Some general principles to consider when determining whether eIFU is appropriate or not.
1) Who is the user and what is then environment it's being used in?
2) What is the associated risk?
3) Many times with larger shipments of the same product, the expectation is that you supply one hard copy and then rely on the eIFU.?
4) What is the mechanism for accessing the eIFU? On the device itself? On a separate platform? WIll the link stay constant and not cause lack of access if IT shifts storage location?
5) Is it viable to have a paper set up sheet with key cautions, warning and fail safes and then the general use instructions are accessible electronically?
6) Localization/translation implications need to be considered?
So like with all regulations, the answer always is, it depends.
Most of the regulators are considering eIFU but bottom line in your Risk Management Files and your design history files you need to document your rationale and you need to check each countries specific regulations on how to handle. Since many countries require submission packages that include your labeling, that is where you would also identify that your utilizing eIFU and your rationale. Suggest that you not ask if it's not defined, but you document why it's logical and appropriate. Many times when you try to do that, you learn that it's not.
Some additional suggestions - many of the SDO's have developed white papers and guidance documents on the rationale. For example, NEMA developed a document that is not just for medical but addresses key requirements for electro-mechanical devices. Worth a read.
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Elisabeth George
Head of Global Regulations & Standards
Ft Lauderdale FL
United States
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Original Message:
Sent: 24-Mar-2022 13:30
From: Anonymous Member
Subject: EIFU
This message was posted by a user wishing to remain anonymous
Hoping to glean some information regarding the current global acceptance of EIFU's. I'm aware that the US, Canada and EU accept EIFU for particular devices (seems primarily those whose end users are medical professionals). Is there a database or method to simplify the search for this information? Are more countries than not accepting EIFU's as a general trend? For a mid size medical device company would you consider it worth the investment to transition to EIFU's?
Any help is greatly appreciated!