Hi,
In this transition period between MDD and MDR, our notified body requires us to submit all our changes and our analysis of these changes (significant/non-significant) before any release of the software product.
This situation leads us to incredible situations where the NB ends up blocking everything under the pretext that it impacts usability. Moreover, they themselves admit that they do not understand everything about our technologies. This leads to numerous exchanges by phone or email that take weeks and weeks. It's impossible to get feedback in less than 2-3 weeks and to have direct contact with the person who reviews our files. It's endless.
On our side, we want to do things right 1/ for our users 2/ for regulatory compliance.
Would you have any advice to unblock the situation please?
In this transition period between MDD and MDR, our notified body requires us to submit all our changes and our analysis of these changes (significant/non-significant) before any release of the software product.
This situation leads us to incredible situations where the NB ends up blocking everything under the pretext that it impacts usability. Moreover, they themselves admit that they do not understand everything about our technologies. This leads to numerous exchanges by phone or email that take weeks and weeks. It's impossible to get feedback in less than 2-3 weeks and to have direct contact with the person who reviews our files. It's endless.
On our side, we want to do things right 1/ for our users 2/ for regulatory compliance.
Would you have any advice to unblock the situation please?