IFU physical copy as a part of product package

[appivj]

Hi,
For EU MDD/MDR do we need to have IFU physical copy as a part of product package (product is a system which has multiple component packed together) or IFU can be sent as a separate package?

This question comes from multiple language requirement of IFU in EU and other markets of APAC.

 

[DanMann]

In theory, yes they can be sent separately - in fact, no IFU need be sent at all as long as you have an eIFU available - but you would need to risk assess someone using the device without receiving the IFU, which may lead to expansion of your usability engineering work.

 

[dgrainger]

By "system" do you mean Article 12 in MDD/ Article 22 in MDR? In which case both require information to "accompany" the system. Depending on the device type, you can utilize e-IFU regulation