Non-Conformity Overreach - We recently switched our EU Authorized Representative

joemar

Involved In Discussions
#1
Hi all,

Im just posting to discuss a non-conformity that I received that seems pretty dumb to me. We just had an annual surveillance audit, and it went well overall. I think, as a result of finding so little, the auditor started to go fishing. He gave us the following (paraphrased) non-conformity (category 2):

We recently switched our EU Authorized Rep. We did this because the previous Authorized Rep was a distributor, and we just wanted to get in line with a higher level of regulatory standard. So we are now using a respected EU Rep. The non-conformity was that when we changed, we did not put in place a distributor agreement with the previous Authorized Rep (the distributor) that mandated they continue to provide us information on customer complaints. He claimed this under Clause 7.2.3 "The organization shall determine and implement effective arrangements for communicating with customers in relation to: c) customer feedback, including customer complaints, and d) advisory notices."

So, I dont know why I didnt fight this harder at the time (probably because I just thought that I know the distributor well, and it would be pretty easy to establish communication, so it seemed easy to solve). But now that im looking at it and thinking WTF. I'm just going through MEDDEV 2.12-1 rev 8, and it's reasonably clear that the end users and distributors don't have a major role in facilitating customer feedback, and that is the entire purpose of an Authorized Rep. That's why we put their name on the label. Geesh.

And also, now I'm worried that to clear this NCR I may have to go through all my customers and establish separate agreements with them mandating they provide me notice of any complaints and feedback? Again, that's the point of the Authorized Rep, and what's already in the law.

Anyway, Im just posting to rant a little. but any feedback would be appreciated.

Thanks,

 
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Access2hc

Involved In Discussions
#2
There's a point to this. in simple language, if in the course of business when you and your distributor did not include terms that covered complaint handling, traceability, preservation of product, advisory notice, recall support etc. and solely depended on the fact that they were your EU AR, then indeed the auditor have a case. The distributor's quality system is the extension of yours, and they are technically your supplier because they supply distribution / sales / service .. that said, it also depends what kind of distributors you have - if they are retail distributors then that would be a real challenge to implement due to their setup and the 'non-medical-device' mentality. challenging, but not impossible, with amazing powers of persuasion :)

hope it helps

Cheers,
Ee Bin
Access2hc
 

Ronen E

Problem Solver
Staff member
Moderator
#3
they are technically your supplier because they supply distribution / sales / service
That would have been true if they didn't take ownership over (ie bought) the product at any stage. Namely, they would have then been termed "agents", acting on behalf of the manufacturer and only providing a service. Since they (apparently) buy the product they are customers.

Joe, the key term is "effective". If you could show that you have effective communication arrangements, you might get away with it. Mind you, it can be quite challenging, especially for actions that never actually took place (eg recall).

Please also bear in mind that you don't necessarily need to reach out all the way through to end users / retail customers. As far as I understand your regulatory responsigbility extends in this context only to your direct customers, ie entities who directly pay you for your products. That might reduce the number of distributors / customers you will need to approach. Please note that one of the implications is that your direct customers will have to have in place their own effective communication channels, to alllow information to flow back and forth (as necessary) all the way from/to the end user.

Cheers,
Ronen.
 

somashekar

Staff member
Super Moderator
#4
Hi all,

Im just posting to discuss a non-conformity that I received that seems pretty dumb to me. We just had an annual surveillance audit, and it went well overall. I think, as a result of finding so little, the auditor started to go fishing. He gave us the following (paraphrased) non-conformity (category 2):

We recently switched our EU Authorized Rep. We did this because the previous Authorized Rep was a distributor, and we just wanted to get in line with a higher level of regulatory standard. So we are now using a respected EU Rep. The non-conformity was that when we changed, we did not put in place a distributor agreement with the previous Authorized Rep (the distributor) that mandated they continue to provide us information on customer complaints. He claimed this under Clause 7.2.3 "The organization shall determine and implement effective arrangements for communicating with customers in relation to: c) customer feedback, including customer complaints, and d) advisory notices."

So, I dont know why I didnt fight this harder at the time (probably because I just thought that I know the distributor well, and it would be pretty easy to establish communication, so it seemed easy to solve). But now that im looking at it and thinking WTF. I'm just going through MEDDEV 2.12-1 rev 8, and it's reasonably clear that the end users and distributors don't have a major role in facilitating customer feedback, and that is the entire purpose of an Authorized Rep. That's why we put their name on the label. Geesh.

And also, now I'm worried that to clear this NCR I may have to go through all my customers and establish separate agreements with them mandating they provide me notice of any complaints and feedback? Again, that's the point of the Authorized Rep, and what's already in the law.

Anyway, Im just posting to rant a little. but any feedback would be appreciated.

Thanks,

It isn't dumb. It looks to me that in the first place you have not established the contractual agreement with your first AR well. This situation has come to you now because no obligations post the contractual agreement ceasure were addressed. With the new AR, please address this aspect in the contractual agreement.
If you contract with a professional EU AR, all these aspects are well addressed in the AR contractual agreement.
We work with MDSS and I have no affiliation with them.
 
Last edited:

joemar

Involved In Discussions
#5
Well, see, this is my point. I agree that there should be an effective communication system with distributors and customers, but where I'm a bit lost is that this is the entire purpose of the AR. We have a credible AR, and that is their job, by definition.

We do regular customer feedback polls and other communications, but if there was an incident in the EU, I'm pretty sure that both national laws and our existing relationship with our AR are enough to satisfy the standard.

So, what am I supposed to do, establish separate agreements with all the potential customers and customers of distributors (which, yes, the distributors purchase our products, they dont hold them on consignment or something like that, so they are customers) that eliminates the role of the AR? So distributors report incidents to us directly? that doesnt make sense. Otherwise, Im thinking to just provide statements with purchase agreements saying they will provide effective communication on quality, and recognize our AR as the place to direct incidents (though this is required by law anyway, and redundant).
 

Ronen E

Problem Solver
Staff member
Moderator
#6
The purpose of the AR is to have someone "on EU soil" that the authorities can lay their hands on when something goes seriously wrong :) In less dramatic terms the authorities need a name and an address within their jurisdiction. In most benign cases the authorities will communicate directly with the manufacturer, keeping the AR copied.

The AR is not there as an information middleman. The manufacturer should have direct communication with customers.

You need to have arrangements with direct customers for effective flow of information. You don't need to have such direct arrangements with distributors' customers. The requirement doesn't say that you have to have it in a contract; only the challenge would be convincing that the arrangements are and will be effective.
 

somashekar

Staff member
Super Moderator
#7
Well, see, this is my point. I agree that there should be an effective communication system with distributors and customers, but where I'm a bit lost is that this is the entire purpose of the AR. We have a credible AR, and that is their job, by definition.

We do regular customer feedback polls and other communications, but if there was an incident in the EU, I'm pretty sure that both national laws and our existing relationship with our AR are enough to satisfy the standard.

So, what am I supposed to do, establish separate agreements with all the potential customers and customers of distributors (which, yes, the distributors purchase our products, they dont hold them on consignment or something like that, so they are customers) that eliminates the role of the AR? So distributors report incidents to us directly? that doesnt make sense. Otherwise, Im thinking to just provide statements with purchase agreements saying they will provide effective communication on quality, and recognize our AR as the place to direct incidents (though this is required by law anyway, and redundant).
It seems that in the first place your present AR (distributor) does not know the role and responsibility of an AR. This also seems the very reason for your changing the AR.
Now, your device will carry the present AR details, till you make a change. At any future time, your device with the old AR name on it may still be a case for the customer / competent authority to reach out to the AR on the label. At this instant, that AR cannot deny giving reason that the contract would be closed. His obligations upon termination of the AR contract is perhaps not in the agreement text.
So as you close his contract now, you still need to agree upon with him, his role post the contract termination. Perhaps he (the distributor AR) may not even know this.
You need to make him aware and establish linkage suitably such that anyone contacting him are properly handled and directed. Off course, anyone can contact you directly from the label information, however the purpose of AR is diminished here in this case and your NB is surely concerned.
The drawback in your case is that you are out of EU, and so the AR comes into picture. This picture has to be clear under all circumstances... :)
 
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