Our Audit was last year in December. Unfortunately we are still waiting for our certificate. We are manufacturer of class IIa medical devices in Germany.
The Tech file review lasted about 3 month. Our NB is TUV.
I recommend an intensive exchange with the notified body and the responsible auditor. This helped us a lot!
Important topics are:
-Vigilance
-Post Market Surveillance: PMS, PSUR, PMCF
-UDI, MDRLabeling