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  • 1.  Significant changes under MDD

    This message was posted by a user wishing to remain anonymous
    Posted 06-Jul-2021 09:18
    This message was posted by a user wishing to remain anonymous

    Hi Team,

    I have a question- there is a plan to change the supplier of a critical component and replace the component in installed base with the new supplier as and when required. The installed base product in CE marked under MDD. The technical file is under review for MDR.

    Any idea how this change can be handled? Should we wait to implement this change till we get CE certificate under MDR and then inform NB about this change?

    Thanks for the help.


  • 2.  RE: Significant changes under MDD

    Posted 06-Jul-2021 16:10
    Edited by Kevin Randall 06-Jul-2021 16:13
    Tricky question.  I'll break the ice:

    If changing the supplier of a critical component that will be, or could be, subsequently used for component replacement in devices already installed (i.e., already put into service) in the Union prior to 26 May 2021 under an MDD Declaration of Conformity (DoC) and Notified Body (NB) certificate, then the most ideal regulatory scenario is to be able to conclude that such a change is not a "significant change".  If that argument can be sustained, then it eliminates much of the grappling required by the EU MDR.  I explain further below where I lay out a basic framework of the regulatory strategy path I would follow:

     

    1. First remember that NB notification about device changes is subject to the particulars of the agreed arrangement (i.e., the contract) in place with the NB. Traditional precedent under the MDD being maintained under the EU MDR is that, in case of doubt whether a change is significant, the regulatory strategy should be formulated in consultation with the NB.

     

    1. Thoroughly explore whether the change in critical component supplier can be justified as not significant.  NBOG precedent (see NBOG 2014-3) and modern reiteration by the MDCG (see MDCG 2020-3) for the EU MDR leave open the possibility that critical supplier and component changes could possibly be justified as being not significant.  I would also add that changes involving devices on the lower end of the risk-class spectrum may have relatively greater liberty to be categorized as not significant.   If the "not significant" argument can be sustained, then it's profound because such a change and the already-installed devices wouldn't exceed the "significant change" threshold of EU MDR Article 120(3), consequently allowing continued service under the authority of the MDD DoC and certificate.  A cornerstone of this rationale is threefold:  a) the devices were already put into service; b) "putting into service" seems by fundamental definition to be just a once-in-a-lifetime event for each device unit; and c) the EU MDR DoC and certification requirements only apply to devices placed on the market, made available on the market, or put into service from 26 May 2021 [notwithstanding the provision of Article 120(5) of course].  Indeed, my interpretation is that, as a general rule, devices put into service under the MDD will never become subject to the EU MDR [except for the conditions in the final sentence of Article 120(3), and except for any ultimate cutoff date (I know of none) for allowing such devices to remain in service] unless a significant change is made (effectively resulting in a "new" device and the need for its own respective conformity assessment and once-in-its-lifetime putting into service).

     

    1. On the other hand, if the change in critical component supplier and subsequent replacement of components in previously installed units is definitively found to be significant, then by default, that would seem to effectively result in a "new" device, thus nullifying the eligibility for the EU MDR Article 120(2) and (3) transitional provisions. This means that such a change would not be allowed from 26 May 2021 without a corresponding valid EU MDR DoC and NB certificate for the changed version and unit.  But the NB's interpretation of this needs to be determined, particularly regarding the aforesaid "new" device notion, as different NBs could have varying interpretations of how they would approach this.


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    Kevin Randall, ASQ CQA, RAC (Europe, Canada, U.S.)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
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  • 3.  RE: Significant changes under MDD

    Posted 06-Jul-2021 16:17
    Made some important clerical edits a few minutes after posting; please be sure to read the latest...

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    Kevin Randall, ASQ CQA, RAC (Europe, Canada, U.S.)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
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  • 4.  RE: Significant changes under MDD

    Posted 07-Jul-2021 04:37
    In my opinion, if you are referring only to MDD CE marked devices that are already 'in service' with end users, the only part of the MDR that will apply is the requirement in the transitional provisions Article 120(3) that requires legacy devices to adhere to the "post-market surveillance, market surveillance, vigilance" requirements of the MDR.

    So you will need to document whether the field action taken to replace these components meets/doesn't meet the criteria for reporting under the vigilance requirements in MDR Article 87 or the 'corrective action' reporting requirement in Article 83(4).

    Of course, new MDD CE marked devices being placed on the market after the component has been replaced must be assessed to ensure that the change is not 'significant' according to MDR Article 120(3), and if it is, then MDR-compliance must be confirmed before these revised devices can be placed on the EU market.

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    Roger Gray
    VP Quality and Regulatory
    Donawa Lifescience Ltd
    UK Responsible Person services
    Christchurch, UK
    +44 1425 489208
    rgray@donawa.com
    www.donawa.com
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  • 5.  RE: Significant changes under MDD

    Posted 07-Jul-2021 08:48
    Is your submission under administrative or technical review right now? If it's under technical review and you have a limit to rounds of queries I would contact your NB and involve them as Kevin suggests.

    If you are replacing components even in the field I would be careful trying to argue this is not a significant change. Was the new supplier the result of CAPA?

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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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  • 6.  RE: Significant changes under MDD

    Posted 07-Jul-2021 12:16
    Edited by Kevin Randall 07-Jul-2021 12:21
    Remember (see my post from yesterday) that EU MDR requirements (like EU MDR vigilance procedures, EU MDR corrective action reporting, etc.) generally doesn't apply for changes involving device units that were legally placed on the market and put into service in the Union prior to 26 May 2021 unless a significant change is made that renders the devices to be "new" devices.  In other words for example, if the change to such pre-26 May 2021 devices are part of a FSCA, then the FSCA requirements of the MDD apply, not the EU MDR.

    Particular EU MDR requirements will only become applicable regarding devices placed on the market, made available on the market, or put into service in the Union from 26 May 2021 [notwithstanding the provision of Article 120(5) of course] or regarding significant changes to pre-26 May 2021 units.

    Therefore, be careful not to unnecessarily/improperly apply EU MDR requirements to devices legally placed on the market or put into service before 26 May 2021 [except regarding Article 120(5)].


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



  • 7.  RE: Significant changes under MDD

    Posted 07-Jul-2021 13:30
    Edited by Ed Panek 07-Jul-2021 13:47
    If a new risk is identified and a CAPA implemented to correct it I thought it was considered a significant change under MDR and chart B of MDCG 2020-3. For example, a new risk is discovered and corrected via CAPA. What is required?

    For example, there is a risk a power supply temperature has a risk of contact burns with a user. An insulating layer is placed around the PS and ventilation is added. Field complaints indicate some users suffering discomfort when accidentally touching the power supply. Additional insulation and venting and relocation of power supply are added to correct. Is that a new risk? 

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



  • 8.  RE: Significant changes under MDD

    Posted 07-Jul-2021 14:33
    Ed, great comments and questions as always!  I've thus far in this thread intentionally not explored what is or isn't a significant change, as that seems worthy of an entire discussion in its own right.  For detailed discussions on distinguishing between significant change and not significant change, I wonder if we should start a new discussion for that topic?  Or maybe Anon can let us know if that would be germane to the initial question?  Any thoughts Anon?

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



  • 9.  RE: Significant changes under MDD

    Posted 07-Jul-2021 23:22
    In my opinion, you should be separation case by case such as MDD and MDR.

    In case of MDD, if you have any changed in certified product. You should be checking for MDCG 2020-3 (Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD). And you can follow it.
    And then, if your product could be determined as significant change. You do not changed in MDD certified product. And you must apply for MDR.
    If your product could not be significant change. You can ask to your MDD NB to update it.
    So, you can ask to your MDD NB about it.

    In case of MDR, you can freely change any part and any intended use etc...
    I think, you don't need to consideration for MDD during conformity assessment by MDR.

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    ALEX YOU
    Seoul
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