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First of all: My understanding is, that a class Is product would normally go the route according to Annex VII.
Situation:
- A product is classified as a class Is device
- The ISO 13485 certificate states:
Does this mean that
a) the combination of Annex II and Annex V covers a class Is device?
b) the Annex II and V overrule Annex VII in this case?
I am a little confused
Thanks for your help
Situation:
- A product is classified as a class Is device
- The ISO 13485 certificate states:
- several products (sterile and non sterile)
- Annex II (except 4) and Annex V sterility aspects only.
Does this mean that
a) the combination of Annex II and Annex V covers a class Is device?
b) the Annex II and V overrule Annex VII in this case?
I am a little confused
Thanks for your help
