Posted By
Beat Steffen
15-Sep-2022 21:05
Found In
Egroup:
Regulatory Open Forum
\
view thread
Dear Bob, This is correct. The Notified Body assesses the technical documentation of the manufacturer / MAH and, if all applicable requirements of Annex I (General Safety and Performance Requirements) are met, issues a Notified Body Opinion (NBOp). Unless there are significant changes, this is a one ...
|