Re: Help with ISO 13485 Clause 8.3 "Rework" as applicable to Medical Device Servicing
I hope this post woul follow the topic.
We have sold EU class III device to Korea, but the distirbutor is unhappy with the expiration of the product. We have still a large quantity of the same lot on the store packed in primary packaging and steripack.
We made stability testing and realized, we can safely extend expiration by one year.
In case of products on the stock (technically unfinished) we want to place a label on the steripack saying that the expiration has been extended. We dont want to take off the label on primary packaging (it shows expiration date) because we would brake the steriliy of primary package.
In case of finished and sold products, however, I think we do not have any tool to extend the existing exspiration.
What does your experience says?
Thank you very much!