Everybody should know by now that the EUDAMED UDI module for device registration is up and running since 4th October 2021 – in a voluntary mode from the European regulation perspective, in a mandatory or close to mandatory mode according to various European Member States, including prominent ones. As a reminder, being 5 years after the MDR went into force, all medical devices should already have been registered in EUDAMED for all classes as per the original deadlines!
The next step for manufacturers is to move from testing with the Playground provided by the European Commission since 2019, to starting to use EUDAMED in real life – and that is where things are getting much more difficult, with increasingly complex requirements elaborated on a regular basis by the European Commission and Member States (the so-called “MDCG guidelines”), technical specifications that keep changing and whose up-to-date version is not necessarily publicly available in official websites, “hidden” interdependencies between EUDAMED modules and within modules that are not documented and only known to the experts who have been testing with the European Commission and EUDAMED for the last couple of years… And speaking of expertise, manufacturers are confronted everyday with potentially confusing or misleading information regarding EUDAMED. So what should manufacturers believe, and how can we find trusted information to implement EUDAMED?
It is indeed crucial to be able to rely on a trusted partner who has proven experience of successfully working with the EUDAMED ecosystem over a long time period. The good news is that atrify, as part of the few companies authorized by the European Commission to participate in the official EUDAMED playgrounds, have been testing extensively with a large number of all size manufacturers for years now. We are proud of being regularly invited to share our unprecedented experience in this area with the market and the industry in general, but also other actors such as Notified Bodies, regulators across the world and GS1 organizations. Thanks to the constant support of the European Commission during the testing, the Industry associations and our customers, we are here to help any medical device manufacturer to navigate through the EUDAMED ordeal and ensure trusted, safe and cost-effective UDI registration in compliance with the European MDR and IVDR.
atrify is also co-chairing the MedTech Europe “EUDAMED IT Expert” group, and a member of GS1 Global Healthcare Leadership Team. Based on this experience, atrify have developed the UDI Solution to register your medical devices compliantly, quickly and easily in EUDAMED. Whether via M2M connection or manually via user interface and excel upload, we have the right solution according to your needs.
Request afree consultationwith one of our experts to understand how to register your medical devices. Let us tackle your EUDAMED Challenge together!
