EIFU indicator symbol - Class I labels as per EU MDR

[destroyed9218]

Hi,
I am redlining Class I labels as per EU MDR. My question is do I need eIFU indicator symbol on the paper IFU even if electronic IFU is not provided? I am assuming the products we are working on will have both paper and electronic IFU(in the near future).

 

[SKM.Sunil]

Hi,
I am redlining Class I labels as per EU MDR. My question is do I need eIFU indicator symbol on the paper IFU even if electronic IFU is not provided? I am assuming the products we are working on will have both paper and electronic IFU(in the near future).

NO, You can't adopt a symbol, without having the eIFU on place. eIFU is not only to be symbolize, also you have to provide with a link (QR code may helpful), where it is placed/located.
Yes, you have to have a eCopy in future and you can provide your eIFU symbol and link that time.

NOTE: eIFU will not only be the electronic version of your paper IFU. Here you can demonstrate more like a video, animations etc. to easily demonstrate more complected procedures to the intended user of the device. In other words, It can solve end user training/awareness much more efficiently.
[ As we know few devices intended to be used by lay persons, hence it may help in making them understand the device and its applications.
this can suffice the GSPR 22 (22.1,22.2,22.3) Annex-I requirements]

<This above note can be utilized by all manufacturer>

 

[beboss123]

Agree with above. Putting an eIFU symbol means that you have implemented eIFU in accordance with the 207/2012 directive. Meaning you need to make sure your device meets the requirements of 207/2012 (it is in effect as of today may be repealed soon or updated for 2017/745) for eIFUs including eligibility for your device (professional use devices only). Make sure despite it being a Class I device, you meet the requirements for the controls (risk assessments, security, etc.)

 

[Kuldeep Singh]

Hello Everyone,

We are plan to provide the IFU in electronic form as well as paper form for our Class IIb X-Ray medical device. So please guide me applicable Articles of eIFU Directive EU 207/2012 to us. As i read the directive and come to know that only Article 9 applicable to us. Rest of articles applicable to manufactures which provide the IFU in electronic form only.

Please guide me if i am wrong.