Repackaging - replacing the IFU when a language change is required (IVDR)

JackyoneDC

Registered
Good morning,

I'm hoping someone can help me - I'm new to The Elsmar Cove and I'm having a bit of a struggle.

The company I currently work for is a manufacturer of IVD products (now legacy devices but transitioning to IVDR Class C) and we want to sell our products in various EU countries. I understand that the IFU in English will not be sufficient for most EU countries, so a translation of the IFU will be done.

We have neutral labelling on the boxes so that the products can be sent to all the EU countries we want to target.

For each production batch, a specific UDI is set. The production batch is usually destined for only one country, so during the packaging process, an IFU is added to the package in only one language.
In the specific case where we receive an order from a country that requires a translated IFU, we would like to replace the IFU in the package with the translated one, but not manufacture a new production batch. We can have a specific procedure for repackaging that would record the IFU change for a particular production batch and the number of kits changed. Is this acceptable, even though the original production included references to an IFU in a language that would now be changed? Could there be a problem with UDIs in this case?

Thanks in advance for your help,

JackyoneDC
 

kenbarlow

Registered
Would you not consider having all relevant translations for the markets your device is intended for, consolidated into one document, to negate having to "re-package" every time?

Not sure how much closer to having eIFUs we are, but hopefully a digital solution is coming soon.
 

Attachments

  • medtech-europe-position-paper-on-eifu-extension-to-all-professional-use-mds.pdf
    312 KB · Views: 84
Top Bottom