2021/2226 on Electronic Instructions for Use (IFU) for medical devices

bimeri

Starting to get Involved
We do not fall under the scope of regulation 2021/2226 on Electronic Instructions for Use (IFU) for medical devices. However, we do provide IFU in USB with the paper IFU. Can we claim that we comply with 2021/2226 on Electronic Instructions for Use (IFU) for medical devices in our Declaration of Conformity? It does not look logical to me.
 

EmiliaBedelia

Quite Involved in Discussions
2021/2226 has requirements for electronic IFUs that are made available in addition to the paper IFU for manufacturers who are not eligible to only use eIFU. My notified body has asked for detailed information on compliance to this regulation on the grounds that the IFU on the website is an "eIFU" - I would imagine the same logic applies here (and presumably you also have an IFU on your website).

Thus I would say you should claim compliance to the regulation, and somewhere in your technical documentation have the documentation/information that supports compliance.
 

bimeri

Starting to get Involved
2021/2226 has requirements for electronic IFUs that are made available in addition to the paper IFU for manufacturers who are not eligible to only use eIFU. My notified body has asked for detailed information on compliance to this regulation on the grounds that the IFU on the website is an "eIFU" - I would imagine the same logic applies here (and presumably you also have an IFU on your website).

Thus I would say you should claim compliance to the regulation, and somewhere in your technical documentation have the documentation/information that supports compliance.
Hi @EmiliaBedelia, Yes we we also have an IFU on our website.

You are referring to Article 9 of the regulation I assume. There it only says that
i) the content shall be consistent with the paper-based IFU: There we can have a RISK in our system and add a check on them as a Risk Control.
ii) the website shall fulfill the requirements in Article 7(2), points (b), (d), (e) and (f).

Does it mean that we can exclude all the other articles and do not have to comply with them?
 

EmiliaBedelia

Quite Involved in Discussions
Hi @EmiliaBedelia, Yes we we also have an IFU on our website.

You are referring to Article 9 of the regulation I assume. There it only says that
i) the content shall be consistent with the paper-based IFU: There we can have a RISK in our system and add a check on them as a Risk Control.
ii) the website shall fulfill the requirements in Article 7(2), points (b), (d), (e) and (f).

Does it mean that we can exclude all the other articles and do not have to comply with them?
Yes, the other articles would be relevant if you are replacing the IFU with an eIFU.
 

bimeri

Starting to get Involved
@EmiliaBedelia Another question: The regulation says you need to provide all previous versions of the IFUs on your website. And I checked multiple medical device manufacturer's websites, but they do not provide all the versions. Is there any exception? Did you provide them all?
 

EmiliaBedelia

Quite Involved in Discussions
You have to provide all the versions that have been made available electronically. In my case we only had a few revisions' worth of electronic IFUs so it wasn't much of a hassle to make an archive.

I personally debated about whether it's necessary to make an archive of old IFUs - I thought about just putting in a requirement in the procedure to make archived copies available going forward and not putting up old IFUs. You might be able to argue that the requirement should only apply going forward and shouldn't apply to old IFUs from before MDR. I haven't tried it so no idea whether a NB would accept that rationale or not.

In the end we decided it was a small enough effort to just put up the archive and be done with it.
 
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