– Welcome to the Medical Device School. Here is Monir El Azzouzi
from easy medical device.com. And I am again with Erik Vollebregt and we are talking about
economic operators. And today, one question is, is it mandatory for distributors, importers
or authorized representative to have a quality management system? We know that it is
mandatory for manufacturers because it’s many
mentioned also on the MDR, but is it the same for the distributors? Should they have one? Is it mandatory for them if they, don’t have, is it a problem, etc. So Eric, can you help us on that? – Yeah Monir I can. The MDR is quite clear, in the parties that need the quality management system because that’s the only the manufacturer. – Okay. – If you look at article
10, it says the manufacturer needs a quality management system, which covers this bunch of aspects. If you look at the older
economic operators, authorized representative, importer and distributor, it doesn’t say anywhere that they must have a
quality management system. – So should I trust a distributor if they have no quality
management system then? – Probably not, because, because (laughs) what you see in the MDR is that, economic operators get a lot
of procedural responsibilities. And I think where you start to combine procedural responsibilities that are really about something, and you combine it with a party that says, “Ah, quality system, humbug!” I don’t need a quality system, then I think you are probably not dealing with a party that takes it as seriously as they should. Actually, this is also
discussing quite a lot of detail in an interesting document
published by the HPRA, the Irish competent authority, good distribution practices
for Medical Devices. And in that document they also say, well, for the activity of
distribution of medical devices, you do not need a quality system per se. But these things listed in the document, we consider a good distribution practices. This is something that
everybody should do. And then if we look at what these good
distribution practices are, it would really make a lot
of sense for a distributor that wants to be able to control all these activities adequately, to implement , a quality system to the level of the ISO 13485 , 2016. So they can actually also, because that’s what the
quality system is about. I mean, it’s about controlling and demonstrating that you
control these procedures and what you do not want
as as a manufacturer, or as an overseeing competent authority. You said you don’t have a
distributor or an importer, that’s as to I have no idea
what happens in my warehouse. – Okay. so it means that
it’s not mandatory by MGR. It is a good practices for distribution. But if I have a distributor that says, yes, I have a
quality management system, but I didn’t certify it. I have my procedures, I
have my (mumbles) manual. I have some procedures to show, to detect etc. But it’s
not something certified. Should I still think that
it’s a good distributor? – Well theoretically yes. But then I would want to do all that, on the distributors procedures and go look, that because in the MDR, there are quite clear criteria for what the distributor
must do for example. And what I would like to see then as a manufacturer for a distributor, I would like to see that at least they implement these things in a way that I can be confident about it. Because even though it
is their responsibility and not mine as manufacturer, the situation will always
be that if there’s a problem with the products because of something that
happens at the distributor, it will be the name of the
manufacturer in the news and not out of the distributors. There is your interest as
manufacturer to do these. And what you see in practice is all sorts of distribution
agreements of manufacturers, We’ll address a little of
quality type obligations. – Yeah. And I think just for the audience to understand when we are talking about the
quality management System , we are not just talking
about a bunch of procedures that are in a binder letter, we just say we are certifying our company because we have those documents. It’s really a culture So it’s people that have to use that to be compliant and to
provide a compliant products on the market, but also it’s a warranty for manufacturers because if there is an
issue on the market, they know that there
is a procedure existing to address this issue, to contact the right or
competent authority etc. That is something that is helping you, that they have also a
process for managing problems like Kappa system etc. That it means that they can help you to solve the problem, instead of having a company
that has no procedure or has a weak procedure just to have some. But at the end they are not
choosing them correctly. So I think it’s really important
for people to understand that this is not to just have some paper, but really to have a really understanding of those systems. – Yeah because procedure
without procedural awareness and procedural application
is still nothing. – Exactly. – And for example, I mean distributors have the obligations to
safeguard storage conditions. Now let’s say there is an incident with a Medical Device at the hospital, because it was compromised during storage. What will happen? there’s
a vigilance report. Route goal says, okay,
device was compromised when its arrived at the hospital, but this was not discovered. And they go heap then they are angry with the hospital because the hospital had
acceptance procedures, but then they go to the
distributor and they say, okay, distributor, how can this happen? And the distributor says, well, we have, yeah, here’s
our binder with procedures. And then of course the next
question is going to be yes, and how do you apply it? How
do you manage these procedures? And if they stay well, yeah,
we just have these papers. Yeah, of course then this is not something that you’re going to get away with. And then a competent authority can say, okay, you’re clearly not
fit to be a distributor. We close down your company. – So careful, Yeah. I think it’s an important
message that even if it’s not an obligation to have a quality management system, it’s really a warranty, that these distributors will be serious and can really help you to
distribute core products on the market. – I would add that even if you
don’t have a quality system, then you need to have a way to
demonstrate quality thinking. – Exactly. Yeah. So it’s why even the
manufacturers have maybe to audit the distributor and project that they are
doing the job correctly through their procedures. Okay, So great. So thank you Erik. Don’t forget also for people
to go to the show notes. I will try to put also some documents for you to
download or some articles to read and yeah, and don’t forget also to put a review on the podcast. It’s really important between, good for people, and if you know somebody
that is really interested to understand more
about economic operators or MDR IDR, so don’t get all
sort of shove eggs everyone Okay, Eric, so thank you for your help and I wish you a nice day. – El Azzouzi Monir bye bye (soft music)

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