Hello,
What that last poster said is correct and reasoning behind keeping the historical versions of electronic version of IFU (e-IFU) on the website. If the company is providing software or equipment, the customer may have the last version or even previous versions of the equipment/software. Therefore, configuration management is quite important to link up the correct IFU (and e-IFU) to the version of software or equipment which the customer may have. As an example, an IVD instrument which has software version 1.8, there may also be version 2.0 and 2.2 in use as well. Some of the software changes most likely would have updated the IFU, so this needs to be linked to the version of software. And there may also be hardware changes to the equipment like new sensors or reader which needs to be clearly identified. To answer the original question: it is the medical device manufacturers responsibility to ensure the versions of IFU are linked to the product being shipped and what would be available as electronic versions on the website (configuration management).
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 24-May-2022 09:49
From: Anonymous Member
Subject: (EU) 2021/2226 - Article 5
This message was posted by a user wishing to remain anonymous
Considering these eIFUs are specifically meant for use by professionals you can incorporate a watermark that is clearly visible on the document showing the IFU has been superseded. You have to consider that some users may have older equipment and so not all new updates might be relevant to them. Therefore have a system where the equipment version/IFU version is very apparent. You could for instance choose a color code scheme on the margins of the IFU to differentiate or something more distinctive
Original Message:
Sent: 23-May-2022 20:03
From: Anonymous Member
Subject: (EU) 2021/2226 - Article 5
This message was posted by a user wishing to remain anonymous
Dear all,
I am working to address one of the requirements in the eIFU regulation (EU) 2021/2226 and curious to see how other companies are working in compliance with the requirement.
Under article 5, section (13), the regulation states the following: all issued historical electronic versions of the instructions for use shall be available on the website.
So, this means that we need to provide all previous versions of any IFU on the website. To avoid users from downloading the wrong versions, are companies providing current and previous versions on separate webpage i.e., a hyperlink that opens all previous versions of IFUs in a separate link.
Is it acceptable to provide a link to request prior versions and upon a request from any user, paper copies are shipped within a sepcific period?
Thanks!