2021/2226 on Electronic Instructions for Use (IFU) for medical devices Article 22 Packs


With the new introduction of 2021/2226 in January - in the interests of sustainability, it would great if we could move from paper based IFUs within our surgical procedure packs to eIFU QC code and remove the paper IFUs.

The products included in the packs (all Class I, IIa/b) all have products where the manufacturers are displaying IFUs on their website, in addition we are also displaying their IFUs in electric format on our website (we are assembling the packs).

1. The list of products now applicable for eIFU are (a) implantables (b) fixed installed (c) medical devices with built-in visually displays.
- is point c applicable for single use medical devices, with QR code available for scanning?

2. Is a risk assessment still required - or is it enough that the legal manufacturers have done this and implemented an electronic alternative to paper based solution?

Thanks in advance
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