For a NB to declare conformity of a Medical Equipment to IEC/EN 60601-1 the application of the CB Scheme is mandatory?
It´s not required, the CB-Scheme has nothing to do with any regulatory system (but please keep in mind that regulatory systems can use the CB-Scheme if they want. For example, CB-Scheme test reports are recognized in some certification programs here in Brazil, but only because the legislation say so).
Anyway, it can make it easier if you use CB-Scheme because it´s a known process and the labs are, for example, already certificed, for example by 17025.
