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EUDAMED Update – MDR Second Amendment is official!
Device Registration module is now LIVE
Where are you at with EU MDR compliance?
Today, medical device manufacturers are confronted with an ever-changing landscape for regulatory compliance around the globe. Faced with increasing uncertainty in terms of meeting EUDAMED compliance, device manufacturers are now counting down to a fully functioning EUDAMED system to be in production by Q4 of 2024. With the EU Commission’s current timelines, the completed EUDAMED system is expected to be independently audited and ready for production use by mid-2024 – when the ‘production ready’ EUDAMED system is to be published in the Official Journal of the European Union.
On 15 March 2023, the European Parliament passed Regulation 2023/607 (aka Second Amendment to MDR) to extend the transition timeline for medical devices already in circulation in the European markets. This amendment also abolishes the requirement to “sell-off” for any devices placed into the market prior to MDR or IVDR came into effect.
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!