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Instructions for use for Class I devices under MDR

JP12345

Starting to get Involved
#1
Hello!

As we are working our way through the GSPR’s for our class I devices I have a couple of questions we are struggling to find the answers to and I wondering if anybody can help or share their way of addressing the following:

  1. Where a class I device doesn’t have any instructions for use as it can be used safely without instructions (ref GSPR 23.1(d)) how can we satisfy GSPR 14.7 which requires disposal of waste procedures to be added to the instructions for use? Does this mean that all devices must have an instructions for use?
  2. Where instructions for use are deemed necessary for our class I devices, is it acceptable to point to the waste disposal instructions on the MSDS for that product in the instructions for use? How are others dealing with this?
Thank you!
 
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Loekje

Starting to get Involved
#2
Hi JP,

The most formal answer I have heard is: "If your product needs instructions how to dispose of it after usage then it cannot be safely used without instructions. I.E. 23.1.(d) is not valid then."

We have struggled with something similar, as it is not the IFU per se that is bothersome, but rather the requirement to have it available in every local language where you want to put it on the market. Translation costs are sometimes prohibitive.
So 23.1(d) will free you of that obligation as well. (Annex II, 2 second dash IIRR)

We make medical electrical devices, so putting the mandatory crossed wheely bin logo on the label is usually enough to comply to 14.7. Maybe that will work for you as well?
To circumvent the IFU requirement we too sometimes follow "the datasheet route" in which we do not give instructions for cleaning but rather state that the material is damp cloth and mild detergent resistant...

I guess it boils down to how important the waste disposal of your product is.

My 2 cents worth.
Regards,
Loek
 
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