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  • 1.  SSP reference in IFU

    Posted 10-Jan-2022 09:09
    Dear Forum members,
    I have a question regarding SSP and IFU. For our IVD (class C) we have prepared an SSP and shared with the NB that has accepted/validated the document. However, according to IVDR requirements labelling and/or IFU shall indicate where in EUDAMED the SSP can be found.

    For class C and D devices, other than devices for performance studies, the manufacturer shall draw up a summary of safety and performance.
    The summary of safety and performance shall be written in a way that is clear to the intended user and, if relevant, to the patient and shall be made available to the public via Eudamed.

    The draft of the summary of safety and performance shall be part of the documentation to be submitted to the notified body involved in the conformity assessment pursuant to Article 48 and shall be validated by that body. After its validation, the notified body shall upload the summary to Eudamed. The manufacturer shall mention on the label or instructions for use where the summary is available.


    We have not yet registered the company in EUDAMED, so how shall such a statement be  written in the mean time?
    Could we make it available on our company website and reference this location or must it absolutely be EUDAMED?
    Could we say in the IFU:
    "The SSP will be made available in EUDAMED as soon it's fully functional". or
    "The SSP is available under at www.XYZ.com/SSP".

    Do you have any insights, how the EUDAMED location has to be defined/identified?

    Thanks in advance for your help.

    Enrico


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    Le Mont-sur-Lausanne
    Switzerland
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  • 2.  RE: SSP reference in IFU

    Posted 11-Jan-2022 02:52
    Hi Enrico,

    this requirement can´t be fulfilled at this point in time. There is no obligation for the manufacturer to actually upload and you need to get the reference link from your Notified Body. I just have experience with one Notified Body who stated that they think about creating an own database (certainly paid by their clients) and then providing a reference to the manufacturer. I would consider getting in touch with your Notified Body as solutions for this gap may be different.

    All the Best

    Markus

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    Markus Lantermann
    Head of Q&R Region International
    Mannheim
    Germany
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    Original Message


  • 3.  RE: SSP reference in IFU

    Posted 11-Jan-2022 04:32
    Hello Enrico,

    As Markus stated this is not functional yet and not yet even on a voluntary basis.  I completely agree with him you should reach out to your Notified Body on how they want to currently address the "public availability" of the Summary of Safety and Performance (SSP) for your IVD medical device.  As an example, in the medical device area of EU MDR, I know companies who have worked with their Notified Body to have their Summary of Clinical Safety and Performance (SSCP) on the company's own website.  Then in the IFU instead of providing link to EUDAMED location, for now it is publicly available on the Internet through the company's website.  I would also add the disclaimer statement the SSP will be available on EUDAMED once fully functional.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


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