Use of CD roms in Labeling of Medical Devices

C

Chris Auditor

#11
The answer is in your own post. Your second bullet point states "information must be set out in the leaflet supplied with one or more devices.". It is the interpretation in Germany that leaflet means paper. The concern is that users will not be able to access an electronic IFU or will not make the effort to do so. There is concern that this will result in increased user error. There are already many reportable incidences caused by failure to follow or read the IFU.

It is worth noting that the 2007 revision of the MDD requires that guidance be developed on this topic. I have seen a draft of this guidance, but it is still not a finalized document. Once this becomes final, it will be feasible to have electronic IFUs, provided that the guidance is adhered to.
 
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B

blewispunk

#12
Hey Chris -

I completely overlooked that statement, but I don't know that I am interpreting it the same way. I agree that leaflet implies paper, but I believe this statement is saying that if you cannot provide the instructions in the packaging with each and every device that it must be supplied in a leaflet supplied with one or more devices. Particularly for software devices I believe having the instructions electronic is as close to getting the instructions "on the device itself". Again, I think this just needs to be done in consideration of the device the instructions are describing and the clinical use of the device.
 
C

Chris Auditor

#13
Your comments make sense. Unfortunately, you don't have to convince me. You need to convince the German competent authority BfARM and the designating authority for German notified bodies ZLG. Good luck!:)
 
S

Slayer_ch

#14
My experience is that up to now they don't want to discuss about this. Our Notified Body told us that for the moment there is no way to include it only in electronic format.
 
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