IFU physical copy as a part of product package


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.


Involved In Discussions
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.


Trusted Information Resource
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
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