Does posting your IFU on your website constitute elabelling?

[ElmerF]

Hi All,

Just wondering if anyone can clarify. We provide paper IFUs with our product but would like to provide the option of also posting on our website for ease of access. Does posting your IFU on your website constitute elabelling?

If not, is it sufficient to use the change control system to ensure that the correct versions of the IFUs are available of the website. Are there additional controls required. Would this require notification to NB and FDA?

Thanks for your help.

Best regards,

ElmerF

 

[pkost]

in the EU, elabelling only applies when the IFU is not included with the product. Provided you keep the IFU with the product, you can include the IFU on your website without any issues - there is no need to notify your notified body

It is certainly advisable to have this as a controlled version!

I can't comment on the FDA