The latest announcement said,
"...The CEO of Tissue Therapies, Dr Steven Mercer said that the Company had answered in full all questions
raised by BSI.”
“There are no outstanding issues or requests and we are confident that CE Mark will be granted during
July,” he said."
So the information has been provided.
Re CE-45 FastTrack,
"...BSI does not guarantee a CE Marking certificate in 45 days, but to complete the review process with either a positive or negative recommendation."
So that means that the 45 days refers to the review process, not approval. I can't see any reason why you would restart the clock for another 45 days. SM referred to the type of request for more info suggesting the substantive issues had been sorted out.
I take that to mean the question related to QA procedure.
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