TBMK. IANAL. TSI could launch case because the EMA were...

TBMK. IANAL.
TSI could launch case because the EMA were seemingly try to overule the determination of the competent body BSI. (aka the actual determination of device status was BSIs.)

Process.
TSI proposes "Rule 8 ? because ... "
Relevant competent body of expertise BSI, says sure, that looks right (or says (if they think it) "nah that was close but its really this." I think the classification did slip sideways a little. AKA BSI didn't just rubber stamp it.)
EMA does their part (risk benefit?), which they currently are.

TBMK, the reason the process is like that.

As BSI people are in the field, facing people with ulcers that need treatment, thus while they are the expertise on is this a device or not, they however are not at arms length and plausibly susceptible to motivated reasoning ("I want there to be a solution for venous leg ulcers.")
EMA are the other side of a Chinese wall, so they make the value judgementy part.

Not really seeing anything behind what Tim is saying at all.

DYOR.