Product Labeling

Mike Towers

Involved In Discussions
Hello everyone,

We sell a kit that is inside a sealed bag, on that bag the IFU of the product is printed, so each product has its own IFU, then we pack 75 of them in a box and this is the way we sell to our customers . .

Now we want to sell one of the components of that kit separately, as another product, so we would seal it in a smaller bag, and then pack 500 units in each box to sell to our customers. The problem is that we cannot print the IFU on each bag, because the size of the text would be too small to read. What could we do?

Could we insert a single piece of paper with the IFU for use for the 500 products in each box? Or should each product have its own instructions for use?

Thank you very much, I look forward to your comments.
 

kenbarlow

Registered
As its Class IIa and as legal manufacturer, I would recommend you doing a risk assessment on the following:
Does it pose a safety risk to medical professionals, to supply your product/kit without enclosing paper/label based Instructions for Use?

Despite having an IFU available, under MDR Annex I, Chapter III, 23.1(d) if you carry out a risk assessment and your findings are that these is not safety risk to medical professionals using your product, you need not supply a paper based IFU at all.

MDR Annex I, Chapter III, 23.1(d) "Instructions for use shall be provided together with devices. By way of exception, instructions for use shall not be required for Class I and IIa devices if such devices can be used safety without any such instructions and unless otherwise provided for elsewhere in this section".
 
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Mike Towers

Involved In Discussions
Is the kit and the single device both used in a clinical setting, so that the whole box is used by the same person/team?
Sometimes the box is for the same customer, that is, the 500, in others it is sold to a distributor who supplies it to its customers in smaller quantities.
 

Mike Towers

Involved In Discussions
As its Class IIa and as legal manufacturer, I would recommend you doing a risk assessment on the following:
Does it pose a safety risk to medical professionals, to supply your product/kit without enclosing paper/label based Instructions for Use?

Despite having an IFU available, under MDR Annex I, Chapter III, 23.1(d) if you carry out a risk assessment and your findings are that these is not safety risk to medical professionals using your product, you need not supply a paper based IFU at all.

MDR Annex I, Chapter III, 23.1(d) "Instructions for use shall be provided together with devices. By way of exception, instructions for use shall not be required for Class I and IIa devices if such devices can be used safety without any such instructions and unless otherwise provided for elsewhere in this section".

Thanks for the answer, my question was more about whether it is necessary for each device to carry the IFU or if there is the possibility of having one for all devices.
Would it be possible if there is a single one for all devices?
 

kenbarlow

Registered
Thanks for the answer, my question was more about whether it is necessary for each device to carry the IFU or if there is the possibility of having one for all devices.
Would it be possible if there is a single one for all devices?

Firstly, you should consider if the product needs an IFU at all, hence my previous post. Just because you already have produced an IFU does not mean you need to supply a paper/label copy - if it does not pose a safety risk to the medical professional using it and its not class IIb or III.

Secondly, if an IFU is needed and it does pose a safety risk to the medical professional for the product to be supplied without the IFU, then consider using the harmonised symbol (see ISO 15223-1 and ISO 20417) on the primary packaging and supplying 1 paper IFU within the box or secondary packaging.
 
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