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  • 1.  No need for SSCP justification

    Posted 19-Jan-2022 05:19
    Dear friends

    Recently we had a comment from an auditor asking us to add justification of why we have no need to follow requirements for SSCP. The product is IIa device- not implantable, not class III. He haven't wrote it officially or issued it as an official comment or NC.

    I also heard some mentioning of this in the BSI webinar regarding Clinical Evaluation and PMS under the MDR.

    Did someone here also encountered such request?

    Thank you
    Ella

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    Ella Sheiman
    Haifa
    Israel
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  • 2.  RE: No need for SSCP justification

    Posted 20-Jan-2022 03:19
    Edited by Richard Vincins 20-Jan-2022 04:05
    Hello Ella,

    Not to be blunt but tell the auditor they are not doing it right.  The EU MDR is very clear on what products require a Summary for Safety and Clinical Performance (SSCP).  If companies, especially Class I or Class IIa devices, had to write justification or rationale for every single item that did not need to be done, there would be so much extraneous information.  With that said, I have to admit we have many entries in Technical Documentation, risk management planning, clinical evaluations, etc., where we have statements about why we do not do something or have justifications.  It is silly really, but a world we work in.

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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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  • 3.  RE: No need for SSCP justification

    Posted 20-Jan-2022 07:37
    Thank you
    I was surprised also, but when I heard something that sound like that during BSI webinar that raised some warning lights and I decided to check it out here :)

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    Ella Sheiman
    Haifa
    Israel
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  • 4.  RE: No need for SSCP justification

    This message was posted by a user wishing to remain anonymous
    Posted 20-Jan-2022 13:58
    This message was posted by a user wishing to remain anonymous

    Hi Ella, 

    When the auditor asked us about the SSCP I replied that it was not applicable to us according to Article 32, since our product was also Class IIa non-implantable. He made a note of that at that moment, and then he asked me to repeat it later on.

    If a document/requirement is not applicable to the classification of your device, just be firm saying it is not applicable. Some requirements may need justification if it is in the fence of applicability, but something as clear as this, should not be necesary.

    Good luck, 

    A