change in medical device classication?, page-7

There announcement on 8 August indicated that the issue BSI were looking at was whether VG was under Device Rule 8 of 13.
They later said in that anouncment that: "It is possible that the MHRA review may result in a further referral to the European Medicines Agency (EMA) for a review of the VitroGro® ECM manufacturing process".

I assume TIS knew all along that the EMA referral would inevitably happen if BSI decided the classification was under Rule 13. But they never told us...

Looking at the 2 rules, I am actually amazed that they tried it under rule 8 in the first place (and surprised BSI agreed). I strongly suspect that TIS tried to slip it under the radar and they were caught out. This has cost us immensely.