No, I believe it means the outside package must have the EO symbol on it or an indicator that the device inside is provided sterile. ISO 15223-1 includes the EO sterilization symbol. The importer just checks the outside of the box.
Kind regards,
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Alyssa Thomas RAC
Principal Consultant
Beaverton OR
United States
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Original Message:
Sent: 02-Feb-2021 12:27
From: Anonymous Member
Subject: Importer - verify device is labelled in accordance with MDR. Sterile indicator
This message was posted by a user wishing to remain anonymous
Per the MDR one of the requirements for labeling:
if the device is supplied sterile, an indication of its sterile state
Does this mean for example an eo indicator (label that turns color when exposed to eo) has to be confirmed when importing?
How does importer check for this without opening product if indicator is only on inside pouch; Shelf box has a tamper proof label