Dear All,
This is a great discussion.
We will discuss Article 16 during EURO Convergence under the topic Economic Operator. Eric, the author of the Focus article and I will in particular address this topic and should be subject to the panel discussion.
Therefore, I am looking forward to your feedback in order to get the latest interpretation of this topic covered.
Article 16 may be approached with the MDD history in mind in order to recognize the purpose of this regulation. This may help also to find other solution.
- OEM – PLM aspects
This was well established with the MDD but is not liked by the authorities and significant hurdles have been put in place. Article 16 exactly covers this.
- If someone puts his name on the product then he is the Manufacturer. Please be mindful on the definition of the manufacturer. The manufacturer does not need to design or produce the product. All of it can be outsourced.
"1. A distributor, importer or other natural or legal person shall assume the obligations incumbent on manufacturers if it does any of the following:
(a) makes available on the market a device under its name, registered trade name or registered trade mark"
The OEM and PLM is therefore still possible but it is made clear that the PLM is the manufacturer. May be that was not always understood with the MDD.
In order to avoid becoming the manufacturer a solid solution is provided:
- A solution, which is being done in the industry already today! The manufacturer is identified (with the symbol) and distributor brand is shown on the front. The addition to the MDD is that this must be fixed in an agreement (does not have to be in writing but I would recommend that).
"except in cases where a distributor or importer enters into an agreement with a manufacturer whereby the manufacturer is identified as such on the label and is responsible for meeting the requirements placed on manufacturers in this Regulation;"
I believe Article 16.1 (b) and (c) are self-explanatory. If a distributor, importer or for that matter anone change the product then he is the manufacturer. EXCEPT FOR repackaging and/or translation!
- Changes of packaging and providing translations independently performed by the manufacturer
Under the MDD in particular the translation was viewed as well a significant change and Manufacturers restricted the market with the help of notified bodies (NB rightly so considered a translation critical). However, Manufacturer indeed tried to control the EU market establishing different pricing in the different EU member states with the translations (regulatory most of the time was not even aware of that - ask your sales!). This is a fundamental issue in Europe and the Commission is very vigilant of the free market. Already under the MDD a distributor won a case against his supplier, the manufacture to translate and to distribute the product in other markets within the EU. However, the ruling was stating that he should be certified for these activities.
- This is what is reflected in the MDR and the Importer or Distributor must get these activities under control. One aspect I learned here is that this is not dependent on the risk class. Interesting !
Now, what happens if a manufacturer and a distributor agree that the distributor will perform the translation and repackaging on behalf of the manufacturer?
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Ludger Moeller
President, MDSS GmbH
l.moeller@mdssar.com------------------------------
Original Message:
Sent: 30-Sep-2020 07:37
From: Lee Leichter
Subject: Distributors' QMS certified by NB according to EU MDR
Dear Tina,
Article 16 does require that in certain instances that obligations of manufacturers apply to importers and distributors. However these are limited to three conditional situations.
The first is where the importer or distributor places the product on the market a device under its name, registered trade name or registered trade mark, and even then is does not apply if the distributor or importer enters into an agreement with a manufacturer
whereby the manufacturer is identified as such on the label and is responsible for meeting the requirements placed on manufacturers .
I read this to say that if the actual manufacturer is identified on the label as the manufacturer, even if the distributors name is on the device, and there are agreements that clearly state the the manufacturer is responsible for all manufacturing requirements, then the importer or distributor does not assume any of these responsibilities, including the requirement for a QMS certified by a NB.
The other two condition are obvious and only apply when the device is modified or the intended use is changed.
I believe the article does state the QMS requirements apply to "distributors performing certain activities" however, by not mentioning these activities it could be misleading in seeming to imply that this requirement to have a QMS certified by a NB applied to all distributors and importers.
Lee
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Lee Leichter RAC, MBA
President
P/L Biomedical
Fort Myers FL
United States
Original Message:
Sent: 29-Sep-2020 05:54
From: Tiina Tyni
Subject: Distributors' QMS certified by NB according to EU MDR
Hi,
it was said in article MDR, IVDR, and compliance: A guide for distributors published in RAPS Regulatory Focus yesterday that distributors performing certain activities are obligated to implement a QMS that has been certified by a notified body, as outlined in Article 16 of the MDR.
I cannot find this when I try to look it up in Article 16. Am I missing something...?
Best regards,
Tiina Tyni
RA Consultant