That’s precisely the problem here Suzuki. OSL reckon they have more than satisfied the protocols etc. BSI have other ideas. Unlike the FDA which is much clearer as to what the requirements are ie Controlled study etc with 2 separate groups one with the Oncosil device and the other without. The Europeans appear to be more vague.
With the value of hindsight, Oncosil would have been better off going for FDA approval rather than EU approval.
Ann: CE Marking Update, page-11
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