This is an unusual outcome.
In my understanding, it has always been clear that CE marking relates to safety and technical compliance.
It is the FDA that requires the additional burden of clinical efficacy.
That's why a CE mark is both easier to obtain and less valuable.
I have never actually heard of the CE mark requiring clinical trials of efficacy.
It may be that this subcommittee is asked to make a determination on efficacy regardless, but unless the CE process has changed significantly, it might hopefully be less important than it seems.
This is an unusual outcome. In my understanding, it has always...
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