Hello,
I work for a company which creates software that is very similar to the examples given in MDCG 2019-11 - Modules. The application consists out of many modules, from which only some have a medical purpose and qualify as a SaMD.
At present the whole solution is CE marked as a Class I device and we would like to migrate towards a scenario where only the relevant modules bear CE marking.
How would we best approach this? Can we update our existing notification and more clearly delineate and define what falls in scope or should we cancel our current CE marking and notify each of the modules as separate devices?
Any insight is greatly appreciated!
KR,
Arne
I work for a company which creates software that is very similar to the examples given in MDCG 2019-11 - Modules. The application consists out of many modules, from which only some have a medical purpose and qualify as a SaMD.
At present the whole solution is CE marked as a Class I device and we would like to migrate towards a scenario where only the relevant modules bear CE marking.
How would we best approach this? Can we update our existing notification and more clearly delineate and define what falls in scope or should we cancel our current CE marking and notify each of the modules as separate devices?
Any insight is greatly appreciated!
KR,
Arne