You should ask the NB who issued your EC certificate if they will accept the SCC one. Please also consider that you might need ISO 13485 certification for other markets.
Normally when being EC certified you get 2 certificates - one for EN ISO 13485 and the EC certificate. Usually they both originate from the same NB audit (but not necessarily).
Cheers,
Ronen.
Hi Ronen,
The same NB issued all 3 certs from the same audit.
My two ISO 13485 certificates look like this:
First one -
"the management system of [company/address] has been assessed and certified as meeting the requirements of
ISO 13485:2003
EN ISO 13485:2012
for the following activities
(activities)
(expiration)
(NB address) (UKAS stamp)"
Second one -
"the management system of [company/address] has been assessed and certified as meeting the requirements of
ISO 13485:2003
for the following activities
(identical activities)
(expiration)
(registrar address) (SCC stamp)
CMDCAS recognised registrar"
In what market would the second one be rejected?
It still seems to me that I should be able to satisfy all regulatory authorities with the EC certificate and the second ISO 13485 certificate. Two ISO 13485 certificates seem like overkill!