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  • 1.  PSUR (Periodic Safety Update Report)

    Posted 23-Sep-2021 16:20
    Dear Community,

    I have questions about PSUR required for medical devices.

    How and where this report should be submitted?
    Also, I am wondering if anyone knows about a complete and acceptable PSUR template?

    Any feedback is appreciated.

    Thanks,
    Fateme

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    FATEME FARMAD
    Quality and Regulatory Affairs Associate
    Minnetonka MN
    United States
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  • 2.  RE: PSUR (Periodic Safety Update Report)

    Posted 23-Sep-2021 17:28
    Edited by Kevin Randall 23-Sep-2021 17:38
    For EU MDR PSURs:

    • Update Class IIa device PSURs at least every two years.  Make them available to the Notified Body (NB) as part of the conformity assessment process (meaning that EUDAMED or other real-time submission is not required by the EU MDR, yet the NB may devise its own unique contractual requirement), and, upon request, to competent authorities.

    • Update Class IIb and III device PSURs at least annually. Make them available to the Notified Body as part of the conformity assessment process (meaning that EUDAMED or other real-time is not required by the EU MDR, yet the NB may devise its own unique contractual requirement), and, upon request, to competent authorities.

    • Any time a class III implantable device PSUR is updated, submit to the Notified Body the updated PSUR via EUDAMED (once available) or in the way the Notified Body instructs in the meantime.


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      Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
      Principal Consultant
      Ridgway, CO
      United States
      © Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
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      Original Message


    • 3.  RE: PSUR (Periodic Safety Update Report)

      Posted 24-Sep-2021 03:30
      For Eudamed, currently even only the actor module is live, so submission to Eudamed, even the listing of devices is not yet possible

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      Franky Dubois
      QA/RA Manager
      Gent
      Belgium
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      Original Message


    • 4.  RE: PSUR (Periodic Safety Update Report)

      Posted 24-Sep-2021 05:11
      Hello Fateme,

      Keep in mind the Entry into Force of the EU MDR regulation was May 2017 and compliance date May 2021 (with one year delay).  The PSUR should already starting to be worked on and even published.  At a minimum there should be a PMS Plan published.  Depending on class and type of device then a PSUR would be published.  Note also the regulation uses wording like as necessary, so the review and update period needs to be according to type and risk of device.

      As Kevin mentioned, these need to be available during your Notified Body audit.  Certain classes will need to be uploaded to an electronic system (EUDAMED) in the future when this is fully functional.  Do not get stuck in a bad discussion or nonconformity because this is already not available, as might be the expectation during your EU MDR QMS audit.

      For a template, there are a few out there - maybe contact a consulting company to help or obtain a sample from a friend.  There is supposed to be a guidance document published, but do not wait for that.  Also you can reference ISO/TR 20416 for some ideas and thoughts on contact of PSUR.  And of course, it is detailed in Annex III what is contained in the report, but with any regulation there is further interpretation of what also should be included.

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      Richard Vincins RAC
      Vice President Global Regulatory Affairs
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      Original Message


    • 5.  RE: PSUR (Periodic Safety Update Report)

      Posted 24-Sep-2021 23:13
      Edited by FATEME FARMAD 24-Sep-2021 23:20


    • 6.  RE: PSUR (Periodic Safety Update Report)

      Posted 24-Sep-2021 10:48

      EU-MDR Article 86 provides the details. The answer depends on the device class and other attributes. There are characteristics to consider but the revelent ones here are update frequency, transmission method, and storage.

       

      Class IIa
      Update frequency: At least every two years
      Transmission: Hold for the NB to review during an audit
      Storage: Retain a copy in the Annex II documentation and in the Annex III documentation

       

      Class IIb
      Update frequency: At least annually
      Transmission: Hold for the NB to review during an audit
      Storage: Retain a copy in the Annex II documentation and in the Annex III documentation

       

      Class III
      Update frequency: At least annually
      Transmission: Submit to the NB through Eudamed
      Storage: Retain a copy in the Annex II documentation and in the Annex III documentation

       

      Custom made device
      Update frequency: At per the class
      Transmission: As per the class
      Storage: Retain a copy in the Annex XIII Section 2 documentation

       

      Implantable device
      Update frequency: At per the class
      Transmission: Submit to the NB through Eudamed
      Storage: Retain a copy in the Annex II documentation and in the Annex III documentation



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


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