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EUDAMED Deadlines – The Countdown Begins!
Device Registration module is now LIVE
Are you still struggling to understand what steps need to be taken for EU MDR?
Today, medical device manufacturers are confronted with an ever-changing regulatory compliance landscape around the globe, and facing increasing uncertainty in terms of meeting the EUDAMED compliance challenge, with the Device Registration module live as of October 2021 for voluntary UDI data submission, we are now counting down to a fully functioning EUDAMED system in Q4 of 2022. With current timelines, a fully functional EUDAMED system is expected to be ready for production use by mid-2023, when this system is published in the Official Journal of the European Union.
Innovit have you covered, with all the information and tools you require today, to meet evolving Medical Device Regulations (MDR) and EUDAMED compliance. So bookmark this page as your launch pad to find everything you ‘need to know’ about EUDAMED and your quest for compliance.
EUDAMED M2M Testing – An Unexpected Journey!
Innovit leads the pack in M2M testing for Device Registration.
In order to ensure a smooth and effective implementation, the EU Commission is providing its “EUDAMED playground” to test both manual web-based user access, as well as automated M2M (machine‑to‑machine) data exchange for Actor Registration, Device Registration, and Notified Bodies modules.
Three solution providers – including Innovit – were invited to participate in this testing program and were approved to have Access Points setup for testing M2M data exchange with EUDAMED. Find out what we learned!