2017/745 (MDR) - Instruction for use (IFU) - manufacturer's website
- Thread starter Ioko
- Start date
This thread is so helpful... Thanks to all who responded! Can someone help answering the following as well?
1. For a Class I device out of scope of EU Reg. No. 207/2012, we still add "eIFU" symbol in addition to the "open book" symbol. We also supply paper IFUs. This is because I have interpreted ISO 15223-1:2016 "eIFU" symbol to mean that if we provide instructions for use on the website, this helps the user to find the IFU on the website if needed.
QUESTION 1: Is this an acceptable interpretation? I would love to know from others' experiences with notified bodies.
1. For a Class I device out of scope of EU Reg. No. 207/2012, we still add "eIFU" symbol in addition to the "open book" symbol. We also supply paper IFUs. This is because I have interpreted ISO 15223-1:2016 "eIFU" symbol to mean that if we provide instructions for use on the website, this helps the user to find the IFU on the website if needed.
QUESTION 1: Is this an acceptable interpretation? I would love to know from others' experiences with notified bodies.
Highground
Involved In Discussions
Is there any updates on this by any chance?
dgrainger
Trusted Information Resource
Sorry, I don't know. We were still in the EU back in 2019
This is very helpful information. And, if anyone is still watching this thread, I have a new twist.
Most companies interpret the information that needs to be posted as being the entire IfU/user manual on the website. I like the interpretation that the specific information can be posted.
Now, what if you only have one instance of the device? What if it is a cloud-based, software-only device that will only ever have one instance and only ever be accessible through your website? Do you have to provide information for multiple versions of the device if there won't be multiple versions in use? And, do you have to provide the information separately on the website from the actual area of the website where you login and use the device?
Most companies interpret the information that needs to be posted as being the entire IfU/user manual on the website. I like the interpretation that the specific information can be posted.
Now, what if you only have one instance of the device? What if it is a cloud-based, software-only device that will only ever have one instance and only ever be accessible through your website? Do you have to provide information for multiple versions of the device if there won't be multiple versions in use? And, do you have to provide the information separately on the website from the actual area of the website where you login and use the device?
Sullen-gent
Involved In Discussions
Our consultant told us we have to keep the old IfUs online as. Having a look for this requirement and don't see it.
Can anyone help and let me know if we do need to make the previous revision available online as well as the current?
Can anyone help and let me know if we do need to make the previous revision available online as well as the current?
Article 7(2) of Commission Regulation (EU) No 207/2012 says,
"Any website containing instructions for use of a device which are provided in electronic form instead of in paper form shall comply with the following requirements:
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(g) all previous versions of the instructions for use issued in electronic form and their date of publication shall be available on the website."
"Any website containing instructions for use of a device which are provided in electronic form instead of in paper form shall comply with the following requirements:
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(g) all previous versions of the instructions for use issued in electronic form and their date of publication shall be available on the website."
Sullen-gent
Involved In Discussions
Brilliant, but question from me is this applicable? We aren't supplying an electronic IFU inline with this 207/2012 legislation as we are providing a paper copy and don't qualify to provide only an electronic IFU.
Does this recommendation apply to all medical devices then?
Article 9 of Commission Regulation (EU) No 207/2012 says,
"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.
Where such instructions for use are provided through a website, this website shall fulfil the requirements set out in points (b), (e) and (g) of paragraph 2 of Article 7."
"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.
Where such instructions for use are provided through a website, this website shall fulfil the requirements set out in points (b), (e) and (g) of paragraph 2 of Article 7."
