I agree with Richard that this export-import regulatory issue sounds a bit strange and counterproductive, but with laws, regulations, and guidelines you never know.....
A quick look in the Blue Guide indeed reveals what Richard states: Note (135) - For the purposes of this Guide, imports are products manufactured in third countries and placed on the Union market. Products manufactured in one Member State and placed on the market in another Member State do not constitute an 'import' as the operation takes place within the Union internal market.
it does not say explicitly that this is true for products sold from an EU Manufacturer to a third country and then sold back into an EU Member State; it also does not explicitly prohibits this. No import, no Importer.
An issue with regard to traceability may remain. Economic Operators have to ensure traceability between them. With a third-country entity in between them, not eligible for EU Economic Operator obligations, the chain of traceability may be broken. But this is also the case for a third-country Manufacturer who sells their devices first to an entity outside the Union, who then exports them to an Importer in the Union. I presume there are many more examples the MDR or the Blue Guide does not have a clear answer.
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Peter Reijntjes
Principal Consultant Regulatory & Quality Affairs | Head of Training
Arnhem
Netherlands
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Original Message:
Sent: 21-Mar-2023 09:57
From: Maria Oplopoiou
Subject: Reimport from Switzerland to EU
I would like to thank you all,
it is always extremely helpful, especially in such matters, to share our views and trigger further discussions.
Best,
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Maria Oplopoiou
RA/QA specialist
Frauenfeld
Switzerland
Original Message:
Sent: 21-Mar-2023 09:48
From: Anne LeBlanc
Subject: Reimport from Switzerland to EU
True, from the practical perspective, assuming the manufacturer had intended to place the product on the Union market, there is not much value in the sub-distributor's adding their information to the labeling. The manufacturer's information already on the label should be quite sufficient. (It would make more sense for the sub-distributor to think like an importer if the manufacturer had labeled the product for the Swiss market only.)
Thank you, Richard and Christoph. While a competent authority could always hold you to the letter of the law, it is sometimes more sensible to follow the spirit of the regulations, and not take on excessively burdensome obligations.
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Anne LeBlanc
United States
Original Message:
Sent: 20-Mar-2023 10:37
From: Christoph Kiesselbach
Subject: Reimport from Switzerland to EU
Hello Maria,
with the caveat that I am not a lawyer and this might be more a legal than regulatory question, I would agree with Richard here. If the device is CE-marked by a EU manufacturer and has not been changed, I think the "re-import" is not an import in the regulatory sense of the MDR (in contrast to e.g. customs). That said I would also agree that there still is a residual risk with respect to the interpretation here.
Best regards
Christoph
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Christoph Kiesselbach
Reutlingen
Germany
Original Message:
Sent: 17-Mar-2023 06:13
From: Maria Oplopoiou
Subject: Reimport from Switzerland to EU
Hello everyone,
A rather complicated question
If an EU manufacturer imports a medical device to Switzerland to a CH distributor and then they reimport the device to sub distributors in the EU, would there be something that shall be taken into consideration from the manufacturer or distributor side? To my view, the fact that the distributor reimports the devices into the EU market, might be the culprit of additional requirements.
Could you please offer your view on the matter?
Thank you and have a nice day!
Best regards,
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Dr. Maria Oplopoiou
RA/QA specialist
Switzerland
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