In the EU, Commission Implementing Regulation (EU) 2021/2226 allows eIFU for specified categories of devices, generally those intended for professional users, and sets conditions: the label has to tell users how to access the eIFU, and a paper copy has to be available on request. A proposed targeted revision of the MDR and IVDR would expand where eIFU can be used, but it has not been adopted. US requirements are separate and depend on the device.
Why it matters for labeling
An IFU is among the most frequently revised labeling documents, and with eIFU there can be a printed and an electronic version of the same content, often varying by device and market. Both have to match the approved source, in every language, and the label has to carry a working access link.
Common mistakes
- Electronic and printed versions out of step
- An access address on the label that doesn't work or points to the wrong version
- Translated versions not updated along with the master
- Assuming eIFU is allowed for a device without checking the conditions in the regulation
Sources
Related reading
GUIDE
Medical Device Labeling Requirements: FDA, EU MDR, UDI, and IFU Explained
EU MDR, FDA, UDI, IFU, and ISO 15223-1 requirements for medical device labels — what teams need to verify before every release.
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ARTICLE
The IFU Error That Started With One Character — And Ended With a Recall
A routine IFU revision, compared against the wrong baseline, missed a single character. Why delta reviews miss the changes that matter most.
Read the article →