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IFU on web page - Consequences if the most recent one is not uploaded

SANE

Registered
#1
We are manufacturer of IVD products (IVDD "others") and have IFU in paper form which is enclosed in the kit package. Additionally we upload the IFU on our web page.
Please can you tell me whether all revisions have to be remain there even if a newer revision will be uploaded?
What is the consequence if the last IFU on the web is not the most updated one , although the newest one (paper form) has been enclosed in the kit package? Is a report to the authority (in Germany BfArM) required in this case, even if there was no risk caused by the delay of upload.
Thanks in advance for your assistance
 
#2
Hi SANE,
You are providing the IFU in paper format and thus meeting the regulatory requirement.
It seems to me that what you are providing in your website is a nice addition with a low probability of risk to the user. Unless there is a potential for a safety issue because of conflicting information between IFUs I would not consider turning to the competent authority.

I would only keep the latest electronic version in your website. Keeping multiple versions is actually confusing to customers.

Shimon
 
#3
Under IVDMDR you need to provide IFU for each device on your website (if you have one) - so you will probably need relevant versions for all devices that are still in use.
You could consider a consolidated version.
 

SANE

Registered
#4
Thanks shimonv and dgrainger.

OK, keeping all revisions on the webpage which could be in products still used in the market is something I remember and this will be possible. I will consider the consolidated version.

What me still confuses is that our QM expert tells me that we have to report the lack of the last IFU revision on our web to the German authority BfArM. We have not changed anything which lowers or increases risks.
Under IVDMDR you need to provide IFU for each device on your website (if you have one) - so you will probably need relevant versions for all devices that are still in use.
You could consider a consolidated version.
 
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