Hi again!
I have not encountered that restriction before from NBs. In my experience, we evaluated the potential impact caused by temporary unavailability of the internet as part of the risk assessment in Article 4, and implemented mitigations where we could. I have done this successfully with medical device software before, and one of the mitigations that was implemented to address the potential lack of internet was to have the IFU accessible within the software via a menu.
Our NB has reviewed these risk assessments and checklists of compliance in great detail and this was found to be acceptable. Of course, your mileage may vary, depending on the device type, intended use, environment, etc. If you wish to challenge this with your NB, I would suggest putting together a thorough risk assessment and reference mitigations implemented to reduce the risk.
Best,
Brittany
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Brittany Gibson BSc
Director, Quality and Regulatory Affairs
Winnipeg MB
Canada
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Original Message:
Sent: 13-Jun-2019 17:23
From: Anonymous Member
Subject: eIFU
This message was posted by a user wishing to remain anonymous
Thank you Brittany.
We already reviewed the EU No. 207/2012 and confirmed that our product falls under the scope of this regulation, however our NB still advising up that we have to provide IFU in paper format, even if demonstrating conformity with this regulation. Have you heard about this as a restriction based on possible limitations of users to access internet?
Original Message:
Sent: 13-Jun-2019 15:56
From: Brittany Gibson
Subject: eIFU
Hello Anonymous,
Depending on the type of device and use case, it might be possible to eliminate the paper IFU. If you haven't reviewed it already, check out Commission Regulation EU No. 207/2012 on electronic instructions for use of medical devices. Article 3 describes the types of devices that can be provided with eIFU instead of paper IFU.
I've done this successfully with devices before and what I found useful was creating a checklist of compliance with Regulation No. 207/2012. If you wish to provide eIFU only, a risk assessment is required per Article 4. You also have to have a system in place to provide paper copies of the IFU upon request within 7 days.
I hope this helps!
Best,
Brittany
------------------------------
Brittany Gibson BSc
Director, Quality and Regulatory Affairs
Winnipeg MB
Canada
Original Message:
Sent: 13-Jun-2019 11:24
From: Anonymous Member
Subject: eIFU
This message was posted by a user wishing to remain anonymous
Hello
A lot of questions about eIFUs. EU regulation allows having eIFU, but in practice there is a restriction to still having the IFU in paper form, assuring the user/patient have the information without depending on internet. Is there a way to completely eliminate the IFU in paper form? If not, is there a possibility to have a mix, paper form only in English, for example, and the another languages in the website or in a storage data key?
Could you advice on this topic?
Thank you!