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MDR, Annex I, 23.1 Interpretation - IFU on the website

RA_QA_Expert

Involved In Discussions
#1
Hello,

MDR, Annex I, 23.1 said:

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...

Very common interpretation is that the manufacturer must made available Instruction of Use on the website.

Questions:
Is it possible to have IFU's on website protected by login and password? Or it must be public with free access for all?
Are these information inteded for customers only or for anybody?

Any experience what is approach of notified body?

Thank you
 
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RobertvanBoxtel

Involved In Discussions
#2
Dear @RA_QA_Expert, of course you can protect it by password and make it available only to your customers. But realize, in the bigger picture, there are many types of devices. Some devices are used by patients and therefore this approach will not be possible. Also, is there a reason for not disclosing? Is there secret information in the IFU? So much hassle to organize a password access system and manage that. Is that worth the effort?
 
#3
I would suggest that the requirement is not for the entire IfU.
It does require a way of identifying a device, the manufacturer and then any safety information.
So a picture of the device, 'Contact Us' button and a list of warnings and contra-indications?
 

monoj mon

Involved In Discussions
#5
So a picture of the device, 'Contact Us' button and a list of warnings and contra-indications?
We are also practicing this in order to comply with the requirement.
Sounds like a plan! Still, would an IFU not be simpler...
If you manufacture similar types of devices where Instructions for Use are more or less the same then won't it be cumbersome to put IFU for each device! In my opinion, in such case, putting pictures of the device, contact information and a list of warnings/contra-indications shall be sufficient! You can also put the warning symbols in the website along with their descriptions that you have used on the labels.
 
#6
I am thinking that all the required information can be added to the normal marketing information - one button 'Warnings and contra-indications?'

A complete IfU (one I have immediately to hand) is over 60 pages.

I can also see that some manufacturers could be hesitant to openly share every nuance of the operation of their device, which the IfU needs to provide.
 
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