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PSUR

  • 1.  PSUR

    This message was posted by a user wishing to remain anonymous
    Posted 14-Sep-2023 09:17
    This message was posted by a user wishing to remain anonymous

    Dear Forum SMEs,

    For a Class IIb non-implantable device, I greatly appreciate your advice to bring the PSUR into compliance.

    Here is the situation:

    1. missing a PSUR for 2021
    2. having a PSUR for 2022 (Jan. 2022 to Dec. 2022)

    We're updating our PSUR template following MDCG 2022-21. Can we write a report for the legacy device to cover the time range from Jan. 2023 to Dec. 2023? Do we have to cover May 26, 2021 to Dec. 2021?

    Thank you!!



  • 2.  RE: PSUR

    Posted 15-Sep-2023 06:24

    Hello Anon,

    First you should have a Post Market Surveillance Plan (PMS Plan or PMSP) describing what you are going to do, how it will be done, etc.  This should have been started back in May 2021 or earlier, but you are probably aware of that point.  Therefore, write a PMS Plan from a "retrospective" view going back, which could go back just to May 2021, but that would not be advisable.  If the Class IIb non-implant device was already on the market, there should be existing post market data which should be incorporated to address other points in the EU MDR like risk management, change control, trending, etc.  So the PMS Plan can apply not only back to 2021, but even maybe 2016 (5 years is decent to go back for trending) or when the product was placed on the market.  A PSUR can then be "published" now covering back to 2021/2016 up to current point in time.  Or could also publish a PSUR now, covering the time period up to 2022.  Then publish another PSUR now (shortly after), for up to current time period in 2023.  (As mentioned you could publish one now for everything up to Dec 2022 and then publish one in December 2023.)  Then the PMS Plan should be updated/revised as necessary moving forward which would then be for the PSUR that would be published in 2024.  And so on.



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

    Original Message


  • 3.  RE: PSUR

    Posted 16-Sep-2023 06:36

    Dear Anon,

    Please examine the conditions of Section 5 of MDCG 2022-21 to check where your case falls under. 

    Based on the following text, I would cover minimum from 26. May 2021 onwards. Covering one year prior may be of benefit to demonstrate continual/ consistency of event report count / severity of event.

    Following taken from Section 5.1 of MDCG 2022-21

    5.1 Data collection period, issuance timeline, submission and schedule of PSURs

    The data collection period should start at the device MDR certification date. If the device is not MDR-certified, the data collection period starts at MDR Date of Application (26 May 2021).

    Note 1: for the first PSUR, the data analysis may be supported by the device's historical data collected through the Post Market Surveillance activities as they were conducted prior to Date of Application or MDR Device Certification date (see section 5.2.2.1).

    Note 2: The first PSUR may not cover an exact data collection period of 12 or 24 months. The first PSUR update(s) may then cover a period different than 12 or 24 months of post- market data to allow for data collection periods being contiguous to avoid any gap or overlap of data, i.e. the end of data collection period for one PSUR marks the start date of the next PSUR's data collection period.



    ------------------------------
    Stephanie Grassmann
    Founder & Managing Director of MedTechXperts Ltd
    Biberstein
    Switzerland
    ------------------------------

    Original Message


  • 4.  RE: PSUR

    Posted 18-Sep-2023 18:11

    Thank you so much for your replies!
    We had a plan for 2021. however, we missed the PSUR report for 2021. The regular data collection period for our PSUR is Jan. to Dec. of each year. Following MDCG 2022-21, the data collection period starts at the DoA (May 26, 2021); we want to know how to fill the half-year gap. 
    For clarification, we had PSURs in 2019, 2020, and 2021 as a legacy device.
    Can we write a PSUR for 2023 from Jan. to Dec. of this year, or do we have to go back to write a PSUR from May 26, 2021, to May 2022, then another one from May 2022 to May 2023?

    I very much appreciate your advice!

    All the best.



    ------------------------------
    Dawn Li
    Principal RA specialist
    Corcoran MN
    United States
    ------------------------------

    Original Message


  • 5.  RE: PSUR

    Posted 19-Sep-2023 10:06

    Hi Dawn,

    could you elaborate what you mean by "we had PSURs in 2019, 2020, and 2021 as a legacy device"?

    Do you have a class IIb device that was MDD-certified and then transitioned to MDR-certification in 2021? And if yes, were there significant changes made for this transition or is it essentially the same device? And died the 2021 PSUR cover Jan. to Dec.?

    At least for me this would be important to know, to give you an opinion on how to proceed.

    Best regards

    Christoph



    ------------------------------
    Christoph Kiesselbach
    Reutlingen
    Germany
    ------------------------------

    Original Message


  • 6.  RE: PSUR

    Posted 19-Sep-2023 21:14
    Hi Christopher,
    Yes, it is an MDD-certified device, but will not be MDR-certified until 2027.
    There have been no significant changes. Due to the organization changes, the PSUR was missed for 2021.
    Thanks,
    Dawn

    Sent from my iPhone


    Original Message


  • 7.  RE: PSUR

    Posted 20-Sep-2023 07:53

    Hi Dawn,

    thank you for the clarification.

    One follow-up question: You said in your previous post that you "had PSURs in 2019, 2020, and 2021 as a legacy device". Is this a different legacy device? Or does the 2021 PSUR only cover from January to May?

    Thanks,

    Christoph



    ------------------------------
    Christoph Kiesselbach
    Reutlingen
    Germany
    ------------------------------

    Original Message


  • 8.  RE: PSUR

    Posted 20-Sep-2023 08:53
    Hi Christoph,
    It’s the same device. We had PSUR reports for 2019, 2020, and 2022. For 2021, we had PMS plan but missed the report. Following the MDCG, the PMS data should start from the MDR DoA (May 26 2021).
    Our normal data collection was Jan. to Dec. of each year. For 2023 should we do as usual, or should we go back to do May 2021 - May 2022 and May 2022 - May 2023? How to fill the half year gap?

    Thanks for your help!
    Best regards,
    Dawn




    Sent from my iPhone


    Original Message


  • 9.  RE: PSUR

    Posted 20-Sep-2023 11:00

    Hi Dawn,

    thanks for the clarification.

    From my point of view there is no need to adapt the data collection / evaluation / reporting period for 2021 if you already had an ongoing annual schedule. The formal requirement to start with PMS activities according to the MDR for legacy devices started May 26 2021, but as far as I can see there is no provision in the MDR that stops you from starting earlier (and I do not think that is what the MDCG Guidance aims at).

    So my proposal would be to retrospectively generate a PSUR for 2021 covering Jan-Dec as planned and be transparent within the document that is was generated as a correction for a nonconformity. You need the respective data anyway because I assume they will be part of the 2023 PSUR (that includes data from the previous years). For 2023 you can then proceed as planned, covering again Jan. to Dec. (including the data from 2021 and without having an artificial split in your data analysis in 2021).

    In addition to this correction you will need to think about corrective and preventive actions to make sure that in the future you do not miss the PSUR creation (and maybe see if there are other required activities or documents that could be affected by similar problems). An important question for this from my point of view would be if you just missed the creation of the PSUR – summarizing the data you created during your planned PMS activities – or if some of the planned data analyses or corresponding evaluations were not performed. I would view the latter case as more critical, requiring more detailed analysis and actions.

    As a side note: Was this nonconformity detected by your notified body? In theory you should have had at least one surveillance audit where the 2021 PSUR should have been a topic.

    Best regards

    Christoph



    ------------------------------
    Christoph Kiesselbach
    Reutlingen
    Germany
    ------------------------------

    Original Message


  • 10.  RE: PSUR

    Posted 19-Sep-2023 21:20
    Sent from my iPhone


    Original Message


  • 11.  RE: PSUR

    Posted 20-Sep-2023 11:47

    Hi Christoph,

    If we do a retrospective PSUR for 2021, how would you recommend addressing activities such as literature search, CER, and PMCF? Can we combine those activities in the 2023 report?

    Thanks!

    Dawn



    ------------------------------
    Dawn Li
    Principal RA specialist
    Corcoran MN
    United States
    ------------------------------

    Original Message


  • 12.  RE: PSUR

    Posted 20-Sep-2023 12:29

    Hi Dawn,

    this goes back to my question about the scope of the problem: Were literature search and PMCF activities performed as scheduled and just not summarized in a PSUR or were they not performed at all? A lot depends on the details of how your PMS process and PSUR is structured and is difficult to answer without more time and information.

    I still think it would make sense to have some kind of retrospective PSUR for 2021, just to make sure that someone looking for it can find the document, even if it refers to the 2023 PSUR for some details where a retrospective analysis makes no sense. But again this is difficult to say without more detailed information.

    If you like, you can contact me under kiesselbach@schrack-partner.eu, that would probably a better way to discuss this than writing in this forum.

    Best regards

    Christoph



    ------------------------------
    Christoph Kiesselbach
    Reutlingen
    Germany
    ------------------------------

    Original Message


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