Dear Erik and Andr
é,
The idea that the Importer and Customer should be considered a supplier came up very early with the implementation of the MDR. And it is understandable because of certain consultants and Notified Bodies who were quite confused. During a RAPS meeting one even NB stated that they would audit the Importer and they would have the right to do it unannounced. The reason for this was EN ISO 13485 defining a distributor as a supplier.
Please be careful with general statements and the exact legal requirements.
And certainly distribution company may be supplier. For example the logistic firm you use is a supplier. You may think of other aspects concerning the distribution of products. However the entities Distributors and Importers are precisely defined and those have to fulfill the legal obligations as stated in the MDR.
There were as well other confusion like:
- the Importer must be appointed --> wrong
- The Importer needs to be mandated --> wrong
- Agreements with Importers and Distributors are a must --> wrong
- ...
Hopefully this is now resolved for the ones who have to implement this. If not on September 8, MDSS provides an
online Seminar for its clients (free of charge) concerning Importer. It is open to everyone for a small fee. I will address all the above and certainly questions may be raised. We believe the Importer aspect is fully resolved and is not an issue any longer.
Please let me know whether the above information is helpful.
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Ludger Moeller
President, MDSS GmbH
l.moeller@mdssar.com------------------------------
Original Message:
Sent: 20-Aug-2022 10:13
From: Erik Vollebregt
Subject: Contracts/Agreements with Importers/Distributors
Hi André, I think you're representing a minority viewpoint here. The MDR and IVDR do not see importers as subcontractors or suppliers (they have specific controls for those), but as independent economic operators that have their own responsibilities under the MDR or IVDR. Furthermore, European competent authorities that have issued guidance for distributors and importers (e.g. the Belgian FAGG and the Irish HPRA or even the MDCG in its Q&A about importer and distributor obligations do not touch upon this in their guidance).
I agree completely with you that suppliers and subcontracts should be controlled by quality agreement, but this is not the case for importers and distributors.
You may also note that the MDR and IVDR actually do require agreements between distributors and manufacturers in specific cases (article 16 (1) (a)) and it may be convenient in other cases (e.g. for collection of PMCF data) but it is not required for normal making available of devices in the supply chain (because the article 13 and 14 controls on importers and distributors are already applicable based on the law itself).
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Erik Vollebregt
Partner
Amsterdam
Netherlands
Original Message:
Sent: 20-Aug-2022 08:01
From: André Luiz Cattiste Filho
Subject: Contracts/Agreements with Importers/Distributors
Hi Erik
I have a divergent interpretation regarding this. The Quality Agreements are required for any process the manufacturer outsources. Although there is no direct requirement defined in the MDR, Article 10.9 states that the organization has to have a QMs implemented.
Art.10.9
...Manufacturers of devices, other than investigational devices, shall establish, document, implement, maintain, keep up to date and continually improve a quality management system that shall ensure compliance with this Regulation in the most effective manner and in a manner that is proportionate to the risk class and the type of device....
...The quality management system shall address at least the following aspects:
(d) resource management, including selection and control of suppliers and sub-contractors;...
This implies that the QMS shall address controls over suppliers and subcontractors.
As EN 13485:2016 is a Harmonized standard, the requirements of this standard shall be used a the basis for the QMS required by MDR Art.10.9.
In light of that, clause 4.1.1 and 4.1.5 are applicable, and 4.1.5 shall require a written quality agreememt.
Have all a good day
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André Luiz Cattiste Filho
Moreland GA
United States
Original Message:
Sent: 17-Aug-2022 02:51
From: Erik Vollebregt
Subject: Contracts/Agreements with Importers/Distributors
No, because importers and distributors have their own obligations, see mainly articles 13, 14 and 25 MDR. There is no MDR based obligation for the manufacturer to contract with importers and distributors or for importers to contract with distributors. However, in practice this may be a very good idea. It allows more efficient use of regulatory resources in case the importer and distributors are part of the same corporate group (I wrote an article about this in RAPS Focus in 2019). In the case of independent importers and distributors it would be a good idea for a manufacturer to do this in order to get access to PMCF information, which (see Annex III) may be sourced from the supply chain.
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Erik Vollebregt
Partner
Amsterdam
Netherlands
Original Message:
Sent: 12-Aug-2022 14:18
From: Anonymous Member
Subject: Contracts/Agreements with Importers/Distributors
This message was posted by a user wishing to remain anonymous
Is it a requirement of the EU MDR to have contracts/agreements with Importers and Distributors to make sure obligations are met? If so, please provide a reference if possible.
Thanks!