By Nerac Regulatory Analysts
Originally Published: July 31, 2018
The European Clinical Evaluation Guidance MEDDEV 2.7/1 Revision 4 updated many requirements for clinical evaluation of medical devices and provided detailed descriptions of what the Clinical Evaluation Report (CER) should encompass to assess and document safety and performance of a device. In particular, revision 4 clarifies the previously brief mention of state of the art.
This article explores how to establish and document state of the art in terms of CER requirements.
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