Sufficient levels of access to data needed to justify claims of equivalence
Update: 2024-07-05
Description
In this episode of MDR Chats, host Oliver Harris interviews an expert about the MDCG 2023-7 guidance document. They discuss the concept of ‘sufficient levels of access’ to data needed to justify claims of equivalence for medical devices, exploring the types of data required, methods of demonstrating access, and the implications for manufacturers. This episode provides essential insights into ensuring compliance with EU medical device regulations and maintaining high standards of safety and performance.
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