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.