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  • 1.  Post Market Surveillance for MDD Device IIa vs MDR Quality Plan

    This message was posted by a user wishing to remain anonymous
    Posted 08-Feb-2021 08:23
    This message was posted by a user wishing to remain anonymous

    We have a class IIa device and trying to understand from the following list of items (currently before the MDR date of application - May 26, 2021) what falls under MDD, after the date of application for the next year or so until we get our MDR approval and what falls under our future MDR quality plan while we are in that transition til we get our Notified Body review and approval of our Technical Document completed and then also our QMS certified to MDR:

    These are the main elements I know of:
    • PMS plan
    • PMCF plan
    • PMCF Evaluation Report
    • PSUR (Periodic Safety Update report)
    My understanding is I need to have PMS set up so a PMS plan for MDD & MDR.

    The classification doesn't change between the MDD & MDR for the device.  

    The rest of the list would be applicable for the MDR based on my understanding of the MDR per Annex III, Articles 83 - 86 and below references.   

             PMS plan (Annex III, section 1.1; Article 83-84)

            PMCF plan (Part B of Annex XIV)

            PMCF Evaluation Report (Part B of Annex XIV, section 7)

            PSUR (Article 86)

    Please provide feedback.


  • 2.  RE: Post Market Surveillance for MDD Device IIa vs MDR Quality Plan

    Posted 08-Feb-2021 09:55
    From our MDR Plan

    1.1.1               Post Market Clinical Follow-Up

    MDR has additional requirements related to post market clinical follow-up.  A PMCF is required for all devices under unless a justification is able to be provided (as identified in Annex II, section 6.1(d) and Annex III, section 1.1b).

     

    Post market clinical follow-up is a continuous process that updates the clinical evaluation and is addressed in the post-market surveillance plan.  Conducting PMCF involves proactively collecting and evaluating clinical data from the use in or on humans of a device with the CE mark and is placed on the market.  The purpose is to confirm the safety and performance of the device throughout the expected lifetime of the device, of ensuring the continued acceptability of identified risks, and of detecting emerging risks on the basis of factual experience.

     

    The documentation expected for post market clinical follow-up includes a post market clinical follow-up plan and post market clinical evaluation report.

     

    MDR identifies that PMCF is required for all devices, expect where a justification can be provided.

     

    COMPANY believes that for the DEVICE device, a justification can be created as to why PMCF is not necessary.  The justification includes the following reasons:

    • COMPANY's Post-Market Surveillance process is sufficient in collecting post market data and demonstrating safety and effectiveness of the device.
    • COMPANY has performed a clinical evaluation using literature, and continues to perform reviews of literature and publicly available information of similar devices.
    • PRODUCT is not a high risk device, as demonstrated by the risk assessment.
    • The safety and performance of the device has been demonstrated by non-clinical testing, including safety testing, electromagnetic compatibility testing, biocompatibility testing, and performance / bench testing.

     

    COMPANY will document a justification for why a PMCF is not necessary for the DEVICE device and include this within the clinical evaluation.  Throughout the lifecycle of the product, COMPANY will continually evaluate and confirm that this justification is still applicable and that clinical investigations are not necessary. 



    ------------------------------
    Edward Panek
    VP, QA/RA
    Med Device

    DOD/DARPA/Dept Veterans Affairs Design Controls in Research

    Research into Neural Nets - https://www.twitch.tv/edosani
    ------------------------------

    Original Message


  • 3.  RE: Post Market Surveillance for MDD Device IIa vs MDR Quality Plan

    Posted 08-Feb-2021 10:47
    Based on your description it sounds like you are implementing Article 120, because you will not get an MDR CE Mark before May 26, 2021.
    The basic concept is that you can continue to use the MDD CE Mark as long as you implement seven things.

    • No significant change in device design (there is an MDCG guidance document here)
    • No significant change in intend use
    • The MDR PMS system
    • The MDR Market Surveillance system
    • The MDR Vigilance system
    • Register as a manufacturer in Eudamed
    • Register the device in Eudamed (this includes populating the UDI database)

    For PMS you will need a PMS Plan.

    Part of the PMS Plan is a decision on the need for PMCF. If needed the PMS Plan contains the PMCF Plan. Execute the plans and write the appropriate reports.

    Part of the PMS Plan is indicators and thresholds related to benefit-risk. You will need to conduct a benefit-risk determination and document the benefit-risk ratio.

    Part of manufacturer registration includes identifying at least one PRRC.

    Part of device registration includes populating the UDI database. Putting the UDI on the device has a different implementation date.

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


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