Hi,
I am wondering if the IFU and operator manual must be on the manufacturer's website under the new MDR (concerning a class IV MD)? Or do we have to make available on the website just the information below and not necessary all of the IFU and the operator manual? In the case of a eIFU with all of these information, is it required to also make available an electronic version of the operator manual?
The MDR states the following:
Annex I, Chapter III, paragraph 23.1: Each device shall be accompanied by the information needed to identify the device and its manufacturer, and by any safety and performance information relevant to the user, or any other person, as appropriate. Such information may appear on the device itself, on the packaging or in the instructions for use, and shall, if the manufacturer has a website, be made available and kept up to date on the website.
However, there is also this information: Instructions for use may be provided to the user in non-paper format (e.g. electronic) to the extent, and only under the conditions, set out in Regulation (EU) No 207/2012 or in any subsequent implementing rules adopted pursuant to this Regulation.
Thank you for your help
I am wondering if the IFU and operator manual must be on the manufacturer's website under the new MDR (concerning a class IV MD)? Or do we have to make available on the website just the information below and not necessary all of the IFU and the operator manual? In the case of a eIFU with all of these information, is it required to also make available an electronic version of the operator manual?
The MDR states the following:
Annex I, Chapter III, paragraph 23.1: Each device shall be accompanied by the information needed to identify the device and its manufacturer, and by any safety and performance information relevant to the user, or any other person, as appropriate. Such information may appear on the device itself, on the packaging or in the instructions for use, and shall, if the manufacturer has a website, be made available and kept up to date on the website.
However, there is also this information: Instructions for use may be provided to the user in non-paper format (e.g. electronic) to the extent, and only under the conditions, set out in Regulation (EU) No 207/2012 or in any subsequent implementing rules adopted pursuant to this Regulation.
Thank you for your help