ISO 13485:2016 Certification Scope

#1
Hi Everyone,

We are a medical device manufacturer for class I and class II medical devices who implements ISO 13485:2016.

I am hoping you could provide some clarity around the scope of our ISO 13485 certification. Our current 13485 certificate issued by a notified body only covers scope of Design, production and distribution of class II medical devices, and there is no mention of class I medical devices.

I understand that as part of the conformity assessment procedures class I devices do not require a conformity assessment certificate and therefore class I medical devices is not included.

However when looking at the two documents together, nowhere does it state that we maintains a quality management system which covers class I. I understand class I is self certified however our QMS is applied to all medical devices and auditors look into all classes in an audit.

So shall we ask for an update for the ISO 13485 certificate to include Class I medical devices in the scope?
If not, is there any guidance or reference to auditing organizations to not include class I in the scope and what is the reference for this information?

I appreciate your help!

Thank you!
 
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Sidney Vianna

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#2
So shall we ask for an update for the ISO 13485 certificate to include Class I medical devices in the scope?
The scope of certification is up to your organization. If you include the Class I MD product line, will the headcount of the employees increase significantly? If so, the CB audit could be longer and co$t you more.
 

chris1price

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#3
Hi, you may be confusing your ISO13485 certificate with your CE Mark certificates for MDD/MDR. ISO13485 certificates do not usually mention the classification of the products being manufactured, just a description of the products and/or their use.

You may have different CE Certificates for different certification routes, ie one certificate for Annex II and another for Annex V of the MDD. These will be applicable to the class of device.
 
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