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  • 1.  MDR Article 18 - Implant Cards

    This message was posted by a user wishing to remain anonymous
    Posted 22-May-2018 08:54
    This message was posted by a user wishing to remain anonymous

    Hello All,

    Any advice regarding implant cards please?

    We are manufacturing sports medicine implants (non serialised), our current plan is to include a folded to creditcard sized implant card which would include in English :
    - The device name, the device model
    - Name, address and the website of the manufacturer
    A sticker would be applied which would contain the lot number and UDI (note: no serial number)

    The website would then contain, in multiple languages:
    - Any warnings, precautions or measures to be taken by the patient or a healthcare professional
    - Any information about the expected lifetime of the device and any necessary follow-up

    Does anyone have any other approaches or know if this would be acceptable?

    Many thanks


  • 2.  RE: MDR Article 18 - Implant Cards

    Posted 23-May-2018 07:58
    For the website you didn't list "the overall qualitative and quantitative information on the materials and substances to which patients can be exposed" as required by Article 18 Section 1(d) and Annex I, Section 23.4(u)

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    Dan O'Leary
    Swanzey NH
    United States
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    Original Message


  • 3.  RE: MDR Article 18 - Implant Cards

    Posted 23-May-2018 12:41
    Dear Colleague,

    I believe, that there is no clear answer for this yet. However, taking into consideration the principles of the EUMDR "a high level of protection of health for patients and users, … high standards of quality and safety for medical devices in order to meet common safety concerns as regards such products" probably right solution may be found.

    What is for sure, "..the manufacturer shall provide the information referred to in point (a) of the first subparagraph on an implant card delivered with the device."

    My understanding is, that in case the website may meet the requirement "..means that allow rapid access to that information …" it may be used.

    However, it is also stated in Article 18, "Member States shall require health institutions to make the information referred to in paragraph 1 available, by any means that allow rapid access to that information, to any patients who have been implanted with the device, together with the implant card, which shall bear their identity."
    So, probably from the health care facility (customer) point of view, paper-based information in the secondary packaging would be better.
    The requirement in Annex I. 23.4 (s) "information that allows the user and/or patient to be informed of any warnings, precautions, contra- indications, measures to be taken and limitations of use regarding the device. That information shall, where relevant, allow the user to brief the patient about any warnings, precautions, contra-indications, measures to be taken and limitations of use regarding the device…" might be understood as a Patient Information Leaflet (similarly to the medicines).

    Probably, you also need to consider the difficulties of the introduction of the e-IFU (Commission Regulation No. 207/2012).

    So, I think - putting all this together - I would not exclude the paper-based information.

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    Peter Mikó M.D
    ArtPharm Ltd.
    Gyermely
    Hungary
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    Original Message


  • 4.  RE: MDR Article 18 - Implant Cards

    Posted 09-Oct-2018 23:35
    Per Article 18 of MDR, it states that the following implants are exempt from the requirement of a patient implant card: sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, and connectors.


    Can anyone provide similar guidance for requirements for FDA patient card and/or exemptions?

    Thanks

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    Kevin
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    Original Message


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