Like my next post sayed morgans concerned with FDA shutdown...

Like my next post sayed morgans concerned with FDA shutdown delays applications.
And brexit delaying CE approvals these are valid concerns
My response was in there
Not sure if everyone has factored all delays into there own trading strategy
they appear to be small delays only
Like I said transfer the CE to Uk mark is still before parliament but of little concern for medical devices currently. 3 items dealt separately.
I don't see getting CE a problem and UKCA mark has no provisions for medical devices currently so CE mark should be fine in Europe and UK post brexit for this particular product. Assuming no parliamentary changes

The current path that the approval path takes given the type of product is hard to predict, just 3-5 months was the average that's all anyone can go on.

I have put June to July in my time scale to not over promise if it arrives April or May would not surprise at all.

Not investment advice, do your own research, and consult a licensed adviser