CER: can "state of the art" help to make up for literature search on equivalant devices?

#1
Hello, we are Class iia devices manufacturer. During the process of establishing clinical evidences (formulating CER), we made great effort to search literature of equivalent devices. However, for some features, there are no related literatures. Could we instead use the content of (may be literature as well) of the state of the art to fill in the gap? Thanks.

Previously, we noticed that, accroding to MDCG2020-1, "Even if equivalence cannot be established, literature searches can be used to establish a valid clinical association and perform the SOTA evaluation. This principle can also be applied to other low-risk devices in the absence of specific guidance. "
 
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#2
Hello and welcome,

Did you check MDCG 2020-6? It might help answer this question. If the guidance does not apply since your device is new, then it's also easy: create your own clinical data.
By the way, this is what your clinical evaluation during (early) development is for: Identify gaps in your clinical data you have to find a way to fill for final submission.
 
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