By Robert Zott, Director of Advisory Services Development
Originally published March 27, 2018
It’s easy to read Europe’s Clinical Evaluation Guidance Document MEDDEV 2.7/1 Revision 4 (referred to as “Rev. 4”) and come away with the impression that clinical data—whether in the form of investigations carried out by the manufacturer of a medical device or published literature on the subject device or an equivalent—is required in order to meet the guidance.
While clinical data is required for manufacturers of high risk devices and implants, the vast majority of manufacturers that make low-to-medium risk devices may not need to conduct clinical trials for their products or produce peer-reviewed literature that supports their clinical use.
This article helps identify the specific clauses of the guidance document and regulations that pertain to clinical data and explores alternative pathways to compliance.
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