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EU No 207/2012 is the law which allows for the implementation of electronic IFUs in the EU. Article 5 indicates that IFUs can be provided instead of paper under the following conditions:
(9) for devices with a defined expiry date, except implantable devices, they shall keep the instructions for use available for the users in electronic form for at least 2 years after the end of the expiry date of the last produced device;
(10) for devices without a defined expiry date and for implantable devices, they shall keep the instructions for use available for the users in electronic form for a period of 15 years after the last device has been manufactured.
Does this mean that the a manufacturer looking to use a third party eIFU provider to support the electronic distribution of eIFUs, would be tied to that third party supplier for that 15 year period? What happens if the third party supplier stops doing business within this time period?
Hope some can provide a little enlightenment.
Thanks.