Eudamed update: Additional data entry modules now online for European medical device, IVD registrants

European Commissioners have launched additional modules for the Eudamed medical device and in vitro diagnostic (IVD) product database developed to improve European market transparency.

According to a European Commission update to the Eudamed overview page, two additional modules out of a planned six have gone live in early October: UDI/Devices Registration as well as Notified Bodies and Certificates. The launch of these modules follows the rollout of the Actor Registration module in December 2020.

This means that Economic Operators—manufacturers, EU Authorized Representatives, importers and distributors—as well as Notified Bodies may begin entering data on a voluntary basis pertaining to these modules:

• UDI/Devices Registration: Economic operators will enter UDI and registration information for devices into this module
• Notified Bodies and Certificates: CE Mark certificates as well as quality management system certifications issued by EU Notified Bodies will be entered into this module

Three additional modules—Clinical Investigations and Performance Studies; Vigilance and Post-market Surveillance; and Market Surveillance—will launch when the Eudamed database becomes fully operational in May 2022.

Additional Eudamed and EU medical device regulatory resources from Emergo by UL:

• European Medical Devices Regulation (MDR) compliance resource center
• EU In-vitro Diagnostic Medical Devices Regulation (IVDR) preparation and compliance resource center
• European Authorized Representative (EC REP) in-country representation
• Whitepaper: The role of Eudamed under the MDR and IVDR

Related services for Europe:

• CE Mark Certification for Medical Devices
• Clinical Evaluation Reports (CER) for Medical Devices in Europe
• EU IVDR Gap Assessment and CE Transition for IVD Companies
• EU MDR compliance consulting for cosmetic and aesthetic products
• EU Medical Device Vigilance Reporting in Europe
• EU Post-Market Clinical Follow-up Studies (PMCF) for Medical Devices
• European Authorized Representative for Clinical Trials
• European Authorized Representative for Medical Device Companies
• European MDR 2017/745 Gap Assessment and CE Transition Strategy
• European Union Medical Device Classification
• In Vitro Diagnostics Regulation (EU IVDR) On-Site Training
• IVD Certification and Registration to Obtain CE Marking in Europe
• Medical Device and IVD Emergency Use Routes in Europe
• Medical Device Technical File and Design Dossier for EU CE Marking
• Switzerland Representative for Medical Device Companies
• UKRP and Brexit consulting for medical device companies