In the EU, the requirements are in Annex I, Chapter III of the MDR, and the IFU has to be provided in the official languages of the Member States where the device is sold. In the US, devices must carry adequate directions for use under 21 CFR Part 801. Some devices can provide the IFU electronically instead of on paper (see eIFU).
Why it matters for labeling
An IFU is among the most frequently revised labeling documents, and errors in it can affect patient safety directly: a missing step, an incorrect setting, or a warning that dropped out of one language version. Each revision has to be verified in full against the approved master, not just in the section that changed.
Common mistakes
- A revision checked only where the change was made
- Language versions that are updated at different times
- An outdated IFU packed with a new device version
- Symbols in the IFU that aren't explained
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.
Read the guide →
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 →