Thoughts...

Thoughts abound:

http://medicaldevices.bsigroup.com/pdf/Critical%20Launch.pdf

the above link indicates a CE Mark can be achieved (fast tracked) within 45 working days...I assume this is if everything is correct.

From the 1 June announcement SM states:

“After making recent enquiries of the Notified Body assessing the application for CE
Marking of VitroGro® ECM, we have been informed that the reviewers will request
additional information”

So as of 1 June the requests had not been made nor had the additional information been provided.

We can only assume that this information has now been provided but unsure as no announcement states it has...does anyone know for sure ?

However, for arguments sake would one still expect a fast track assessment of the CE Mark from the week after 1 June (supposedly when TIS might have submitted the additional requested information),if so receival of the CE Mark may not be until 10 August (45 working days = 9 weeks).

Someone may know the workings of CE Mark process better and be able to provide working experience of the process.