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

prkpr

Registered
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.

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


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

twanmul

Involved In Discussions
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 Our rationale was that there was a greater risk that printed versions are more likely to be out of date and therefore using eIFU only (although the EU Reg 207/2012 doesn't refer to 98/79/EC) reduces that risk.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.
 
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