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Domestic and International Medical Device IFU (Instructions for Use)

Java23

Involved In Discussions
#1
Hi - once again I am in need of some "experienced and seasoned" help.

I am struggling with some folks trying to explain that I feel our use of the following will only create problems and I don't know how, in the best words to convey that..........

Currently, the company has one IFU for a Class IIb product (Rx Only Device) tht is ENGLISH text only. They send this IFU to the USA only.

They have another IFU for the same Class IIb product (Rx Only Device) that contains ENGLISH and all other languages.

What I have found is that the english text has differences betweeen the manuals. My concern is that the translated language MUST be exact to the English.

Is it common practice to have 2 versions of English IFUs for the same product?


Kind regards and thank you in advance for any help/suggestions/ideas....:rolleyes::thanks:
 
Last edited:
Elsmar Forum Sponsor

sreenu927

Quite Involved in Discussions
#3
Hi - Usually, the practice is NOT to have different IFUs for the same product.

In your case, if you have IFU that has English and EU language translated versions in a SINGLE IFU (one part number), then you MUST make sure that the translated versions are exactly translated as per English Version.

However, my suggestion is, atleast now, have one IFU for one product rather than 2 IFUs and ENSURE the translated versions are properly translated inline with the ENglish version!

Regards,
Sreenu
 
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