Q
Hi,
We're in the process of looking at implementing QS changes that will allow for the use of eLabeling of Instructions for Use (IFU), but I'm anticipating a problem when we implement a new system. The directive asks that we perform a risk assessment that shows the risk using eLabeling is less than or equal to the risk of continuing to provide this in hard copy with the product (with the hazardous situation of potential loss of access to the eIFU).
The way that I was interpreting this was to identify any content of the IFU that always needs to be available (example: if there were a table containing balloon catheter pressures to use based on the liquid in the catheters. This kind of information may have been taped up on the equipment previously by the user and our mitigation of temporary eIFU access situation may be to provide this information in hard copy form with the product.
My concern is that a group could possible get carried away and may feel that all cautions and warning statements need to be provided in paper form. Others may feel that regulatory markings and mandated statements might also need to be provided in paper form. This would kill any saving possibilities as we could have paper IFUs with all product and each would need to be available in multiple translations.
I've been looking for a statement in a directive that may clarify this and I haven't found it. Does anyone have any reference to a directive document that clarifies this point? or is it just something that we should assume since the regulations mandate that certain information go in the IFU and this directive allows us to place it in an eIFU?
Thanks. I really appreciate your help on this one.
We're in the process of looking at implementing QS changes that will allow for the use of eLabeling of Instructions for Use (IFU), but I'm anticipating a problem when we implement a new system. The directive asks that we perform a risk assessment that shows the risk using eLabeling is less than or equal to the risk of continuing to provide this in hard copy with the product (with the hazardous situation of potential loss of access to the eIFU).
The way that I was interpreting this was to identify any content of the IFU that always needs to be available (example: if there were a table containing balloon catheter pressures to use based on the liquid in the catheters. This kind of information may have been taped up on the equipment previously by the user and our mitigation of temporary eIFU access situation may be to provide this information in hard copy form with the product.
My concern is that a group could possible get carried away and may feel that all cautions and warning statements need to be provided in paper form. Others may feel that regulatory markings and mandated statements might also need to be provided in paper form. This would kill any saving possibilities as we could have paper IFUs with all product and each would need to be available in multiple translations.
I've been looking for a statement in a directive that may clarify this and I haven't found it. Does anyone have any reference to a directive document that clarifies this point? or is it just something that we should assume since the regulations mandate that certain information go in the IFU and this directive allows us to place it in an eIFU?
Thanks. I really appreciate your help on this one.
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