Extending shelf life - Overlabelling existing products

DrFergal

Starting to get Involved
Good afternoon,

We have a few products in stock (Class I non-sterile devices) which are approaching their expiry date (in 6 months). Since we placed this product on the market, we have successfully extended the shelf-life by an additional 2 years through accelerated and real-time ageing reports. We have written a rationale for the shelf-life extension and re-tested the existing batches through accelerated ageing and they meet the additional 2 years successfully.

The issue we are having is that on the product box (lowest level of packaging) there is a small area with the UDI barcode and the expiry date in a printed format (some products in question have stickers only). We would like to place a new sticker with the same LOT, manufacturing date etc but the new expiry date based on the extended shelf-life. I have found conflicting information around the ability to over-label the existing expiry date and wondered if anyone had any information about whether this will be possible. As a class I device we have no NB to seek approval from so it would be very helpful if someone could offer some advice?

Many thanks in advance
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
You should perform the same testing on real time aging of the product. How you wrote your first paragraph is confusing to me on that topic. I assume this test is identical to the originally approved test for shelf life.

I believe your plan is acceptable. Are you doing this in-house or within the distribution channel?
 

DrFergal

Starting to get Involved
Thanks for the reply Ed. My apologies for the confusion.

1) Our tech file has 5 years shelf life through real time ageing of previous batches. All new batches have a 5 year expiry on them

2) We have some products in stock that were made 2.5 years ago (when we claimed 3 years shelf life) under a single batch (for each size). We accelerated the ageing by an additional 2.5 years to show that they would still meet their requirements at 5 years total. We are writing a report to justify the shelf-life extension of these batches.

The test is identical as it had to meet specific EN standards and we have to prove the EN standards are still met for the new shelf life.

I think we are fine justifying the shelf life extension but my question is if we can over-label the expiry date with the new expiry date. The original expiry would remain underneath (albeit hidden).

We would be doing this in house only from our own stock. Our distributors generally take a few weeks at a time so we won’t need to re-label anything that has left our warehouse.

Do you think a new sticker with the new expiry date covering the old one is acceptable?
 
Last edited:

Aliken

Involved In Discussions
Thanks for the reply Ed. My apologies for the confusion.

1) Our tech file has 5 years shelf life through real time ageing of previous batches. All new batches have a 5 year expiry on them

2) We have some products in stock that were made 2.5 years ago (when we claimed 3 years shelf life) under a single batch (for each size). We accelerated the ageing by an additional 2.5 years to show that they would still meet their requirements at 5 years total. We are writing a report to justify the shelf-life extension of these batches.

The test is identical as it had to meet specific EN standards and we have to prove the EN standards are still met for the new shelf life.

I think we are fine justifying the shelf life extension but my question is if we can over-label the expiry date with the new expiry date. The original expiry would remain underneath (albeit hidden).

We would be doing this in house only from our own stock. Our distributors generally take a few weeks at a time so we won’t need to re-label anything that has left our warehouse.

Do you think a new sticker with the new expiry date covering the old one is acceptable?
The approach sounds OK to me (although such scenarios should be avoided and CAPA may be appropriate). Don't forget to retain a record of the original device UDI.
 
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