FDA vs (EU) 2021/2226 Electronic Instructions for Use (eIFUs)

yyoossssii

Starting to get Involved
#1
Dear All,

Reading the new European Parliament regarding electronic instructions for use of medical devices 2021/2226 I was wondering what are now the differences between European and US (FDA) requirements about User Manual available only on the website of the manufacturer.

We have Class I and Class II devices and we want to add a QR with a link to updated user manual without any paper version.

Do we need to notify our notified body (for europe)? Issure a letter to file (for US)?
Thanks
 
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pziemlewicz

Involved In Discussions
#2
This is a labeling change. FDA guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device covers this.
https://www.fda.gov/media/99812/download

Switching to eIFU becomes a question of risk (see section E). The question your organization must answer and document is: Does a risk-based assessment identify any new risks or significantly modified existing risks? If yes, 510(k). If no, letter to file. Web downtime would allow for manual not to be available; can that cause harm?
 
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