Should eIFU link per ISO 15223-1:2016 be added to labels out of scope of Reg 207/2012?

[prkpr]

Hi All,

We add "eIFU" link in addition to the "open book" symbol to indicate that there is also an electronic IFU on the website. This is per ISO 15223-1:2016. However, we also supply paper IFUs since our medical devices are not in scope of EU Reg. No. 207/2012.



Is this an acceptable interpretation? I would love to know from others' experiences with regulators.

 

[twanmul]

We use an eIFU only for our IVD's which are assessed using ISO 15223-1. Our devices are for professional use only, so is a good reason for this to be made available in this format. Our rationale was that there was a greater risk that printed versions are more likely to be out of date and therefore using eIFU only (although the EU Reg 207/2012 doesn't refer to 98/79/EC) reduces that risk. Our NB seemed happy/didn't comment to the contrary with this.