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,

 
Elsmar Forum Sponsor
A

Access2hc

#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
Admin
#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
Admin
#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... :)
 
Thread starter Similar threads Forum Replies Date
G Not accepting a non conformity during an audit General Auditing Discussions 11
G Dealing with non conformity caused by Supplier Components detected in the production line IATF 16949 - Automotive Quality Systems Standard 14
S Can we provide training plan as corrective action for IATF 16949 Non conformity? IATF 16949 - Automotive Quality Systems Standard 9
qualprod Non conformity, do nothing? Employee experiencing "hard times" ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
D Root Cause on Non-Conformity Against Quality Manual Problem Solving, Root Cause Fault and Failure Analysis 9
M Auditing a Contractor in EMS and Non Conformity Report General Auditing Discussions 1
A IATF 16949 - Non-conformity on 5.1.1.2 Process effectiveness and efficiency IATF 16949 - Automotive Quality Systems Standard 5
B IATF 16949: Definition Major/Minor Non-conformity IATF 16949 - Automotive Quality Systems Standard 6
E Non Conformity due to Outsourced Internal Audit Error ISO 14001:2015 Specific Discussions 2
R Non-Conformity Report from Notified Body - MEDDEV Guide is not Legally Binding EU Medical Device Regulations 16
B A question of Non-conformity specifics - AQAP2120 (The MOD's equivalent to ISO9001) General Auditing Discussions 1
Q Non Conformity of Support Processes - Need another NC form? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Q Non Conformity in Audit: Missing Deputy Rule ISO 13485:2016 - Medical Device Quality Management Systems 10
S Internal Audit - Non conformity not easily fixable (Sales and Contracts) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 30
L Non Conformity (Nonconformance) Report & Preventive Action Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
S Some departments don't have Quality Objectives - Non Conformity? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 68
S HR Manager refusing to create Quality Objectives - Is this a Non-Conformity? Quality Manager and Management Related Issues 11
H Product Non-Conformity and Document Change Request Forms - Corrective Action needed? Nonconformance and Corrective Action 16
A Declaration of Conformity for non-CE Mark products CE Marking (Conformité Européene) / CB Scheme 2
Q How do you define repeated non conformity (aka Recurrence)? Nonconformance and Corrective Action 24
T A confusing Non-conformity - No defined QMS processes intended for 'Management' ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
A Non-EU countries who use your EC Certificate & Declaration of Conformity Other Medical Device Related Standards 3
eternal_atlas Identification of ISO 9001 Clause to a specific Non-Conformity General Auditing Discussions 7
C Show cause letter given as a result of a minor non-conformity raised by CB Quality Manager and Management Related Issues 6
L Completed Non-conformity report examples needed! ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
T Non-conformity - Not performing Supplier Development on one specific supplier IATF 16949 - Automotive Quality Systems Standard 25
A Communicating to our employees: consequences to customer of non-conformity IATF 16949 - Automotive Quality Systems Standard 3
D TS 16949: 2002 section 7.6.1 - MSA non conformity at registration audit IATF 16949 - Automotive Quality Systems Standard 2
K Major Non-Conformity During Initial TS16949 Audit Nonconformance and Corrective Action 2
M Record Falsification - What clause to raise a non-conformity? Records and Data - Quality, Legal and Other Evidence 20
Q API Spec Q1 9th Ed 4.4.2 Non-conformance Oil and Gas Industry Standards and Regulations 8
T Do I need to add non-product related service providers to my ASL? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
J ISO 13485- 8.3.1 Non-conforming material high volume ISO 13485:2016 - Medical Device Quality Management Systems 4
F MSA for non-contact CMM - ISO10360 Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 0
M Using a Non Certified vendor Supplier Quality Assurance and other Supplier Issues 5
somashekar Justification for Non-applicable clause at Stage 2, in clause 4. ISO 13485:2016 - Medical Device Quality Management Systems 11
Z Swiss Authorized representative & non-medical device regulations Other Medical Device Regulations World-Wide 0
R Lead auditor scenario (Need help) is this non conforming to ISO13485 Manufacturing and Related Processes 2
D Help Me. Non conformitty in External Audit IATF 16949 - Automotive Quality Systems Standard 13
S Electronic Signatures - Non-Conformance - ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 30
S Do you follow your QMS for non-device software features? Medical Information Technology, Medical Software and Health Informatics 4
J Can we register non-device clinical decision support software under draft guidance? Other US Medical Device Regulations 5
D IATF 16949 SI 10, External non-accredited lab IATF 16949 - Automotive Quality Systems Standard 4
M Selling non-CE marked devices for evaluation EU Medical Device Regulations 4
T Non API products need to comply to API Q1? Oil and Gas Industry Standards and Regulations 3
L "Shelf-Life" Class I Non-Sterile Products Expiration Date? CE Marking (Conformité Européene) / CB Scheme 3
B Process / Procedure - Radiographic (X-Ray) Non-Film Document Control Systems, Procedures, Forms and Templates 0
N How to find column number for the last non-empty column? Using Minitab Software 0
A Need to calculate tolerance Intervals with a set of non-normal data and 3-Parameter Weibull distribution Using Minitab Software 0
3 Non-conformance Register vs Corrective Action Register ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13

Similar threads

Top Bottom