Article 18: Implant Card and information to be communicated.

#1
There have been a number of individual questions about the Implant Card (IC), but I'd like to focus on the information that is specifically not the IC itself.

1(a) of this article tells you what must be on the IC, 1(a) through 1(d) tells you what information needs to be provided together with the device. The following paragraph says that 1(a) through 1(d) "shall be provided, for the purpose of making it available to the particular patient who has been implanted with the device, by any means that allow rapid access to that information," "shall be written in a way that is readily understood by a lay person," and "updated where appropriate. Updates of the information shall be made available to the patient via the website mentioned in point (a)". I've been calling this the Patient Leaflet just as a way to designate it.

The MDCG GROW guidance document on Implant Cards raises the topic of a different Leaflet: an IC Leaflet that tells how to fill out the IC and explains its symbols. This IC Leaflet does not seem to be described in the MDR at all, but is introduced by this guidance. This guidance also does not touch on the Patient Leaflet requirement.

Out and about on the internet, I've seen very little discussion, or suggested format, etc. on the Patient Leaflet, which surprises me. There isn't actually any name for it, but I've looked around based on Implant Card and Article 18 and a few other search terms. A BSI presentation from Jan 2019 talked about it a little bit, and pointed out that it is a requirement of Annex I 23.4 (aa) that the IFU contains all Article 18 clause 1 a-d information. Could an eIFU containing this information be sufficient to meet the "provided together with the device" requirement, the "provided ... that allow rapid access" requirement, and the "Updates ... made available ... via the website" requirement?

I would love any feedback on what people are doing, or considering doing.
 
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#2
Hello Kat C

The patient implant card is part of your device. To fill the card is part of the workflow during the intended use of the device. Therefore and independent of the guidance, it is necessary to ensure that the intended user is fills the IC correctly. Most probably this will require some instructions. Additionally, most manufacturers use symbols on the IC. According to annex I 23.1(h), these symbols must be explained since they cannot be part of harmonised standards or common specifications, because there are no harmonised standards or common specifications, yet.

Long story short, you will need some instructions on how to fill the IC. This can be a leaflet or it can be part of you IFU or it may accompany the device in any other way (if you fulfil the eIFU requirements of 207/2012 it can also be provided via eIFU).

The term "rapid access" as used by EU institutions usually means hard copy/paper form. The term is only used twice in the MDR.
In both cases its about the information to be supplied to the patient with an implanted device, i.e. the patient leaflet.
This requirement is for health institutions in the first place. You should contact your users regarding this, but you could provide instructions on where to find the patient leaflet on your website, make your users print the information in the language required and provide it to the patient.

This way you do not have to include the leaflet in 24 languages.
 
#4
Hello Kat C

The patient implant card is part of your device. To fill the card is part of the workflow during the intended use of the device. Therefore and independent of the guidance, it is necessary to ensure that the intended user is fills the IC correctly. Most probably this will require some instructions. Additionally, most manufacturers use symbols on the IC. According to annex I 23.1(h), these symbols must be explained since they cannot be part of harmonised standards or common specifications, because there are no harmonised standards or common specifications, yet.

Long story short, you will need some instructions on how to fill the IC. This can be a leaflet or it can be part of you IFU or it may accompany the device in any other way (if you fulfil the eIFU requirements of 207/2012 it can also be provided via eIFU).

The term "rapid access" as used by EU institutions usually means hard copy/paper form. The term is only used twice in the MDR.
In both cases its about the information to be supplied to the patient with an implanted device, i.e. the patient leaflet.
This requirement is for health institutions in the first place. You should contact your users regarding this, but you could provide instructions on where to find the patient leaflet on your website, make your users print the information in the language required and provide it to the patient.

This way you do not have to include the leaflet in 24 languages.
Thank you for your feedback, L_O_B! My main concern for the point of this discussion was whether or not we needed a method/location to put a leaflet document in addition to the eIFU up on our website in an eIFU-compliant manner, and your response indicates that including it in the eIFU would be sufficient. You also provided additional information that will be helpful in our implementation plans. I appreciate it!
 
#5
Thank you, dgrainger! That was my understanding, too, but I was particularly concerned with the method it needed to be made available on the manufacturer website (e.g., if it could be part of the IFU). It sounds like offering it as part of the IFU should be acceptable.
 
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