Questions on importer identification have been raised a number of times in this forum, but to keep the answer simple, and to avoid personal interpretations, please refer to Section 4.2.2, 'Traceability provisions', of the 2016 'Blue Guide'.
In this, it explains the fundamental reason for having the importer (that is the entity placing the device on the EU market) identified by device labeling until the point that the device reaches the end user, stating:
"The indication of the manufacturer's, and for imported products also the importer's, name and address on the product is a basic traceability requirement. In case of need, it allows market surveillance authorities to quickly get in contact with the economic operator responsible for the placing of an unsafe or non-compliant product on the Union market."In addition, in Section 4.2.2.2, 'The requirement to indicate name and address for importers', it states:
"As a rule, the identification and the address of importer must be indicated on the product. Only where it is not possible, the identification and address of the importer may be indicated on the packaging and / or in a document accompanying the product. This may be the case when the importer would have to open the packaging to put his name and address. The additional information from the importer shall not hide the information put on the product by the manufacturer."From the first Blue Guide extract above, it is clear that the phrase "
and / or in a document accompanying the product" in the second extract means 'accompanying the product
to the end user', otherwise the fundamental reason for requiring traceability is lost. Having this information, for example, only on the shipping note that accompanies the device from the non-EU manufacturer to the EU importer, which is then discarded or filed by the importer, does not fulfil this requirement.
So to hopefully answer to the rather incomplete initial question, yes, the importer's details must accompany the device throughout the supply chain to the end user, even if the importer is a sister company, or subsidiary, etc., of the manufacturer.
Hope this helps.
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Roger Gray
VP Quality and Regulatory
Donawa Lifescience Ltd
UK Responsible Person services
Christchurch, UK
+44 1425 489208
rgray@donawa.comwww.donawa.com------------------------------
Original Message:
Sent: 10-Mar-2021 04:41
From: Richard Vincins
Subject: MDR Importer vs. Manufacturer
Hello,
There are a couple (or more) threads on this subject as there is differing opinions and interpretation of what means to have importer information on the label or 'accompanying documentation', so there is additional thoughts on this subject. There has also been previous statements how interpretation made of the Manufacturer and Importer are two completely separate entities because the Importer is responsible for placing product on the market in the EU when the manufacturer is located outside the Union. Personally, I have my own thoughts on this topic which I have stated in other threads which may or may not be aligned with others interpretation.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 09-Mar-2021 20:59
From: Camille Thorpe
Subject: MDR Importer vs. Manufacturer
Hello Anon,
I believe the MDR definition of importer is "any natural or legal person established within the Union that places a device from a third country on the Union market", so a non-EU manufacturer could not also be the importer.
Are you considering a situation where a non-EU manufacturer has a sales office or warehouse in the EU?
It may be possible for one entity to cover more than one role (e.g. authorized representative, importer). It is also possible for one entity to delegate responsibilities to another. However, this would depend on the appropriate agreements and controls being in place.
Regards,
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Camille Thorpe, RAC
Toronto, ON
Canada
Original Message:
Sent: 09-Mar-2021 10:29
From: Anonymous Member
Subject: MDR Importer vs. Manufacturer
This message was posted by a user wishing to remain anonymous
How is the requirement to provide the importer's information on the label being addressed when the manufacturer imports the product? Does the title of "manufacturer" cover the importer responsibilities as well when no additional importer is identified or does the company need to identify as the manufacturer and importer separately?