optimal solution for the registration of your medical devices.
You want to register your medical devices in a national UDI database like EUDAMED or GUDID (FDA) or share them with business partners worldwide, but d...