Instructions for Use supplied with Medical Device Components

[rishurathee]

Hi,

In EU MDR or MDD, is there is a specific requirement for a having IFU/User Manual/Operator's Manual/Or anythig else in CE Marked supplied medical device?

I have a situation with my subject device which is class IIb under MDD/MDR. The subject device has two components (catheter and a battery powered component) that works together to achieve the primary intended purpose of subject device. These two components are sterilized, packaged and shipped separately to end user. We have one IFU for the subject device that explains how both components need to work together and explains everything...

Now, the catheter component is packaged and shipped with the subject device IFU. However, the other battery powered component is packaged and shipped without IFU in it (and yes it is shipped individually to the end user). Moving forward in MDR, we have battery operated component CE Marked individually. Hence, I am looking for a reference to regulation (if any) that call out the requirement of having an IFU in the CE Marked shipped medical device.

Note: We are aware that we have packaging and shipping complexity and ideally we should somehow package them together. However, we cannot package them together beacuse the battery powered component is considered as a hazadeous item in many EU Countries and it should be shipped individually.

Any leads, guidance, expert advice would be highly appreciated.. thank you in advance.

 

[HeadlessChicken]

I may be wrong, but I think that in specific cases you can put your IFU in the manufacturer's website, provided that you print this website address somewhere in the packaging.


Hopefully this may help

(Sorry, I have tried to post a link to this Regulation, but because my post count is so low the website won't let me. You can google for this regulation however, it should bring the relevant document I was trying to link to)

COMMISSION IMPLEMENTING REGULATION (EU) 2021/2226 of 14 December 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards electronic instructions for use of medical devices



I'm still getting experienced with MDR so apologies if it's no help.

 

[rishurathee]

Thank you for sharing the link. I appreciate you gave your time. We have already explored this pathway and omy device doesnot qualify for only eIFU. Its hybrid (paper +eIFU) for us.

 

[HeadlessChicken]

I'm sorry I couldn't be more help.

Hopefully someone with more knowledge will come along.

Good luck!

 

[EmiliaBedelia]

Yes. MDR Annex I 23.1(d).