Dear Max,
thank you for the clarification concerning the ISO 13485.
Indeed in the ISO definition of a supplier the distributor is mentioned whereas the MDR does not state this.
We strongly recommend and analyze the role and the specifics concerning the MDR. There are two distinguished aspects and those are black and white. Certainly there may be a lot of grey with different solutions.
However, in order to clarify the requirements on the different actors we have to look at the following:
1. The customer:
A manufacturer markets his products to a customer who in turn then distributes the products. The product is ready to be sold as is and contains all the information needed to be utilized. Nicely packaged and the environmental condition on how to store and transport the product are on the outside of the box.
The customer is a Distributor and under the MDR - an Economic Operator (EO) on its own. He Makes the Product Available! In regards to the MDR no special agreements are needed since the MDR clarifies what the Distributor must do. There may be difficulties to add this Distributor who is customer to the supplier list. Your Marketing/Sales may have a problem if the regulatory department first wants to qualify a customer!!! Sounds somewhat odd or?? It is not required and fortunatly it is not requested any longer by the NBs. The role of the EO has been finally understood (You still may have an auditor with their own ideas but overall the NBs have backed off. Indeed they started with requesting that the manufacturer must appoint the an Importer/distributor similar to the EC REP, which was significantly wrong). The Authorities here in the EU take care of the Importer and the Distributors as they have a very specific role as Economic Operators.
The role is that they should look at the manufacturer as the supplier and they are ask to scrutinize the supplied products and with that the manufacturer. 2. A distributor as service provider (please note the d instead of D)
The manufacturer hires a firm and the firm distributes the products on behalf of the manufacturer. For example a third party logistic provider. That entity is a supplier to the manufacturer and certainly should have been evaluated under your quality system as your supplier.
Please let me know whether this clarification is helpful.
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Ludger Moeller
President
MDSS GmbH
l.moeller@mdssar.com------------------------------
Original Message:
Sent: 26-Jun-2022 02:29
From: Max Trebilcock
Subject: EU Distributors Agreement for EU MDR
This is where it's important to look at the QA aspects of the manufacturer and their third parties, plus the rules of the territory.
MDR itself doesn't require a distributor agreement, however the manufacturers ISO 13485 should have a vendor qualification SOP which links to a contract and technical agreement, which the manufacturers NB would expect to see in audit.
additionally some EU/EEA countries require a distributor to register with their national authority and undertake responsibilities, in some bases these responsibilities overlay or replicate areas of EU MDR.
Both notified bodies and competent authorities would expect to see agreements in place based on the above.
In summary look at the local requirements and QMS requirements as well as MDR.
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Max Trebilcock
UK Responsible Person | RAQ Specialist
Vega Healthcare Solutions
London
United Kingdom
Original Message:
Sent: 24-Jun-2022 12:04
From: Bedwuine Senatus
Subject: EU Distributors Agreement for EU MDR
Hello,
Does the EU distributors agreement need to mention ISO 13485 on it . Also, Can we just ask the distributors to comply with EU MDR Chapter III article 25... when we draft the agreement.
Is there any other reference that i need to add in agreement in order to EU MDR...
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Bedwuine Senatus
QA/RA Director
Springfield NJ
United States
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