Making the leap from GUDID to EUDAMED
EUDAMED, a crucial element in the European Union’s Medical Device and In Vitro Diagnostic Registrations (MDR and IVDR), has already started launching its module-by-module go-live with the Actor Registration module’s release in December 2020. Next up are both the UDI and Device Registration along with Certificates modules go-live in September 2021 and complete go-live of all six modules by May 2022. This means that in a short time, manufacturers will have the ability to start registering MDR and IVDR products in EUDAMED.
Testing reveals that manufacturers are missing nearly 60% of required EUDAMED information in their internal systems.
Based on our experience gained with device manufacturers who successfully tested with the three previous EUDAMED Device Registration playgrounds using atrify, we’re happy to share our experience and key learnings with the broader community to become compliant with EUDAMED requirements.
You need to be compliant with MDR Date of Application (September 2021)
– We show you how!
This eBook covers the following topics:
- What is EUDAMED?
- Difference between EUDAMED and FDA’s GUDID.
- How to get ready: Key learnings from EUDAMED and important dates.
- Device Testing Results: See why manufacturers are missing nearly 60% of required information in their current data systems.
- EUDAMED is just the beginning: See what countries are on the horizon and how a Global data readiness strategy can ensure future success.
- EUDAMED Readiness Checklist: Start to get a handle on EUDAMED today
Download free eBook + checklist now
Regardless of whether your based in the EU or selling to the European market: if you want to continue selling your products within the EU, you need to comply with EUDAMED regulations. But how do you manage to be compliant in time?