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CE marking for general IVD (self-certified) & ISO 13485 QMS requirements - auditing

chr72

Registered
#1
Hello,

We are currently implementing a QMS according to ISO 13485 for our software IVD product, that we are developing in-house.
Our product is classified as a General IVD (self-certified) under the current EU IVD Directive, meaning that a Notified Body is not required for CE marking.
Internal auditing is a requirement of implementing ISO 13485. However, do we need to implement an internal auditing process before we self-certify and affix a CE mark to our product?

Thanks in advance for your help!
 
#2
You will not be certified to ISO 13485 before implementing an internal audits system.
It's best to do internal audits before commercialising (makes sense) although not explicitly dictated in the regulation.

Shimon
 

chr72

Registered
#3
Thanks for your quick reply! My question was more to do with the requirement for auditing in line with CE marking for a General IVD.
For example, would the following be acceptable:
1. Set up QMS and conduct product development processes etc. accordingly
2. Self-certify & affix CE mark to product
3. Initiate internal audits system
4. External audit & ISO 13485 certification
 
#4
I would put "Initiate internal audits system" before "Self-certify & affix CE mark to product", and make sure the internal audit covers include EU IVD Directive requirements.

Cheers,
Shimon
 
#5
While the IVD Directive does not mention internal audits, Annex III (EC DoC) para 4 talks about "ensuring that the manufacturing process follows the principles of quality assurance". I would suggest the only way to ensure this is met (and all the other requirements are met), is through an Internal Audit process.
 
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