Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi all,

Does anyone have any experience with providing IFUs on a CD as opposed to paper?  Even though it would be a digital copy, it seems like it would not fall under an eDFU because it is packaged with the device. 

Thanks!

Well, the first consideration would be usability. Who all needs the information included in the IFU, when do they need it​, and will they be able to access it properly? In some cases, a CD is more useful than paper. In other cases a CD could make important warnings inaccessible to a user. Based on risk, sometimes the best answer is a CD and/or a website plus a printed quick guide... Of course it depends on what kind of product you have.

Then there are country-specific rules. If you're distributing in the US, check out the FDA guidance "Acceptable Media for Electronic Product User Manuals". If you're distributing in the EU, look at regulation 207/2012 and/or the MHRA "Guidance on the regulations for electronic instructions for use of medical devices"...

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Anne LeBlanc
Manager, Regulatory Affairs
United States
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Original Message:
Sent: 30-Jan-2019 15:56
From: Anonymous Member
Subject: IFU on CD?

This message was posted by a user wishing to remain anonymous

Hi all,

Does anyone have any experience with providing IFUs on a CD as opposed to paper?  Even though it would be a digital copy, it seems like it would not fall under an eDFU because it is packaged with the device.

Thanks!

Have to agree with Anne whole-heartedly that you have to examine how the CD is going to be used in context of the device, environment, and qualification of the users.  I have used CDs or IFUs loaded on the actual PC in the past, with a short "quick guide" detailing the indications for use, warnings, precautions, and then instructions on how to access the electronic version.  Use some awareness though because some regulators do view CDs and the like as eIFUs even though they are shipped directly with the device.  Anne provided a couple good documents that have good view on how to handle electronic labelling/IFUs.  Just a note also making sure your risk management file and usability information reflects use of an IFU on CD as well.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 31-Jan-2019 20:44
From: Anne LeBlanc
Subject: IFU on CD?

Well, the first consideration would be usability. Who all needs the information included in the IFU, when do they need it​, and will they be able to access it properly? In some cases, a CD is more useful than paper. In other cases a CD could make important warnings inaccessible to a user. Based on risk, sometimes the best answer is a CD and/or a website plus a printed quick guide... Of course it depends on what kind of product you have.

Then there are country-specific rules. If you're distributing in the US, check out the FDA guidance "Acceptable Media for Electronic Product User Manuals". If you're distributing in the EU, look at regulation 207/2012 and/or the MHRA "Guidance on the regulations for electronic instructions for use of medical devices"...

------------------------------
Anne LeBlanc
Manager, Regulatory Affairs
United States

Original Message:
Sent: 30-Jan-2019 15:56
From: Anonymous Member
Subject: IFU on CD?

This message was posted by a user wishing to remain anonymous

Hi all,

Does anyone have any experience with providing IFUs on a CD as opposed to paper?  Even though it would be a digital copy, it seems like it would not fall under an eDFU because it is packaged with the device.

Thanks!