i agree that if only safety had to be proven, the timeline would...

i agree that if only safety had to be proven, the timeline would be shorter, but my understanding of the ce mark for class 1 implanted medical devices is that the company has to demonstrate both "safety and clinical performance".
i am being optimistic that they would accept 8 week ct results as evidence of clinical efficacy/ performance but i think it is possible.
to say it is purely safety without efficacy is not my experience of the process.
see the following link for an up to date guideline re class 1 med devices from EC:

http://ec.europa.eu/DocsRoom/documents/17522/attachments/1/translations/en/renditions/native

im happy to be corrected if im wrong as i believe the product is fundamentally promising in a challenging clinical situation with limited existing treatments.

but i require more evidence from the above posters producing documents or links that demonstrate the ce mark is purely about safety with no consideration of equivalence or performance.

all the best,
savvy