ISO 20417:2021, Requirements for e-doc 6.6.5

MDRexpert

Involved In Discussions
#1
Hi Everyone,
The (b) requirements states that the IFU available on the website, the label may include a 2D dimensional code (e.g., QR code). Can someone clarify what this means?

Thanks,
Akanksha
 
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mihzago

Trusted Information Resource
#2
it means that instead of displaying a web address that contains the IFU you can instead display a QR code that has an embedded link, that way I guess you can save space on the label.
 

mihzago

Trusted Information Resource
#4
If the e-IFU is built-in to the device, then the QR code probably is not going to work. Keep in mind, the QR code or other method is an option, not a requirement.

Furthermore, if your product is offered in the EU, then you must consider REGULATION (EU) 2021/2226, which requires that regardless of how to provide access to eIFU, you must also publish the eIFU on your website.
 
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