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  • 1.  Flowchart B - Significant Change per MDCG 2020-3

    Posted 07-Apr-2020 14:07
    Dear RAPS team,

    I have a question w.r.t flowchart B in MDCG 2020-3.

    It says that any change in the change of built-in control mechanism, operating principles, source of energy or alarms are considered as a significant change. If we qualify a new power adaptor with the same power rating (100-200V) as the approved design, is it then a significant change?

    Appreciate your valuable feedback.

    Regards,

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    Soumya Rajesh
    Quality and Regulatory Affairs Manager
    Den Haag
    Netherlands
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  • 2.  RE: Flowchart B - Significant Change per MDCG 2020-3

    Posted 08-Apr-2020 05:10
    Hello Soumya,

    First you have to clearly define a "power adaptor" in context of the overall device, because this could be a line conditioner, the actual power source, or step-device for say a module recharging batteries.  When looking at a device, try not to look at just the component you are changing, but how this fits and contributes to the overall system.  Just because it has the same power rating does not necessarily mean the internal parts of that individual component do not affect the emissions or safety related to the overall device.  A first step would be completing a comparison of the old component to the new component such as side-by-side comparison of the specifications or operational functioning.  Then next step would be doing a risk assessment of the overall system how it applies to the complete finished device, if any changes are made.  A strong error often made is only looking at the individual component saying, 'has not changed,' but impacts to overall device is not reviewed.  So in answer to your specific question, I may not view this as a significant change, though not having information about your device would say it depends.  I could comment if this changes makes an assessment of the electrical safety or electromagnetic disturbance necessary including up to repeating any testing, it most likely would be considered a significant change.  (As a side-note, some Notified Bodies are viewing any change requiring update to EU MDR, so use caution switching out major/minor components in your device.)

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: Flowchart B - Significant Change per MDCG 2020-3

    Posted 08-Apr-2020 08:47
    Dear Richard,

    Thanks for your valuable feedback on my question! very much appreciated!
    Yes! This power adaptor is the actual power source (medical power supply) for our medical device.

    I have one more question.
    If we want to add an alternative power supply to our design which would help us to choose between the two based on availability (& we maintain the qualification reports within our DHF), does this change become a significant change or just change notification to NB would be sufficient?

    Thanks in advance!


    ------------------------------
    Soumya Rajesh
    Quality and Regulatory Affairs Manager
    Den Haag
    Netherlands
    ------------------------------

    Original Message


  • 4.  RE: Flowchart B - Significant Change per MDCG 2020-3

    Posted 09-Apr-2020 04:39
    Hello Soumya,

    If the power supply you are intended to make interchangeable from activities like back-up, supply source limitations, etc., as long as they are both qualified as a component should not be an issue.  Now from a significant change perspective, what I would recommend is reviewing your electrical safety reports to see if the power supply is identified as a "critical component."  If this is not clear inquire with your testing facility to ask them if the power supply is considered a critical component.  From a significant change perspective, if you are not replacing because of an issue, you are only sourcing a second power supply as "back-up" maybe you could write this internally as a non-significant change.  I personally would view it as a significant change if you were changing the power supply for another power supply because you had to such as failures encountered or the old power supply was no longer available.  Having an alternate power supply that is the same, maybe not a significant change ... you would have to make that decision.  If you are concerned about any regulatory implications, you could always communicate to the Notified Body what you are doing - meaning you are not sending a formal significant change notice - but more of a notification to let them know what you are doing.  Or again just make sure it is clear in your internal documentation what you are doing by sourcing another power supply as an alternate for logistical reasons.  The important thing to remember is the change is not being made because of an issue.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 5.  RE: Flowchart B - Significant Change per MDCG 2020-3

    Posted 09-Apr-2020 19:12

    The short answer is NO; your example is not a significant change.

    I infer that both the prior and new energy source is the AC mains. If so, you have not changed the source of energy. A change of source of energy would be, for example, a change from AC mains to battery power.

    The flowcharts have many characters in common with the FDA guidance document Deciding When to Submit a 510(k) for a Change to an Existing Device. The FDA guidance document is much better because it includes narrative information about the flowchart decision points.

    In particular the question in MDCG Flowchart B, B3 is essentially the question in FDA Flowchart B, B2. The FDA explanatory text says, "An example of an energy type input change is a change from AC to battery power; this type of change is usually part of a redesign to provide a portable device that can be used under different environmental conditions than the original device. Such a change would normally be accompanied by significant labeling changes, including a new or expanded indication for use. Note that this type of change does not include a change in voltage, such as from 3V to 9V operation or a change between different types of batteries, such as from NiCad to lead acid storage batteries".

    It would be nice if an EU-MDR Article 120(3) significant change aligned with an FDA 510(k) significant change. I doubt they are the same in all cases. However, in my opinion, the text from the FDA guidance documented is good guidance to use for the EU guidance document.



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


  • 6.  RE: Flowchart B - Significant Change per MDCG 2020-3

    Posted 10-Apr-2020 03:19
    From a product safety perspective and an EMC perspective, the change in a power supply would be a change in a critical component and a significant change for EN or IEC 60601-1 (Medical Electrical Safety standard) & EN or IEC 60601-1-2 MEE EMC standard).  Not specifically referring to the MDCG document.  Just from an IEC 60601 perspective, this is a significant change.  Will require retesting with the new power supply.  Any Notified Body that I have worked for will expect you to submit a significant change notification not based again on the MDCG as I have not reviewed this document yet so I can't comment on that yet.

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    Leonard (Leo) Eisner, P.E.
    The "IEC 60601 Guy"
    Principal Consultant, Eisner Safety Consultants
    Phone: (503) 244-6151
    Mobile: (503) 709-8328
    Email: Leo@EisnerSafety.com
    Website: www.EisnerSafety.com
    ------------------------------

    Original Message


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