Full Quality Assurance Certificate

E

ElmerF

#1
Hi There,

I just have a question relating to the Full Quality Assurance certificate. We are a start up and have ISO 13485 certification. An Outsource manufacturer does our manufacturing, we only do design for class III medical devices. We are in the process of getting our CE mark for our first device. Do we get automatically get Full Quality Assurance certificate with our CE (design exam) certificate? Is it not a requirement if we have ISO 13485? Is the Full Quality Assurance certificate only required by our Outsource manufacturer instead? Have always had with my last company and it was updated as we introduced new products. We are based in the EU.

Thanks,

Elmer
 
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somashekar

Staff member
Super Moderator
#2
I have moved this thread to the EU Medical Device Regulations, for better responses.


Your route for the CE marking determines your certificate.
If you have opted for the Annex II route then your CE will be a full quality assurance certificate.
I am sure your outsourced manufacturer is also ISO13485 certified. He is not in the scope of the CE certificate as you are the manufacturer legally and not he. He can be entitled for a QMS certification, as a contract manufacturer.
 
E

ElmerF

#3
Your route for the CE marking determines your certificate.
If you have opted for the Annex II route then your CE will be a full quality assurance certificate.
I am sure your outsourced manufacturer is also ISO13485 certified. He is not in the scope of the CE certificate as you are the manufacturer legally and not he. He can be entitled for a QMS certification, as a contract manufacturer.
Thanks Somaskar,

Yes we have opted for Annex II and both we and our OMS have ISO 13485 certification. Do you mean that the Design exam certificate (or CE mark) will come with an additionla certificate (Full Quality Assurnace certificate) or is it all contained within the Design Exam cert. Do I need to make a separate application to obtain a Full Quality cert/ separate audit or is it part of the CE mark application?
 

somashekar

Staff member
Super Moderator
#4
Thanks Somaskar,

Yes we have opted for Annex II and both we and our OMS have ISO 13485 certification. Do you mean that the Design exam certificate (or CE mark) will come with an additionla certificate (Full Quality Assurnace certificate) or is it all contained within the Design Exam cert. Do I need to make a separate application to obtain a Full Quality cert/ separate audit or is it part of the CE mark application?
Your CE certificate (EC certificate) is the full quality assurance certificate. The "Annex II" and "full quality assurance" will appear on the certificate.
 
E

ElmerF

#5
Ok, thanks Somashekar,

In my previous company the Full Quality Assurance certificate (to the MDD 93/42/EEC annex II) was issued separately by our notified body as well as ISO 13485 cert and CE mark cert. I'm wondering if that is because we originally only had ISO 9001 and it was not necessary to continue to maintain the full quality assurance once we got 13485, but we continued to do so anyway.

If this is all contained within the CE cert then that solves that. Perhaps it is just dependant on which NB you use.
 

Ronen E

Problem Solver
Staff member
Moderator
#6
Hi,

For a class III device, going by annex II, you are supposed to get 1 certificate (EC certificate), stating that you comply with annex II. The "Design examination" is covered by section 4 of annex II, so basically, stating that an organization complies with annex II, without excluding section 4, covers design examination as well. The inclusion of section 4 can be explicitly stated, or not - depending on the NB.

If the NB issuing your EC certificate is also your ISO 13485 CB, you will get an additional certificate for ISO 13485 from them, with, or prior to the EC certificate. If you got the ISO 13485 certification from a different body, then obviously you will have already had the ISO 13485 certificate, and the NB will have relied on it for establishing compliance with annex II.

I'm not sure what you mean by "CE mark certificate", other than the EC certificate. Typically there are 2 certificates - The EC certificate and the ISO 13485 certificate; however, the NB may decide to issue all kinds of certificates, or provide the certification by means of more than one or two documents. I don't have experience with all NB, but I do know that NBs ways vary quite a lot.

Cheers,
Ronen.
 
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