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Class IIb Medical Device using Annex II route - Need to Update ISO 13485 Scope?

B

brandtpeters

#1
Hello, we wish to register a new Class IIb medical device. We wish to use the Annex II route. We have created a technical file in order to self declare.
This new medical device isn't covered by the scope of our existing iso13485 certificate, therefore do we have to update the 13485 scope before we can attach a CE mark?

Thanks
 
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chris1price

Trusted Information Resource
#2
I dont think you have to wait until you have updated your ISO13485 certificate, you just have to operate the ISO13485 system for the product.

However, you do have to wait until your Notified Body has updated the scope of your CE Certificate. Only then can you sign your Declaration of Conformity and sell the product.

Chris
 

Peter Selvey

Staff member
Super Moderator
#3
As Chris mentioned, the ISO 13485 certificate is not the key point here.

Your Notified Body should have issued you with an "Annex II certificate" or some kind of certificate attesting to compliance with relevant requirements of Annex II. For a Class IIb device, this Annex II certificate needs to be updated before you can legally market the device, as described in Article 11 of the directive.

They may also issue an ISO 13485 certificate but this is voluntary at least with respect to the European MDD. But, the processing of certificates is usually combined so you may as well update both certificates at the same time.
 
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