Notified Body Involvement with Self Declared Products

Mor628

Involved In Discussions
#1
Hi guys,

If one of our Class I (self declare) products has a significant complaint (patient at risk, national authority is notified), is there auditor then allowed to question us on it even though it is not on our ISO 13485 scope and therefore not one of the products on their sampling list.

How much can the auditor be involved in those products that are self declare? Are self declare products subject to the same audit procedure as Class Is?
 

Marcelo Antunes

Addicted to standards
Staff member
Administrator
#2
Not sure how a medical device is not in your ISO 13485 quality system (or you mean it's not on the scope of the certificate? Anyway, it's weird).

Anyway, in regards of compliance with the directive, the NB is not involved in any step of the regulatory compliance, so they in principle Ould not be able to ask anything. But then again, if you have both self declaration products and other products, I don't think it would be possible to separate that, for example, in the QMS level.
 

Mor628

Involved In Discussions
#3
Hey Marcelo,

Yes, it is not on the scope of our ISO 13485 certificate.

If it is not included in our ISO 13485, then it is not included in our QMS as well right?
 

Marcelo Antunes

Addicted to standards
Staff member
Administrator
#4
Hey Marcelo,

Yes, it is not on the scope of our ISO 13485 certificate.

If it is not included in our ISO 13485, then it is not included in our QMS as well right?
Well, unless you explicit mention it in your QMS (not on the QMS certificate), it will be part of the QMS. You may have a certificate that does not include it, but the certificate would only refer to the exclusion of the QMS (the certificate itself cannot simply exclude things that are not excluded in the QMS).
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#5
why would a product that is registered as class I, self declared not be in your QMS scope? I know that ISO 13485 is voluntary for this but why exclude it if you have ISO 13485 registration?

otherwise I'm with Marcelo - If this product is not specifically excluded from the scope of the QMS in some way I believe your NB can examine it and any complaints that result from it. I know I would if I was an auditor in this situation because I would want to see the effectiveness of your complaint handling system.
 

Sidney Vianna

Post Responsibly
Staff member
Super Moderator
#6
If it is not included in our ISO 13485, then it is not included in our QMS as well right?
Scope of certification and scope of the system are distinct things.

So, you are saying that your organization designs, produces and sells a medical device, but that device is not covered under ANY quality system? From a risk-based perspective, that doesn't make ANY sense.

If you want an opinion about the adequacy of the external auditor assessing the system as it relates to this device, please post EXACTLY what is the scope of certification with any current exclusions.

Also, if your organization makes claims about being ISO 13485 certified in ads or promotional material, does it disclaim the exclusions?
 

moounir

Starting to get Involved
#7
Hi,

I think there is a misunderstanding between 2 things.
You have usually 2 certificates:
- CE Marking certificate
- QMS Certificate

I agree that your class I self-certified product is out of scope for the CE Marking Certificate.
But your QMS is the global law putting in place a system for all your company. So your class I product is included in this system. The QMS is not making a distinction between Class I or Class III products. So I am also with Marcelo. Your NB can ask you questions on your product not under CE Marking but on the scope of QMS.

So if you receive a lot of complaints regarding this product, your QMS should tell you which step you have to follow. And this is what the NB will be looking.

I hope this clarifies your problem.
 

rob73

looking for answers
#8
We had a similar situation, there was an MHRA report (not serious) on one of our Class 1 devices, when this was picked up at an audit the auditor wanted to know why they were not informed. The scope of their certificate was for a Class 1m device not the reported device, the auditor was happy that they did not need to be informed, but still looked at the CAPA as part of our 13485 audit.
 
Top