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  • 1.  Article 18- First in Man-- Implant card and Patient Information Guide/Leaflet

    Posted 16-Jun-2023 08:06

    I am hoping someone could help me out here. 

    If we would like to conduct a First in Man study in the EU for an implantable device, after the procedure, do we need to provide the patient with a Implant Card AND a Patient Information Leaflet/Guide?

    Or is this only required once the device is MDR / CE approved and on the market?

    Please advise.



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    Jan Flegeau
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  • 2.  RE: Article 18- First in Man-- Implant card and Patient Information Guide/Leaflet

    Posted 16-Jun-2023 11:37

    The requirement to provide an Implant Card and Patient Information Leaflet/Guide to patients after a First in Man study in the EU may not be applicable for investigational devices that are not yet MDR/CE approved and on the market.

    Typically, the requirement for providing these documents to patients comes into effect once the device has received CE marking and is commercially available. The Implant Card and Patient Information Leaflet/Guide are intended for post-market use to ensure patient safety and informed use of the device.



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    Raje Devanathan
    Amerisource Bergen
    TPIreg, Innomar Strategies
    Senior Manager - Regulatory Affairs, Medical Devices
    rdevanathan@tpireg.com
    3470 Superior Court
    Oakville ON L6L0C4
    Canada
    ------------------------------

    Original Message


  • 3.  RE: Article 18- First in Man-- Implant card and Patient Information Guide/Leaflet

    Posted 17-Jun-2023 03:27

    Hello Jan,

    Providing an implant card for a first in person study is not necessarily required as this would fall under the investigational device requirements in Annex XV.  As part of the clinical investigation, the subjects are given Informed Consent which they have a copy so they should get information about the device, what it does, risks, etc.  Though, they would not receive necessarily specific information about the device, I have seen Ethics Committee want this information provided if the device is an implant ... well because it is an implant going to be in someone's body for a long time.  When working with these type of studies, we would provide a type of implant card (not necessarily according to Article 18) already to those patients so they had the information available.  Again, some of the information would be in the Informed Consent already.



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 4.  RE: Article 18- First in Man-- Implant card and Patient Information Guide/Leaflet

    This message was posted by a user wishing to remain anonymous
    Posted 20-Jun-2023 09:13
    This message was posted by a user wishing to remain anonymous

    If you're implanting them in live patients, the patients will probably want to have relevant information about them.


    Original Message


  • 5.  RE: Article 18- First in Man-- Implant card and Patient Information Guide/Leaflet

    Posted 18-Jun-2023 06:12

    As already mentioned by others: the Article 18 implant card only applies for MDR certified devices. However, as part of the study requirements you must inform the patient. And guess what: part of that information covers most data elements of the implant card. The main differences with the implant card are in the formalities. 

    Having said that, I still would consider issuing an implant card, without calling it that. In that way, you don't have all the formal requirements that go with the implant card, and which may be extremely complex to manage for an investigational device, but you still get the opportunity to practice with the concept of the implant card. In that way you have already hands-on experience by the time you have to do this for real. 



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    Ronald Boumans
    MDR Expert
    Super PRRC
    Netherlands
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    Original Message


  • 6.  RE: Article 18- First in Man-- Implant card and Patient Information Guide/Leaflet

    Posted 19-Jun-2023 11:57

    Hi Jan - happy to see you here! :)

    To add to this discussion, our experience was that even pre-MDR, some competent authorities were requiring implant cards for implantable devices in clinical studies. It was years ago, but I want to say this included Germany and Italy, maybe others. It would be worth looking into whether there are still any local requirements in your countries of interest above those in MDR. 

    As others have said, the device will be in patients' bodies permanently, so whether or not it's in a study and regardless of the requirements it's good practice to have something for your patients to keep to inform their providers about the implant, particularly if there's any chance of interference (e.g., MRI). The MDCG 2019-8 guidance is very helpful in laying out the format and content of the implant card, so it's not hard to develop one; the hardest part is the logistics of printing and inserting into the package (and of course, ensuring your packaging testing supports the extra paper in the package). 

    Good luck! 

    Jennifer



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    Jennifer Cabralda RAC
    Director, Regulatory Affairs
    Coquitlam BC
    Canada
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    Original Message


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