Help with ISO 13485 Clause 8.3 "Rework" as applicable to Medical Device Servicing

[Marcelo Antunes]

"in ISO 9001 - NOTE 1 Repair includes remedial action taken on a previously conforming product to restore it for use, for example as part of maintenance. "

Does this definition apply to ISO13485?

It does.

However, the main problem here is that the rework requirement from ISO 13485 comes from 21 CFR 820, but there the meaning of rework is different from ISO 13485 - ISO 9001 - as I said before,the original idea of this requirement is based on the fact that rework is only pre-market.

[Vlcekad]

Dear Collegues,

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!