This message was posted by a user wishing to remain anonymous
I haven't searched today, but a year ago I saw that Depuy had this format on their website - showing the archive copies. I remember using it as an example to show a colleague.
Original Message:
Sent: 31-Mar-2023 08:55
From: Anonymous Member
Subject: REGULATION (EU) 2021/2226 – electronic IFUs
This message was posted by a user wishing to remain anonymous
My apologies to the Forum. I posted this question without researching previous posts beforehand. I now see that this topic has been covered in several previous posts. My question is answered by those posts, but I still have not seen any medical device website with multiple e-IFU revisions.
Also, the information provided by this Forum has been invaluable in my regulatory effort. I appreciate all those who take the time to provide guidance. I believe your input has advanced the entire regulatory compliance effort. I trust the information here more than any other source.
Anon
Original Message:
Sent: 29-Mar-2023 15:13
From: Anonymous Member
Subject: REGULATION (EU) 2021/2226 – electronic IFUs
This message was posted by a user wishing to remain anonymous
We are a manufacturer of a Class IIa device that is packaged with a paper IFU. We have a company website that includes a link to the current IFU revision, only. Are we required to post all historical revisions that have been available on the website? …and post them for the 10 and 15 years, as specified in Article 5(9), (10)? I've never seen multiple e-IFU revisions posted on other manufacturers' sites. Thanks in advance!!!<o:p></o:p>
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REGULATION (EU) 2021/2226 Article 1 reads:<o:p></o:p>
It [this Regulation] also establishes certain requirements concerning contents of and websites for instructions for use that are provided in electronic form in addition to instructions for use in paper form.<o:p></o:p>
<o:p> </o:p>
Article 9 reads:<o:p></o:p>
Instructions for use in electronic form, which are provided in addition to complete instructions for use in paper form, shall be consistent with the content of the instructions for use in paper form.<o:p></o:p>
Where such instructions for use are provided through a website, this website shall fulfil the requirements set out in Article 7(2), points (b), (d), (e) and (f).<o:p></o:p>
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Article 7(2)(f) reads:<o:p></o:p>
all previous versions of the instructions for use issued in electronic form as referred to in Article 5, point (13), and their date of publication shall be available on the website.<o:p></o:p>