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EUDAMED
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EUDAMED Deadlines – The Countdown Begins!
Device Registration module is now LIVE
Are you struggling to understand what needs to be done for 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 in Q4 of 2023.
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 system is published in the Official Journal of the European Union.
Innovit has 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.
What is
EUDAMED
EUDAMED is the European Database for Medical and In Vitro Diagnostic Devices developed by the European Commission.
What is
MDR
MDR (Medical Device Regulation) is Europe’s new regulatory framework which replaced the former MDD (Medical Device Directive from 26 May 2021).
FAQ – MDR / EUDAMED
Device Registration
Your answers to Europe’s Medical Device Regulation and its online system for pre-market registration of Medical and In Vitro Diagnostic devices.
EUDAMED Leadership
Council on LinkedIn
Join our LinkedIn group of EUDAMED Thought Leaders to gain insights, share ideas and experiences in implementing EUDAMED best practices.
EU Commission
published documents
Read the latest communications and guidance from the EU Commission relating to MDR application and EUDAMED data compliance.
EU Commission
technical documentation
Download your Technical Specifications, Data Dictionary, Business Rules and Enumerated Code Lists to get started with preparing your master data for EUDAMED submission.
MedTech Europe
published documents
Get the latest MedTech Europe documentation and discussion papers relating to MDR, EUDAMED other Medical Technology industry news.
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!