BSI is not a consultant to anyone. BSI is a competent authority (MHRA) approved issuer of EC certs. Their job is to ensure timely patient access to medical devices with demonstrated safety, efficacy and clinical benefit. And they do an excellent job.
No other notified body will touch this with a bargepole.
Oncosil are delusional if they think the is any chance of proceeding to CE approval without an RCT. Fact.
Ann: CE Marking Update, page-80
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