Dear Anon,
what we have heard from the approach of some notified bodies until now, is that this approach is not suitable (under MDR, no experience under IVDR).
That is, if this information is the importer information as identified in Art. 13.3 of 2017/746 IVDR.
Their approach seems to be that the importer information should accompany the device up-and-until the user. On the shipping box, or packaging documentation or even on the bill is not "on the device or on its packaging or in a document accompanying the device".
Note however that the approaches of the notified bodies are not aligned on many requirements of the MDR and IVDR.
Also some months ago a similar discussion was on this forum, with various interpretations.
Still room to maneuver!
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Peter Reijntjes
Principal Consultant Regulatory & Quality Affairs | Head of Training
Arnhem
Netherlands
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Original Message:
Sent: 18-Mar-2021 21:08
From: Anonymous Member
Subject: EU - Shipping Case Labels and Over labels
This message was posted by a user wishing to remain anonymous
Can an over label (sticker with Initial Importer information) be placed on top of a shipping case label that is designed to be compliant with CLP and REACH regulations? The sticker with the Initial Importer information would be placed in a blank space (not covering anything) on the Case label that contains the language of the target market. This would be for an IVDR compliant product.