Is Notified Body approval necessary for small changes to IVD IFU?


Starting to get Involved
Hi, I've not posted before but have picked up a lot of useful advice through reading posts so hope someone will be able to help me. I work for a small company in the UK that currently distribute self test IVD's, mostly imported from another EU country. While the quality of the tests are good, some of the IFU's are not-to be honest I don't know how they have been approved by a NB as they appear to have just been put through Google Translate or similar and some of the language just doesn't make sense, and/or there are spelling mistakes etc. This is especially relevant as they are for lay person use. What we want to do is to work with the other companies and amend the IFU's-not to change anything technical or regarding the use of the device, just to clarify them and make the English better, which we are prepared to do here. However we are meeting resistance from the manufacturers who argue that they would have to get the IFU approved again by their NB which would be expensive and basically it's been CE marked so it's fine. If the only changes are grammatical(and are actually making the product easier to use) do they have to resubmit the new IFU to the NB for approval? It's a shame because the tests are good but can be hard to sell for this reason.


Hi Nickie.
Welcome here to the COVE.
The NB do not approve the IFU. its the company who do. NB would look at the system that is in place to address translation requirements. As a part of the technical file, all IFU's would be covered. Obviously the manufacturer does not seem to have a good translation requirement procedure (and the NB also is not rated perhaps)
One is free to make changes and improvements in the IFU's and ensure the same is done across in all the other languages IFU's that you have decided to make. They also get proper revision control.
This Manufacturer's response is more based on ignorance or their regulatory is weak.
If there happen to be a vigilance report or a reported case of unclear / wrong IFU, your manufacturer stands to have his CE suspended.


Hello Nickie.

Firstly a distributor cannot modify an IFU without being considered the manufacturer of the device and would have to comply with all the legal obligations that go hand in hand- Art R6, Annex I, Decision No 768/2008/EC. See Art 2 for obligations; and

secondly, if the manufacturer wishes to make changes that result in no significant difference, there would be no requirement for involvement with the NB.


Starting to get Involved
I agree with all of the posters that for grammatical changes notified body approval is not necessary. As for your supplier: :nopity:

You may want to negotiate and have them use a printing company who offers translation certificates. This was a dollar well spent at my previous company when we were translating into languages that were not native to our own.
But if you are not worried about the risk associated with incorrect use due to translation errors, this option may not be warranted.


Starting to get Involved
Thanks for your reply. We do not want or intend to amend the IFU without the involvement of the manufacturer nor assume any of their responsibilities. We just want to work with them to produce a better product that would hopefully be more acceptable to the UK market and sell more. I just don't understand why even from a commercial point of view they are so reluctant to consider it.


Hello again Mickie. Check NB section in the IVD Directive. I can't link at the moment, but the answer is there.
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