- 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 Erik, 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 other
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 say.
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 have a
distributor or an importer,
that says I have no idea
what happens in my warehouse.
- Okay. so it means that
it's not mandatory by MDR.
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 an audit,
on the distributors procedures
and go look, that because under 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 that of the distributors.
There is your interest as
manufacturer to do these.
And what you see in practice
is also that distribution
agreements of manufacturers,
Will address a lot 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 that,
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 guarantee
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 CAPA 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 using 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.
Root causes says, okay,
device was compromised
when its arrived at the hospital,
but this was not discovered.
And they go up
then they are angry with the hospital
because the hospital had
bad 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 guarantee,
that these distributors is really serious
and can really help you to
distribute correct 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 to check 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 it's really,
good for people,
and if you know somebody
that is really interested
to understand more
about economic operators
or MDR IVDR, so don't hesitate
to share episode with them
Okay, Erik, so thank you for your help
and I wish you a nice day.
- Thank you Monir bye bye
(soft music)
