Anon,
It highly depends on the product, how the outer box configuration with the device is made, and any impact to the safety and performance of the device. There are quite a few activities which should be reviewed as part of a "repack" which includes reviewing the specific instance, reviewing this against the shipping/transport validation, understanding how and why it happened, risk involved with repacking the device, and defining whether this is acceptable. At a minimum, there should be a non-conformity raised to understand how and why the outer box is damaged. If this something which can happen, maybe there is a work instruction created for review, examination of the product, any inspection, and then the process for repacking. You will not find anything specific to this in the EU MDR regulation, but there are many "in between the lines" contained in Annex I, General Safety and Performance Requirements, to ensure the product packaging is suitable and complete.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Principal Strategy Consultant
NAMSA
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Original Message:
Sent: 16-Feb-2024 01:32
From: Anonymous Member
Subject: Repackaging
This message was posted by a user wishing to remain anonymous
Dear All,
Hope you are doing well!
In Medical Device Class III products, is it allowed to repack the product if the outer box is damaged according to EU MDR? If it is there any specific criteria to repack the product?