Electronic Package inserts

[TDX-2]

OK...I am told that the answer to this is 'common sense', but honestly, I have learned not to rely on that as a basis for regulatory-type judgement calls.
In the spirit of going green and saving on printing and packaging costs, I have suggested using preloaded and content-protected flash drives to replace the printed package insert (~8 pages). The flash drive would also contain all of the translations of the insert, MSDS, COA, other related information. Since our assay requires raw data to be transferred from instrument to a separate PC, the flash drive would also serve as a mechanism to accomplish that.
The flash drive would be marked with the 'information icon' (book, small i) and the assay name. At most a card could be inserted to direct users to the information on the flash drive.
Is this idea compliant with IVD regs? I cannot find any requirement that the information be printed.

[Crimson]

That's a very interesting approach.

Since the IVDD permits electronic labeling (as opposed to the MDD), I believe this would be allowed - however, you should verify with your Notified Body - this particular implementation is somewhat novel.

Of course, you have to be prepared to supply hardcopy at the customer's request...

[somashekar]

In Reply to Parent Post by TDX-2

OK...I am told that the answer to this is 'common sense', but honestly, I have learned not to rely on that as a basis for regulatory-type judgement calls.
In the spirit of going green and saving on printing and packaging costs, I have suggested using preloaded and content-protected flash drives to replace the printed package insert (~8 pages). The flash drive would also contain all of the translations of the insert, MSDS, COA, other related information. Since our assay requires raw data to be transferred from instrument to a separate PC, the flash drive would also serve as a mechanism to accomplish that.
The flash drive would be marked with the 'information icon' (book, small i) and the assay name. At most a card could be inserted to direct users to the information on the flash drive.
Is this idea compliant with IVD regs? I cannot find any requirement that the information be printed.

From what I read and understand your product is used by a professional and certainly not directly by the patient or the user. If this is the case than you have it fine. Now is the flash drive compatible with all machines and OS ? Would there be a chance that some professional says ... Hey this does not work on my system ?

[TDX-2]

Thank you for your quick reply.
In answer to your question about compatibility...no, that's not a concern. There is only one instrument so far that this would apply to.

Best Regards,

[yodon]

Interesting discussion and something that's probably very leading (bleeding?) edge - which may cause some reaction.

Since the flash drive would be an electronic component, do you have to worry about WEEE? I wonder if there has to be any special testing to ensure the flash drive's robustness?

Certainly not trying to discourage, just thinking out loud of what issues might come up. I'm looking forward to hearing more of how this plays out.