Hi Vango and Tricky, You're right that VG was classified as a...

Hi Vango and Tricky,
You're right that VG was classified as a device by MHRA. The problem for us occurs in the fact that there are sub-classifications of devices. VG fits into the sub-classification that it contains an "ancillary medicinal substance". This necessitated a referral to EMA but doesn't make the classification unique because EMA has a number of these sorts of referrals each year (generally around 2 or 3). EMA struggled for a while with the classification but as Vango points out, they don't have the right to overturn the MHRA decision. They therefore have to follow their usual processes which are largely based on ensuring the safety of the device.

Let's hope that has now been established to their satisfaction.

Rev