It was also discussed briefly at the AGM. In essence, companies are finding that the traditional pathway to regulatory approval and commercialisation through CE Mark first then FDA is starting to shift.
It was reasonable to approach the EU for CE Mark first, despite a smaller market, on the basis that the CE Mark was quicker and less costly.
However, this is starting to change substantially with significant delays and expanded but unclear standards and also the involvement of notifying bodies as middlemen instead of dealing directly with the regulator (Oncosil and others as cases in point). As that article suggests, companies might just skip CE and start aiming for FDA clearance first.
As usual, EU shoots itself in the foot.
But, it means that the CE mark is actually worth more once achieved because it will be harder to get. Potential partner companies will pay more attention.
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