Hi Supertramp, EMA assigns the work of looking into the...

Hi Supertramp,

EMA assigns the work of looking into the applications to "Rapporteurs". These guys provide a report back to the CHMP including a recommendation. The recommendation can either be to ask a number of questions of the manufacturer or address issues or after all of these have been addressed they will recommend an "opinion" be given by CHMP. The CHMP then meets and hears from the rapporteurs and decides whether to adopt the opinion. In almost all instances this is a positive opinion. This means that CHMP does not grant the CE Mark itself but provides a positive opinion to the notified body (BSI) that a CE Mark should be granted.

As far as I can tell the CHMP agenda will indicate one of two things. Either:
"opinion: For adoption"
or "List of outstanding Issues: For adoption"

Although VG has already once provoked a list of outstanding issues it is possible for a second list to be issued as happened for another device in December. This usually has to be resolved within 1 month.

The only other risk is that when it says "opinion: for adoption" it is possible that the recommendation could be a 'negative' opinion.

Hope that provides some clarity,

Rev