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EU’s Medical Device Expert Panels: Analysis of Membership and Published Clinical Evaluation Consultation Procedure (CECP) Results

2023-12-07

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<title>Abstract</title> <p><italic>Background</italic> The new EU Medical Device Regulation (MDR) places greater importance on the role of clinical evidence to establish safety and performance. Article 54 of the MDR calls for expert committees to independently review the scientific, technical, and clinical evidence supporting the market authorization of certain novel devices independently from the established pro...

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Literature Corpus work: e57d020f-34e9-5726-b600-d4e09e539747
DOI: 10.21203/rs.3.rs-3507996/v1

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