EUDAMED – The countdown is on! Making the leap from GUDID to EUDAMED

Lionel Tussau
März 3, 2021

EUDAMED is getting closer every day and testing is about to restart for the last UDI registration playground before going live in a couple of months. Time is getting short for companies to get their processes and UDI data in order. How to be compliant with the MDR regulation is an increasing concern for manufacturers and will have a direct impact on our personal health. This was also intensively emphasized by the authorities and the healthcare community in regard to the recent pandemic.

One important piece of advice is to look at MDR/EUDAMED compliance as part of the global picture of being UDI compliant globally, with new UDI regulations emerging regularly on all continents. Understanding the key differences between regulations and requirements is key, in order to design the right processes and quality management systems, and ensure you get the right level of expertise and support. 

To help the industry with the required next steps, atrify has published the ebook “EUDAMED – The Countdown is on!” to help you getting ready for EUDAMED.
Download the free ebook.

atrify will host a joint Online Session “Evolving Global UDI Requirements for Medical Devices” with Jay Crowley from USDM on March 11, 2021 (both at 2 p.m. CET – Brussels time, and 2 p.m. ET – New York time). Register now for the Online Session.

UDI is here to grow, and you can rely on us to keep supporting you on this journey.

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Lionel Tussau

Lionel Tussau

Lionel Tussau leitet Healthcare-Initiativen bei atrify, sowohl für die Anbindung an regulatorische UDI-Datenbanken (wie EUDAMED) als auch für GDSN-Projekte zwischen Herstellern, Großhändlern, GPOs und Krankenhäusern. Er vertritt außerdem atrify bei MedTech Europe, als Vorsitzender der EUDAMED IT Expert Group und ist Beobachter in der EUDAMED MDCG Arbeitsgruppe. Bevor er vor mehr als zehn Jahren zu atrify kam, war Lionel 16 Jahre lang in der FMCG-Branche tätig, wo er kollaborative Supply-Chain-Projekte und die Implementierung von GS1-Standards leitete.

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