The EUDAMED system has now two new modules available: UDI/Devices and NBs & Certificates. This allows Economic Operators and Notified Bodies to start entering data on a voluntary basis.
Additionally, the Medical Device Coordination Group (MDCG) has released a new revision of its Q&A document on requirements relating to notified bodies. This document can be found on MDlaw’s Library of Documents for both IVDR and MDR.
Are you a manufacturer of medical devices? We will gladly assist you in reaching compliance for the EU market! Contact us today!
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