MDCG 2023-3 rev.1 - Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 under Regulation (EU) 2017/746 - November 2024
Year: 2024
Type: other
Abstract: The document aims to clarify important terms and concepts that are outlined in Section 2 of Chapter VII of Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices. Establishing a common understanding of these terms and concepts is necessary for the effective and harmonised implementation of the vigilance requirements under these Regulations. Read the news announcement published by EC Directorate-General for Health and Food Safety on 11 ...
DOI: 10.58079/12vxj
Author: Lsgilbert
Language: English
Topic: Healthcare Regulation
Subfield: Health Information Management
Field: Health Professions
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W6955288423
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