Hello,
Could someone please confirm if I would need to make a submission to my regulatory body to manufacture a Class ! (sterile) device.
The device does fall within one of our Annex V scope product descriptions. It is a new product within this generic grouping (ie different materials, and a few different components)
I am confused as to if I need to make a formal submission to them and at what level, as technically its not an addition to scope.
Thanks in advance
J1980b
Could someone please confirm if I would need to make a submission to my regulatory body to manufacture a Class ! (sterile) device.
The device does fall within one of our Annex V scope product descriptions. It is a new product within this generic grouping (ie different materials, and a few different components)
I am confused as to if I need to make a formal submission to them and at what level, as technically its not an addition to scope.
Thanks in advance
J1980b