Is there a specific regulatory requirement for 100% inspection of IFUs?

E

ElmerF

#1
Is there a specific regulatory requirement for 100% inspection of IFUs? If not what is standard practice for inspection of IFUs for medical devices (US and EU territories). Once the artwork has been approved, is it sufficient to perform an FAI and for routine incoming inspection to consist of verifying the revision number?

Thanks for your input.

ElmerF
 
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somashekar

Staff member
Super Moderator
#2
Is there a specific regulatory requirement for 100% inspection of IFUs? If not what is standard practice for inspection of IFUs for medical devices (US and EU territories). Once the artwork has been approved, is it sufficient to perform an FAI and for routine incoming inspection to consist of verifying the revision number?

Thanks for your input.

ElmerF
Label and other matter supplied with the medical device or even prior as product information more said as "Information supplied to customer" must be true to specification, regulatory, performance and safety. There must be no misrepresentation or false claim or lack certain vital manufacturer information, product information, symbol information, control method captured within the information material.
With all this said, it is not the 100% inspection that will be the focus, rather it is about the approval mechanism. Art work approval comes within this. There are places where the factory prints the complete "Information supplied to customer" rather than purchase from an other printing house. The approval mechanism here as well plays a vital role.
Your label control procedure (call it more as control of information supplied to customer) must be strong post approval. More than the 100% stuff, concerns are in the use of obsolete version labels and other material as well as wrong use of safety mark on medical devices.
 
Last edited:

yodon

Staff member
Super Moderator
#3
As Somashekar said, control is key. To answer your specific question, I don't know of any regs requiring 100% inspection. FAI is appropriate; however, a variety of errors can occur (printing, cutting, folding, ...) and so I would expand the periodic sampling to a more comprehensive review than just the revision number.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Hi,

I am not aware of a 100% IFU inspection regulatory requirement.

It all comes down to a risk analysis - how critical (and likely) would any discrepancy be (not just content-wise; consider any and all aspects of the IFU, or labeling in general). When purchasing from an external source, take into account the supplier's characteristics and performance over time. BTW, all this is applicable in almost any sort of incoming inspection, not just labeling materials.

In most low-risk cases I believe that once FAI is successful, verifying the version for each incoming batch (sample as appropriate) would do; assuming that the supplier approval process is appropriately rigorous.

Cheers,
Ronen.
 
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