Most regulatory authorities would expect the company to stop selling/distributing the product until 1) the labelling is changed reflecting correct expiration dating or 2) testing can be performed supporting the expiration date. There would also be an expectation of a recall or market correction notifying customers the time period up to the stated expiration date may not be valid. Just as a note, when validating the expiration date, shelf life, or use of device, make sure to go beyond a bit from the actual time frame stated on the labelling.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 14-Feb-2020 03:11
From: Peter Reijntjes
Subject: IVD Expiration Date
Dear anonymous,
interpreting your case as safety related, MEDDEV 2.12-1 rev 8 on Vigilance states that Field Safety Corrective Actions should be issued to the Competent Authorities of all countries affected at the same time and also to the National Competent Authority responsible for the manufacturer or authorized representative.
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Peter Reijntjes
Principal Consultant Regulatory & Quality Affairs
Arnhem
Netherlands
Original Message:
Sent: 12-Feb-2020 19:36
From: Anonymous Member
Subject: IVD Expiration Date
This message was posted by a user wishing to remain anonymous
If an IVD expiration date is claimed at x months and a much lower number of months was validated/approved and the product is on the market, does the government of the country the product is sold in need to be notified or just recalled in accordance with the QMS and customers notified?