Julie Omohundro It probably also means that the manufacturer should pay for postage to mail the printed copy.

Brian Matthews I agree that it is ambiguous but I understand that the intent was to ensure that there would be no charge for the provision of the printed version of the IFU. For some devices with complex IFUs the cost of producing the printed version is not negligible and it was intended to ensure that this would not be passed on to the device users.

G M Butcher In the two cases of the phrase "at no additional cost", the meaning applies to the paper version of the IFUs. The first instance applies to your organization having a system to provide the IFUs. The second instance requires a reference within the e-IFUs for obtaining the paper version. It does not apply to maintaining a toll free number unless that is part of your 'system'.

It means as most of the manufacturer are moving to the electronic IFU which can be downloaded by the user through the company's website. It can provide a great advantage to people if the electronic IFU is also provided in audio and video version . I guess most of the company's do provide . This in turn greatly reduces the price that manufacturer had to bear to print the IFU's to provide along with each device .

within our business we have performed small benchmark, but apparently always still a printed IFU is offered besides an Electronic version. Or do you know examples of manafacturers within consumable products which have converted 100% to electronic?

regarding costs:
I agree with Brian. it means a customer has to be able to obtain a printed version at no additional charge. Depending on your market, it might be required to have an IFU accessible at all times. This would impose additional costs for the customer, if they have to pay for it or print it themselves. So this regulation protects them from increased costs. which leads me to ...

... the 100% electronic question by Agnes.
yes, I have such a product in my portfolio. we have never ever printed and shipped an IFU for it. However, there are some requirements, mainly: the device needs to be capable to display the IFU for starter!
in my case: Software as Medical Device and the IFU is displayed as PDF.
Devices like a blood glucose meter will always need a printed IFU due to small displays.
And like stated above: some markets require a printed version by law, no matter if the device is capable of displaying the IFU or not. (ambulances, for example ;-))