atrify welcomes the production go-live of the EUDAMED Actor Registration module on 1st December 2020. This is a major milestone towards enabling manufacturers to be MDR and EUDAMED compliant, ahead of the production opening of UDI Device registration and Certificates in September 2021.
Legal Manufacturers, Importers and Authorized Representatives (AR), located both inside or outside the EU (Non-EU Manufacturers) can now register as an Economic Operator and request their SRN (Single Registration Number) in EUDAMED. Please note, non-EU Manufacturers must appoint and ensure their AR is registered in EUDAMED.
Obtaining and providing an SRN is a required step in order to register UDIs in EUDAMED and will also be required by notified bodies and trading partners. Therefore, using the EUDAMED Actor Registration to obtain your SRN is a critical first step to ensure the continuity of your business within Europe. All device manufacturers should begin preparations to receive and manage their SRNs as they prepare UDIs for EUDAMED registration in EUDAMED in September 2021.
For the past year the atrify team has been assisting numerous manufacturers in the various EUDAMED activities. We at atrify are here to help you quickly become EUDAMED compliant and enable you to effectively register your devices in EUDAMED.