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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.

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.

The EUDAMED
journey

Join us to learn about best practices and share the experience of global Med Devices leaders as we take you on a journey to EUDAMED compliance.

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.

EUDAMED
playground

Your very own playground environment to gather, validate and test the submission of device registration data for EUDAMED compliance.

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!

The EUDAMED FAQ eBook

Today, Medical Device manufacturers are staring down the barrel of a number of critical compliance deadlines specific to EUDAMED (European Database for Medical Devices). Having the right processes and systems can simplify this journey substantially.

This eBook is intended to serve as a reference tool and mini-guidebook as your team navigates the complexities of Medical Device Regulations (EU-MDR).

Download the eBook