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  • 1.  EU MDR Application submission Deadline

    This message was posted by a user wishing to remain anonymous
    Posted 12 days ago
    This message was posted by a user wishing to remain anonymous

    I have a question about the EUMDR Application submission deadline. Is there any specific date for the application to Notified Body?



  • 2.  RE: EU MDR Application submission Deadline

    Posted 11 days ago
    Edited by Ilkka Juuso 11 days ago

    Yes. 26th of May this year. That is just a month away, so you should definitely act now if your devices are not yet in the EU MDR. Make contact, get the application forms, sign, and submit. Some details you can add later, but if you don't submit an application now it's game over according to current knowledge.

    With the notified body SGS you can start the conversation by sending a free-form email to: nbmed.fimko@sgs.com

    The best of luck with your application!



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    Ilkka Juuso

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    Original Message


  • 3.  RE: EU MDR Application submission Deadline

    Posted 11 days ago

    I would say, that was about three months ago. The official deadline is on 26 May 2024, but the process to get there takes about four months. And even then, you should know what to expect in this process. If you want to get a smart consultant helping, don't ask me. For this work, I am at full capacity at this moment. 

    After 26 May, you may need a switch to Plan B. I may have time to help two or three clients, so hurry if you need help with that. 



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    Ronald Boumans
    MDR Expert
    Super PRRC
    Netherlands
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    Original Message


  • 4.  RE: EU MDR Application submission Deadline

    Posted 10 days ago

    Anon,

    I agree with the other responses.  You need to move fast, and I would get some help from a consultant.

    Regards,



    ------------------------------
    Mark Schenk
    Principal Consultant
    Sinking Spring PA
    United States
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    Original Message


  • 5.  RE: EU MDR Application submission Deadline

    Posted 10 days ago

    If you're talking about a 'submission deadline' I assume you have a legacy device where the conformity assessment was made under directive 92/42/EEC and you did profit of the transitional provisions of Regulation (EU) 2017/745 (MDR), Article 120. If this is not the case - meaning it is a new product - then, there is no submission deadline.

    If it is legacy device, then you definitely need to hurry!

    Have a look at my LinkedIn post where I've summarized the requirements and uploaded a flowchart that helps you determine if your eligible to still make a submission for your legacy device: https://www.linkedin.com/posts/rchristinger_flowchart-regulation-eu-2023607-conditions-activity-7180951052991569921-a0HS?

    To recap, you need to fulfil the following:

    1️⃣ Your legacy device(s) continue to comply with the MDD / AIMDD
    2️⃣ Surveillance for the legacy devices by your notified body is in place
    3️⃣ No significant changes are allowed to legacy devices (MDCG 2020-3)
    4️⃣ Your legacy devices do not present an unacceptable risk
    5️⃣ Your Quality Management System complies with MDR Art. 10(9)
    6️⃣ You lodged a formal application for a MDR conformity assessment
    7️⃣ An agreement for a MDR conformity assessment is signed by 26 Sep 2024



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    Roger Christinger
    Lead RA/QM Consultant, RAC-Devices
    Zühlke Group, Switzerland

    https://www.zuehlke.com/en/industries/medical-device-healthcare
    ------------------------------

    Original Message


  • 6.  RE: EU MDR Application submission Deadline

    Posted 9 days ago

    Dear Anon,

    I agree with the other responses here, you need to move fast. Mr. Christingers flowchart explains the situation for legacy devices beautifully, thank you for your work there, mr. Christinger!

    If you are interested in help preparing your submission, you can always ask me or my team at Holland Innovative. Best way to contact us is to send an email to lisette.van.steinvoren@holland-innovative.nl. Also if you are interested in a training with the basics for CE-marking for MDR we can help you.



    ------------------------------
    Johan Custers
    Eindhoven
    Netherlands
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    Original Message


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