”Inadequate” suits your slant against this co. Yes it has dragged out with the forever “imminent” mantra wearing thin but another view is that it has plenty to do with the new, much stricter medical device regulations whose three year transitional period comes to an end in May this year therefore become actual EU law.
As stated in several company announcements the Oncosil device is an active implantable radioactive medical device. This is the highest class category for CE Marking. It is a unique, 1st in Class therapy (class III). By its very nature this leads to a complex, challenging and lengthy CE Mark review process. So the tightening of regulations has made the process even harder.
In particular...”Vigilance and Post-market Surveillance: PMS plan and report, Periodic Safety Update Report – PSUR for Class IIa, IIb and III medical devices and EUDAMED (European database for Medical Devices) are introduced”
“Summary of Safety and Clinical Performance: For implantable devices and for class III devices the manufacturer shall draw up a summary of safety and clinical performance and make it available via EUDAMED.”
”Clinical Evaluation and Clinical Investigation: “Expert panels” for Class IIb implantable and Class III. Clinical investigations and Post Market Clinical Follow-up (PMCF) will be required in more cases.”
OSL Price at posting:
14.0¢ Sentiment: Hold Disclosure: Held
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