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  • 1.  Question on MDR Remediation involving PSUR

    Posted 25-Jul-2018 17:17
    Edited by Vadivelan Dharanisingh 25-Jul-2018 17:20
    ​Hi,

    This question is regarding the MDR 745/2017 PSUR requirement.

    When we are approaching for the MDR CE certification for a medical device (ClassIIb) which is already certified under MDD, do we need to submit the completed PSUR to Notified body,

    This question arised because the Quality system of the company might be updated with MDR points by 2019 and without the procedure or documents  it would be not possible to carry out the PSUR for a product.

    Or  will the notified body can ask  PSUR for the year 2019 for the medical device, Please share your comments.




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    Vadivelan Dharanisingh
    Product Regulatoy Lead
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  • 2.  RE: Question on MDR Remediation involving PSUR

    Posted 26-Jul-2018 04:43
    ​Dear Vadivelan,
    The PSUR is due at the latest one year after MDR certification (for class III and IIb).

    However,  for class III and IIb devices that remain on an MDD certificate after the date of application (26 May 2020), the PSUR is due one year after 26 May 2020. This is because the PSUR, like other PMS obligations, will become effective on 26 May 2020 for all devices on the market regardless of the certification (MDR or MDD). 

    If you have class IIa devices, the PSUR is due "when necessary" and at the latest 2 years after certification, or two years after 26 May 2020 for medical devices still under an MDD certificate after the date of application.

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    Andrea Sparti
    Regulatory Affairs Manager
    Bienne
    Switzerland
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    Original Message


  • 3.  RE: Question on MDR Remediation involving PSUR

    Posted 26-Jul-2018 06:21
    I would also argue that a "PSUR" type of document needs to start being created now, because the Medical Device Regulation "entry into force" was 25 May 2017.  Entry into force means that companies need to start complying with appropriate requirements.  While there is no format, template, or method to upload PSUR into an electronic system, there is still enough information in the Articles and Annex III as to what should be included in a PSUR.  Recommendation: start gathering data now, analyse, and summarise.

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    Richard Vincins RAC
    Vice President Regulatory Affairs
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    Original Message


  • 4.  RE: Question on MDR Remediation involving PSUR

    Posted 26-Jul-2018 07:15

    The original question asked whether the company needs to submit the completed PSUR as part of the application for CE Mark. Since this is a Class IIb device, I infer the manufacturer will follow the conformity assessment path in Annex IX. The Annex does not require a completed PSUR as part of the application.

    Annex IX does require the QMS documentation be in place, so the procedures for creating the PSUR should have been issued. Use CEN/TR 17233:2018 to understand how to map the requirements from Article 10 Section 9 to Annex IX.

    The manufacturer of a Class IIb device updates the PSUR annually. The PSUR includes analysis of the PMS data collected from the PMS plan. Presumably, the PMS plan must have been in operation collecting information as an input to the PSUR.

    To update the PSUR implies there must have been an initial PSUR and then subsequent changes. My recommendation is to make the initial PSUR with the information required in Article 86(1c) and mark the other required sections as TBD. Prepare the initial version immediately after the implementing the procedure.

    Remember that you can implement all the requirements of the MDR today. You do not need to wait. I don't believe that any of the QMS requirements in Article 10 contradict anything in the MDD. They just add additional requirements.



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    Dan O'Leary
    Swanzey NH
    United States
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    Original Message


  • 5.  RE: Question on MDR Remediation involving PSUR

    Posted 26-Jul-2018 13:44
    ​Hi Andrea Sparti/Richard Vincins/Dan O'Leary,

    Thank you all for your immediate response and for your valid inputs.



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    Vadivelan Dharanisingh
    Product Regulatoy Lead
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    Original Message


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