2017/745 (MDR) - Instruction for use (IFU) - manufacturer's website

[Ioko]

Hi,

I am wondering if the IFU and operator manual must be on the manufacturer's website under the new MDR (concerning a class IV MD)? Or do we have to make available on the website just the information below and not necessary all of the IFU and the operator manual? In the case of a eIFU with all of these information, is it required to also make available an electronic version of the operator manual?

The MDR states the following:

Annex I, Chapter III, paragraph 23.1: Each device shall be accompanied by the information needed to identify the device and its manufacturer, and by any safety and performance information relevant to the user, or any other person, as appropriate. Such information may appear on the device itself, on the packaging or in the instructions for use, and shall, if the manufacturer has a website, be made available and kept up to date on the website.

However, there is also this information: Instructions for use may be provided to the user in non-paper format (e.g. electronic) to the extent, and only under the conditions, set out in Regulation (EU) No 207/2012 or in any subsequent implementing rules adopted pursuant to this Regulation.

Thank you for your help

 

[Jean_B]

Splitting the tree (noting that IFU can mean any and all accompanying documentation types such as quickstarters, IFU's, manuals, etc) :

• Accompanying the device you must send a hardcopy (paper) IFU, unless you meet the requirements of the eIFU regulation in which case you may send a digital copy (or both).

Separate from that is:

• If you (as a manufacturer) have a website, you must make available up-to-date IFU's.
  • Now this can turn into fun if you have model versions floating around, as you might need to do configuration management on which manual(s) goes with which version(s), and might need to make multiple versions of a manual available. Can you say""additional risk due to mix-up of manual version"? And better learn your corrigendum strategy for retro-actively applied Field Safety notices.

Combining the two: you must always provide a IFU with the device as well as making available the most appropriate IFU on your website (if you have a website). While the website IFU is obviously digital, the device IFU may only be digital in the prescribed conditions.
I expect some play with 'make available' as the Blue guide's definition might lead to arguments that allowing orders for paper manuals to be shipped covers this requirement, but the intent is clear in the subtext and it should be digital.

*note: this is as I read it from years of reading vs cases encountered. It doesn't hold any legal value, but it's a good indication of supported reasoning many professionals can agree on.

 

[dgrainger]

Yes, you have to reproduce the relevant information on a website if you have one.

BTW, isn't your 'operator manual' actually considered to be the IFU?

There is an implementing act due on eIFU. The draft is out for comment with Competent Authorities at the moment.

 

[Ioko]

Splitting the tree (noting that IFU can mean any and all accompanying documentation types such as quickstarters, IFU's, manuals, etc) :

• Accompanying the device you must send a hardcopy (paper) IFU, unless you meet the requirements of the eIFU regulation in which case you may send a digital copy (or both).

Separate from that is:

• If you (as a manufacturer) have a website, you must make available up-to-date IFU's.
  • Now this can turn into fun if you have model versions floating around, as you might need to do configuration management on which manual(s) goes with which version(s), and might need to make multiple versions of a manual available. Can you say""additional risk due to mix-up of manual version"? And better learn your corrigendum strategy for retro-actively applied Field Safety notices.

Combining the two: you must always provide a IFU with the device as well as making available the most appropriate IFU on your website (if you have a website). While the website IFU is obviously digital, the device IFU may only be digital in the prescribed conditions.
I expect some play with 'make available' as the Blue guide's definition might lead to arguments that allowing orders for paper manuals to be shipped covers this requirement, but the intent is clear in the subtext and it should be digital.

*note: this is as I read it from years of reading vs cases encountered. It doesn't hold any legal value, but it's a good indication of supported reasoning many professionals can agree on.

Hi Jean_B,
Thank you for your answer.

 

[Ioko]

Yes, you have to reproduce the relevant information on a website if you have one.

BTW, isn't your 'operator manual' actually considered to be the IFU?

There is an implementing act due on eIFU. The draft is out for comment with Competent Authorities at the moment.

Hey,

Thank you for your answer, yes actually the operator manual has to be considered as an IFU.

 

[Highground]

I'm trying to understand this requirement.
With a class llb device, under the MDR with the Reg 207/2012 Instructions for use may be provided to the user in non-paper format (e.g. electronic) to the extent, and only under the conditions, set out in Regulation (EU) No 207/2012 or in any subsequent implementing rules adopted pursuant to this Regulation.
Our device does not fall under the 207/2012 regulation, but we have a website. Does this still mean we need to provide the IFU on the website and a paper copy??

 

[Jean_B]

I'm trying to understand this requirement.
With a class llb device, under the MDR with the Reg 207/2012 Instructions for use may be provided to the user in non-paper format (e.g. electronic) to the extent, and only under the conditions, set out in Regulation (EU) No 207/2012 or in any subsequent implementing rules adopted pursuant to this Regulation.
Our device does not fall under the 207/2012 regulation, but we have a website. Does this still mean we need to provide the IFU on the website and a paper copy??

Once you claim/certify your device as CE compliant under the EU MDR, yes.
Under plain old MDD, no.
Under extended MDD without significant change? Will probably depend on your notified body, with most of the pragmatic ones probably going not until significant change and the carefully treading ones perhaps going the route of 'get it in order already, you'll need it later in any case and you wouldn't/shouldn't extend a dying product anyway'.

 

[Highground]

Once you claim/certify your device as CE compliant under the EU MDR, yes.
Under plain old MDD, no.
Under extended MDD without significant change? Will probably depend on your notified body, with most of the pragmatic ones probably going not until significant change and the carefully treading ones perhaps going the route of 'get it in order already, you'll need it later in any case and you wouldn't/shouldn't extend a dying product anyway'.

On further inspection I found the following:
EU MDR, Chapter III, 23.1 gives the general requirements for information supplied by Manufacturer. E.g. IFUs.
‘Each device shall be accompanied by the information needed to identify the device and its
manufacturer, and by any safety and performance information relevant to the user, or any other
person, as appropriate. Such information may appear on the device itself, on the packaging or in the
instructions for use, and shall, if the manufacturer has a website, be made available and kept up to
date on the website, taking into account the following:’

‘23(f) Instructions for use may be provided to the user in non-paper format (e.g. electronic) to the
extent, and only under the conditions, set out in Regulation (EU) No 207/2012 or in any
subsequent implementing rules adopted pursuant to this Regulation.’

‘Regulation (EU) No 207/2012 Article 2
For the purposes of this Regulation, the following definitions
shall apply:

‘(d) ‘fixed installed medical devices’ means devices and their
accessories which are intended to be installed, fastened or
otherwise secured at a specific location in a healthcare
facility so that they cannot be moved from this location
or detached without using tools or apparatus, and which
are not specifically intended to be used within a mobile
healthcare facility.’

Our devices are excluded because they do not meet (d) definition required within Article 2. Therefore we must not put it on the website.

 

[L_O_B]

I had this discussion with a customer (longer than it should have been) and then this customer had this discussion with its notified body (very short).
Here are the results:

• 23.1 does not necessarily refer to the IFU. "information needed to identify the device and its manufacturer, and by any safety and performance information relevant to the user, or any other person, as appropriate" can also be assembled seperately.
• This implies that this requirement applies regardless of the scope/requirements of 207/2012. Every manufacturer who has a website, must provide this information on the website.
• If the manufacturer decides to use the IFUs to comply with this requirement, he does not necessarily have to comply with 702/2012. This regulation still only applies, if the manufacturer does not intend to provide the IFU in paper form with the device: "This Regulation establishes the conditions under which the instructions for use of medical devices [...] may be provided in electronic form instead of in paper form."

 

[Jean_B]

Our devices are excluded because they do not meet (d) definition required within Article 2. Therefore we must not put it on the website.

TLDR: no. That intent of that regulation focuses on 'electronic/digital' instead of 'paper', the EU MDR intent reads as 'digital/electronic' in addition to 'paper' if you have paper.

Note that 23.1.(f) "Instructions for use may be provided to the user in non-paper format (e.g. electronic) to the extent, and only under the conditions, set out in Regulation (EU) No 207/2012 or in any subsequent implementing rules adopted pursuant to this Regulation." is a seperate requirement, following 23.1 "Each device shall be accompanied by the information needed to identify the device and its manufacturer, and by any safety and performance information relevant to the user, or any other person, as appropriate. Such information may appear on the device itself, on the packaging or in the instructions for use, and shall, if the manufacturer has a website, be made available and kept up to date on the website, taking into account the following:"
The italic part states that information to identify the device, identify the (legal) manufacturer and any safety/performance information relevant to user (or other persons as appropriate).
The underlined part states that it will appear and/or: on the device (i.e. actual device label, on-screen, other methods such as engraving etc.), on its packaging (labelling) or in the instructions for use (manual, leaflets, all of the far too various methods to mention).
The bold part states that the italic part must (if the (legal) manufacturer has a website) make that information available online.
the bullet items pertain to if, what and how such information is displayed.

23.1.(f) refers to a regulation (EU No 207/2012) whose first whereas point states "For some medical devices the provision of instructions for use in electronic form instead of in paper form can be beneficial for professional users." and first article states "...may be provided in electronic form instead of in paper form..." there are other points, but the intent there is to go for electronic instead of paper if it is more beneficial for the user (where benefit is not (only) from the reduced cost or weight, but from increased searchability, on-device/site availability (e.g. automatic depending on step or relevancy ranked from origin of search), clarity (through e.g. animation or spoken instructions)). The devices for which this is acceptable and how it should be done to cover risks is then the subject of the remainder of that regulation. It then locks down by stating if you go this path you would still need to have a paper format and have the electronic one on the site as well.

Within 207/2012, article 2 (d) is a definition and not a selection criteria. The confusion might arise from Article 3 which opens with paragraph 1: "1. Subject to the conditions set out in paragraph 2 manufacturers may provide instructions for use in electronic form instead of in paper form where those instructions relate to any of the following devices:...<a list of characteristics>" where paragraph 2 sets out the conditions, i.e. solely professional users.

The above is read (mostly) from the viewpoint of intent. The age of that regulation and non-alignment with MDR will lead to the need for interpretation. But the 'instead' differentiates it from the 'in addition to' variant of the EU MDR. Else there would have been no need to add the point under 23.1., as it would have been simpler for 23.1.(f) to change its 'may' to 'must'. I suspect 207/2012 will be redrafted to fit better.
My standpoint/advice: check if you have a website. If yes: keep and already do all of the best practice from regulation EU 207/2012 (risk-assessment and the minimum risk control options, certain record-keeping requirements, validation of the electronic format, GDPR awareness, configuration management matching device versions to electronic information versions, secure but freely accessible formats (e.g. securely signed PDF's), need to keep and make available a paper format as well). If you worry about competitors sneak-peeking then perhaps authentication as well, but you might run afoul of riskless availability.
It wouldn't amaze me if later down the line someone would get the 'bright' idea to try and couple these per UDI in EUDAMED. Medical devices won't be becoming cheaper because of this.