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Switching Notified Bodies - Does MDD Certificate Stay Valid?

  • 1.  Switching Notified Bodies - Does MDD Certificate Stay Valid?

    This message was posted by a user wishing to remain anonymous
    Posted 27-Nov-2023 09:07
    This message was posted by a user wishing to remain anonymous

    Hi Everyone,

    As always, I appreciate everyone's knowledge and contribution to the forum.

    My question is as follows:

    We are currently contracted with a NB (let's call it NB #1). We have a Class IIa device with MDD Certificate, issued by NB #1.

    If we were to enter contract with NB #2, does the MDD Certificate issued by NB #1 stay valid?

    Thank you for your time.



  • 2.  RE: Switching Notified Bodies - Does MDD Certificate Stay Valid?

    Posted 28-Nov-2023 04:06

    It does not stay valid. Changing notified bodies requires the new notified body to issue a new certificate in its own name. This is logical because the notified body that originally issued the certificate affords the manufacturer the right to affix its notified number to the device and label, so this needs to match the notified body that exercises surveillance over the manufacturer.

    There are some very limited exceptions to this rule in a legacy device scenario where surveillance is transferred (article 120 (3e) MDR).



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    Erik Vollebregt
    Partner
    Amsterdam
    Netherlands
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  • 3.  RE: Switching Notified Bodies - Does MDD Certificate Stay Valid?

    Posted 29-Nov-2023 14:26

    I agree



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    Armin Beck
    CEO
    SunTrixConsulting LLC
    El Dorado Hills, CA
    1-925-212-7683
    armin.beck@suntrixmedical.com
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  • 4.  RE: Switching Notified Bodies - Does MDD Certificate Stay Valid?

    This message was posted by a user wishing to remain anonymous
    Posted 10 days ago
    This message was posted by a user wishing to remain anonymous

    In the scenario of MDR art. 120 3e: the NB#2 takes over the MDD device surveillance (until year 2027/2028) of related MDD devices (part of associated MDR contract) shall the manufacturer assign the NB#2 number on related device labels and get also (MDD?) certificate from NB#2? This is even more important if the NB#1 is not anymore MDR-designated/ listed! What are your thoughts and experience about this particular situation?




  • 5.  RE: Switching Notified Bodies - Does MDD Certificate Stay Valid?

    Posted 10 days ago

    Hi Anon,

    it might be better to open a new thread instead of reviving this one in the middle of things.

    That said: The respective Q&A document by the EU states that both solutions can work (although as with all guidance documents it remains one possible interpretation and is not necessarily binding). I currently know no respective case.

    Best regards, Christoph



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    Christoph Kiesselbach
    Schrack & Partner
    Reutlingen
    Germany
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  • 6.  RE: Switching Notified Bodies - Does MDD Certificate Stay Valid?

    Posted 8 days ago

    Aligned wih Christoph. 

    1. Labelling could stay with the NB nb 1. Here is the extract of the Q&A, question 16  

    16. In case there is an arrangement for the transfer of the surveillance to a different notified body designated under MDR, what are the implication on the labelling concerning the notified body's identification number?

    Even when the appropriate surveillance is transferred to a different notified body designated under the MDR, legacy devices can continue to be placed on the market and made available without changes to the labelling, including CE marking, and thus indicate the number of the notified body that issued the certificate under the Directive and that is kept valid.

    However, if practically feasible and depending on details included in the tripartite agreement (see question no 13 of this document) the manufacturer may decide to modify the labelling of legacy devices indicating the number of the notified body to which a formal application under the MDR has been lodged. 

    2. To the best of my knowledge, the current MDD certificate would still valid +

                        A. tripartite contract manufacturer -NB1 - NB2 transferring the surveillance activities to NB1

                       B. confirmation letter from the NB2 on the MDR products roadmap

                       C. the self declaration - make it clear in both documents that you are switching NB.

    This is also supported by the MDCG guidance 2020-3 indicating the during the transitional period, notified bodies cannot issue new MDD certificate. 

    Beatrice NAJEM

    CEO & founder 

    QuaRex Consulting LLC 



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    Beatrice NAJEM
    CEO & Founder of quarex consulting LLC
    Belmont MA
    United States
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  • 7.  RE: Switching Notified Bodies - Does MDD Certificate Stay Valid?

    Posted 8 days ago

    Good information Beatrice.  Are you saying that the NB number can remain on the label even if the MDD NB no longer exists or is otherwise no longer available to be responsible for the MDD certificate? Thanks for your insights.



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    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright by ComplianceAcuity, Inc. All rights reserved.
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  • 8.  RE: Switching Notified Bodies - Does MDD Certificate Stay Valid?

    Posted 8 days ago

    Good day Keven,

    Yes, according to the Q&A keeping the NB nb is a possibility and changing it if it is feasible and agreed within the 3 parties. 

    I totally recommand the manufacturer to raise this question with the new NB. 

    Béatrice 



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    Beatrice NAJEM
    CEO & Founder of quarex consulting LLC
    Belmont MA
    United States
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  • 9.  RE: Switching Notified Bodies - Does MDD Certificate Stay Valid?

    Posted 10 days ago
    Edited by Kevin Randall 10 days ago

    The Union MDR is not specific about the labeled NB numbering aspect during the Article 120(3e) transfer of surveillance except for the MDD's and MDR's enduring basic purpose for the NB number.  Thus, I bear in mind that ultimately, the NB number's legislative purpose [see Union MDR Article 20(5) / MDD Article 17] has not changed; namely that purpose is to identify the NB responsible for the conformity assessment procedures set out in Article 52.  In practical terms, this means the NB who issued and controls the EC certificate.  For example, if the MDD NB continues to be responsible for the MDD certificate (even though the MDD NB may have delegated surveillance activities to the MDR NB) and the MDD certificate remains valid (hasn't been withdrawn or made otherwise invalid such as by way of the NB's termination of business), then it seems most legislatively proper to keep the MDD certificate NB's number on the label.  Failure to do so runs the risk of nonconformity with the basic intent of MDD Article 17 / MDR Article 20(5) and of NBs in general.  I would generally only switch to the MDR NB's number once it becomes responsible for the device's conformity and certificate (not just for surveillance).  For example, in relation to Article 120(3e)'s "where practicable" feature [and the similar feature inherent in Article 120(3)'s MDD legacy device provision requiring a valid MDD certificate which includes assuring that the MDD NB itself remains valid (see MDCG 2019-10)], I would not use the MDD certificate NB's number if that NB is out of business.  Yet if the MDD NB remains available for oversight of the legacy MDD certificate even though it may not be designated under the MDR, then I think such a scenario is where the Q&A document's flexible approach would be most appropriate.



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



  • 10.  RE: Switching Notified Bodies - Does MDD Certificate Stay Valid?

    Posted 10 days ago

    agreed



    ------------------------------
    Armin Beck
    CEO
    SunTrixConsulting LLC
    El Dorado Hills, CA
    1-925-212-7683
    armin.beck@suntrixmedical.com
    ------------------------------



  • 11.  RE: Switching Notified Bodies - Does MDD Certificate Stay Valid?

    Posted 28-Nov-2023 04:41

    Hello Anon,

    This depends on how your contract is currently with NB #1, status, and CE Certificate.  Under the Implementing Regulation a contract needs to be in place with a NB for current EU MDD CE Marked devices in order to extend the life of the device's certificate.  I am not sure your situation if even you secured a contract with NB #2, this would not extend the EU MDD CE Certificate from NB #1.  



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
    Oriel STAT A MATRIX - ENTERPRISE
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  • 12.  RE: Switching Notified Bodies - Does MDD Certificate Stay Valid?

    Posted 29-Nov-2023 14:11

    Hello Anon,

    Be aware that on the date of entry into force of the MDR, EU NB's could no longer issue a new MDD certificate. There was talk about us changing NB for an MDD extension but it was not possible for this reason. Speak with your proposed/desired new NB to be clear on what can/cannot be done - plus it will help to build the professional relationship.



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    Dave Ratcliff
    Quality & Regulatory Affairs Manager
    Hereford
    United Kingdom
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  • 13.  RE: Switching Notified Bodies - Does MDD Certificate Stay Valid?

    Posted 8 days ago
    Edited by Ronald Boumans 8 days ago

    This is where Article 120(3e), second paragraph, is about. The certificate remain valid, but this manufacturer must have an agreement with NB#2 to take over surveillance of the devices covered by the certificate issued by NB#1. The reason behind this is, that it should be possible to switch notified body during this transition period. This is a must in the case the outgoing notified body is not designated under the MDR. 

    The interesting thing would be to see what happens in the case NB#2 finds serious non-compliances during their surveillance audit. My recommendation to all manufacturers that switch notified body now, is to ensure the technical documentation is fully MDR ready to enable a quick switch. Note that it is now February and this issue may start playing up after September of this year. No time to waste, I would say...



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    Ronald Boumans
    MDR Expert
    Super PRRC
    Netherlands
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