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  • 1.  Question About EUDAMED SRN

    Posted 24-Sep-2021 08:13
    Hi-
    Is anyone having issues with EUDAMED Actor registration through the EUDAMED portal? What is the best way to get an update on status of registration for Actor “Manufacturer” other than the email communication to EUDAMED support email provided through the portal & email to competent authority?
    Any help with this is greatly appreciated.

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    Ritam Priya
    VP Quality & Regulatory

    Fremont CA
    United States
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  • 2.  RE: Question About EUDAMED SRN

    Posted 24-Sep-2021 22:42
    Hi Ritam

    Earlier this year it was taking three to six weeks, depending on where your authorised representative is located.

    (There was a thread titled "Eudamed actor registrstion module")

    The verification step for foreign actors is manual, so it gets done as they have time. Then one day you log in and your new SRN has appeared.

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    Anne LeBlanc
    United States
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    Original Message


  • 3.  RE: Question About EUDAMED SRN

    Posted 25-Sep-2021 04:24
      |   view attached
    Hey Ritam
    Maybe the attached document released recently will help you?
    Best
    Ella

    ------------------------------
    Ella Sheiman
    Haifa
    Israel
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    Attachment(s)

    pdf
    EUDAMED actors module.pdf   85 KB 1 version
    Original Message


  • 4.  RE: Question About EUDAMED SRN

    Posted 28-Sep-2021 04:35
    Hi,

    do you know if registration of manufacturers is mandatory or not?
    Our notified body requires us the SRN to certify new devices according to EU MDR...

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    Andrea Duca
    Roma
    Italy
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    Original Message


  • 5.  RE: Question About EUDAMED SRN

    Posted 28-Sep-2021 08:07
    Hi Andrea

    My understanding is device manufacturer registration is not legally enforced before the "fully functional" stage of EUDAMED implementation. But notified bodies can require it in advance, because there's no way they could update all the certifications at once when it becomes mandatory.

    https://ec.europa.eu/health/md_eudamed/actors_registration_en

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    Anne LeBlanc
    United States
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    Original Message


  • 6.  RE: Question About EUDAMED SRN

    Posted 28-Sep-2021 08:34
    I tested our Eudamed documentation prior to engaging our MDR Rep and my submission was rejected (as expected) as we have not engaged our MDD rep as our MDR rep yet. That happened in about 2 days. Once we have our MDR submission ready, we plan to resubmit after contracting our MDD Rep as our MDR rep and I think it should be ok.

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    Edward Panek
    VP, QA/RA
    Med Device
    USN Veteran
    Research into Neural Nets - https://www.twitch.tv/edosani
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    Original Message


  • 7.  RE: Question About EUDAMED SRN

    Posted 28-Sep-2021 09:11
    Article 31(3) says, "The manufacturer shall use the SRN when applying to a notified body for conformity assessment and for accessing Eudamed in order to fulfil its obligations under Article 29".

    You should obtain an SRN, now that the Eudamed module is functional, to use as part of the application process.

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


  • 8.  RE: Question About EUDAMED SRN

    Posted 28-Sep-2021 11:54
    Edited by Kevin Randall 28-Sep-2021 12:22
    Article 31 (e.g., registration of manufacturers and obtaining an SRN) is in abeyance until at least 6 months after the Commission's yet-to-be published Article 34(3) notice of full EUDAMED functionality.  Indeed, the Commission has stated, "...The Commission is not in a position to require the use of the Actor registration module until EUDAMED is fully functional..."  This is pursuant to EU MDR Article 123(d), first paragraph, second hash.

    I certainly recommend voluntarily obtaining your SRN as soon as possible.  That said, if an NB demands an SRN at this time, then it is doing so in contravention of the associated legislative requirements clearly spelled out by the EU MDR.  There are no grounds for such an NB demand unless you've signed a contractual agreement with the NB surrendering your legislative rights on the matter.

    I would definitely engage the NB on its prohibited stance, especially if it is holding your certification hostage over the matter.  My guess is that the NB knows better, and I wonder if the NB is just stalling due to lack of bandwidth.

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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


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