MDCG 2024-4 - Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746 - April 2024
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21 mai 2024
- doi: 10.58079/11p07
info:eu-repo/semantics/openAccess
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« MDCG 2024-4 - Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746 - April 2024 », ELSIBI, ID : 10.58079/11p07
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Résumé
Since the electronic system referred to in IVDR Article 69 (Eudamed and its module for clinical investigations and performance studies) is not yet available and fully functional from the date of application of the IVDR, this guidance outlines the procedures for safety reporting in performance studies in the absence of the Eudamed module or when Eudamed is not yet fully functional. This document defines serious adverse event reporting modalities and includes a summary tabulation reporting for...
