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.
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.