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  • 1.  PSUR (MDCG 2022-21)

    This message was posted by a user wishing to remain anonymous
    Posted 22-Jan-2024 15:30
    This message was posted by a user wishing to remain anonymous

    Dear RAPS,

    According to MDCG2022-21 section 2 " How Data Should be assessed by the manufacturer" (page 33)  - " The manufacturer should assess the data in relation to the thresholds concerning known risks and side effects and benefits intended to be gained." Does it mean the acceptable/unacceptable risk level or something else? Is it necessary to define the thresholds? 

    Thank you for sharing your experience in dealing with the above!



  • 2.  RE: PSUR (MDCG 2022-21)

    Posted 22-Jan-2024 20:59

    The requirement comes from Annex III(1)(b)(3rd indent), "suitable indicators and threshold values that shall be used in the continuous reassessment of the benefit-risk analysis and of the risk management as referred to in Section 3 of Annex I".



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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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    Original Message


  • 3.  RE: PSUR (MDCG 2022-21)

    Posted 23-Jan-2024 06:10

    Hello Anon,

    The simple answer to your question is yes and yes.  It is of course much more complicated and multi-faceted because the risks, residual risks, side effect, (clinical) benefits, and the acceptable benefit-risk analysis need to be performed.  This needs to look at the risk management file and data being gathered through Post Market Surveillance (PMS).  Also needs to look at the risk management file and published data about the device types.  And so on.  These thresholds need to be defined for the post market data - what is "normal", what is trending, and what are identified items to review.  These then should be linked to the risk management for the type of risk and complaints being received.  It can get a bit complicated, especially depending on the device type.



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
    Oriel STAT A MATRIX - ENTERPRISE
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    Original Message


  • 4.  RE: PSUR (MDCG 2022-21)

    Posted 23-Jan-2024 07:08

    Hi Anon,

    as Dan and Richard point out this is something that goes back to your risk management and clinical evaluation.

    In my opinion it is also not a genuinely new requirement of the MDR but goes back to the general principles of keeping your risk management and clinical evaluation up to date with information you collect post production.

    One additional point: Evaluation and assessment of the data should be an continously running process and not tied to the creation of the PSUR. The PSUR summarizes the results and conclusions of this ongoing activities, but does not necessarily create new results (although you might use the aggregated data for additional analyses, but this would still be part of your planned PMS activities (in accordance with the needs of your device), not something you do specifically for the creation of the PSUR). The guidance from my point of view sometimes does not a good job to point out the difference between PMS activities and collecting and summarising the information in the PSUR.

    Best regards

    Christoph



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    Christoph Kiesselbach
    Schrack & Partner
    Reutlingen
    Germany
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    Original Message


  • 5.  RE: PSUR (MDCG 2022-21)

    Posted 23-Jan-2024 09:15

    Hello - 

    It may be useful to appreciate that the purpose of "data assessment" is to detect potential safety signals that might adversely affect the overall benefit-risk ratio if not addressed in a timely manner. 

    I know your question pertains to the PSUR, but I think it is important to also understand the "Why".

    One of the (mis)interpretations of these requirements, at least in my opinion, is that we seem to think of a quantitative threshold as a way to detect safety signals associated with known/potential risks.

    It is necessary, but not sufficient.

    The clinical context matters. 

    In my experience, the SNIP framework has been very effective in identifying and analyzing potential safety signals. 

    Please reach out if you would like to learn more.

    Best regards



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    Naveen Agarwal, Ph.D.
    Problem Solver | Knowledge Sharer.
    Let's Talk Risk!
    @https://naveenagarwalphd.substack.com/
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    Original Message


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