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93/42/EEC certification without ISO 13485

Nuno_

Registered
#1
Hi all.

A question arose today that I hope someone can answer.
We've been struggling with our NB for a remote audit for an MDD certification that has been postponed due to the pandemic, and last week they finally said yes.
However when asked they said that the audit was only for 93/42 / EEC certification, and that they could not audit to certify our ISO 13485 QMS.
So my question is this: is it possible to have a 93/42 / EEC certification (class III MD) without ISO 13485 certification?
What is your opinion?
 
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primavesvera

Involved In Discussions
#2
In the MDD conformity assessment annexes, you have some requirements that are related to the QMS which correlates to the ISO 13485 requirements. For example, our auditor insisted we use the EN ISO 13485 because of Annex Z (in our case, for device class II and Annex II ZB.1) where you have this connection between MDD Annex paragraphs and clauses of ISO 13485.
When it comes to the Essential Requirements and how you fulfill them, we stated the ISO 13485 certificate for some points. In this case, you would probably need to find alternative way to demonstrate how the essential requirement is fulfilled.
 

chris1price

Trusted Information Resource
#3
Yes, you can have a MDD certification without ISO13485. The requirement is that you have a quality system, the directive does not say which one. However if you are certified to ISO13485 there is an automatic presumption that you meet this requirement. If you are not certified, then the NB has to assess your quality system for suitability.
 
#4
Thanks for the clarification chris1price. This is also my understanding, but there are divergent opinions within my company. In fact, I asked for more clarification from our NB, who explained that they are going to audit the quality requirements described in Annex II of the MDD. But it is the first time that I will see a class III device enter the EU market (I hope :) ) without ISO 13485 certification.
 
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