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EUDAMED user guideMachinetomachine data exchange Production v 2.14 2024EUDAMED user guideTable of Contents 1. Glossary ..................................................................................
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What is eudamed user guide?
The EUDAMED User Guide is a comprehensive document that provides instructions and information on how to use the European Database on Medical Devices (EUDAMED) effectively. It outlines the functionalities of the database, user roles, and the processes involved in reporting and managing medical device-related information.
Who is required to file eudamed user guide?
Entities involved in the medical device sector, including manufacturers, authorized representatives, and importers, are required to file information in EUDAMED as per the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
How to fill out eudamed user guide?
Filling out the EUDAMED User Guide involves following the step-by-step instructions provided in the guide itself, which typically includes creating an account, navigating the interface, entering product details, and submitting the required data in the appropriate sections of the database.
What is the purpose of eudamed user guide?
The purpose of the EUDAMED User Guide is to ensure that users can accurately and efficiently submit, manage, and access information related to medical devices within the European market, thereby enhancing transparency and safety.
What information must be reported on eudamed user guide?
Reported information in EUDAMED includes details about medical devices, vigilance reports, clinical investigations, economic operators (manufacturers, importers), and other relevant documentation that ensures compliance with EU regulations.
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