RE: ODX...GAD....USA...is this our route to USA?8 Jun 2021 10:45
@jdt. There is a distinction to be made between UK 'home-use' and European 'home-use'. I think the lengthier home-use approval AS was referring to in the presentation was the UK 'home-use' approval.
The article I posted from the Spanish notified body, states that there is only a need for 'notified body' involvement, where the application is for 'home-use' approval (European home-use, that is). There is no need for 'notified body' involvement for 'professional use' in Europe, it's a given once CE is achieved.
By deduction, we have to assume by involving an EU notified body, Avacta have in fact applied for European 'home use' approval in early May - UK 'home use' to follow later in the year, as you say.
Read of my post 02 Jun 10:50 re: Spanish notified body.
https://www.lse.co.uk/profiles/scardey_cat/?page=3