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  • 1.  Update to EU MDR Classification

    Posted 14-Feb-2022 14:25
    Good morning,
    Is anyone aware of where we can find information as to why the MDCG upgraded classifications for some devices?
    Our devices, oxygen concentrators, have been listed as IIa since the inception of the MDD and now (even though the rule in the MDR is basically worded the same as was in the MDD) the guidance document published in October 2021 (MDCG 2021-24) has them listed as an example for a IIb device without explanation as to why they are now "potentially hazardous" in regards to the nature of the substance involved, part of body concerned or mode of application.

    Our notified body is requesting a classification rationale and will not go against what the MDCG says.  They were only able to provide they thought it was the lack of oxygen from malfunction that was hazardous - but these devices are not life-supporting or life-sustaining, they provide supplemental oxygen.

    Any insight or direction would be most appreciated.

    Thank you,


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    Olivia Mullen
    Compliance / Regulatory Affairs
    Birmingham AL
    United States
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  • 2.  RE: Update to EU MDR Classification

    Posted 15-Feb-2022 05:24
    Olivia,

    Welcome to the mysterious world of the EU MDR.  I can not answer your question specifically as I have not experienced this instance, but we have with other devices seen a more "conservative" approach in differences between Class IIa and IIb for similar devices.  Devices which provide substances or does something to the body are being viewed with a higher risk level than in the past.  This also includes the application of accumulated use or continuous use of different devices.  One comment is reading Annex VIII at the beginning to understand if any of the "potentially hazardous" might be better explained.  The other recommendation is the one you have already started asking your Notified Body; just a comment there - maybe try to get the Notified Body to agree with your position from a risk management perspective.  Keep in mind the MDCG is a guidance document - it is still sad Notified Bodies are following these to letter of the law.  Make it clear to them it is a guidance document and your justification of providing supplemental oxygen is not potentially hazardous with all of the risks clearly defined in your risk management file.  But good luck with that, some of the ones we are working were products have been sold for 10+ years now are completely dangerous !  Seems like people leave their brains at home sometimes.

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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: Update to EU MDR Classification

    Posted 15-Feb-2022 08:12
    Hi Olivia

    As someone with asthma, sometimes severe, and having had relatives and friends with COPD and emphysema years ago, combined with seeing how COVID has played out, why would you think supplemental oxygen is not life- supporting or sustaining? 


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    Ginger Cantor, MBA, RAC
    Founder/Principal Consultant
    Centaur Consulting LLC
    River Falls, Wisconsin 54022 USA
    715-307-1850
    centaurconsultingllc@gmail.com
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    Original Message


  • 4.  RE: Update to EU MDR Classification

    Posted 15-Feb-2022 10:13
    Hi Ginger,
    I appreciate your question - our devices are intended to provide supplemental oxygen to treat hypoxemia (low levels of oxygen in the blood).  Hypoxemia is usually a condition of COPD, emphysema, or other respiratory or circulatory issues, and can cause headaches, confusion, shortness of breath.  Concentrators are usually prescribed as Long Term Oxygen Therapy as it's a safer and more economical alternative to tanks of oxygen.  Supplemental oxygen is not meant to cure or treat their disease, but it will keep patients comfortable and allow them to be more active then they would be without it.  Concentrators are not like ventilators that push air into the patients lungs, the patients should be conscious and able to spontaneously breathe on their own. 
    I hope that explains our position a little better.

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    Olivia Mullen
    Compliance / Regulatory Affairs
    Birmingham AL
    United States
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    Original Message


  • 5.  RE: Update to EU MDR Classification

    Posted 15-Feb-2022 09:24

    Presumably you mean EU-MDR Rule 12 and MDD Rule 11. In both cases the rule has two parts. The first is general and leads to Class IIa, while the second is specific and leads to Class IIb. The rule applies to "active devices intended to administer and/or remove …" and the specific part is "unless this is done in a manner that is potentially hazardous".

    For the MDD the corresponding document is MEDDEV 2. 4/1 Rev. 9. It does not have oxygen concentrators as an example. MDCG 2021-24 adds them as an example.

    The problem then is that the authors of MDCG 2021-24 apparently believe that an oxygen concentrator administers oxygen "in a manner that is potentially hazardous". Consequently, the device is in a higher risk class. You need to determine the specifics of the potentially hazardous manner. This means looking at your risk management file, any standards applied to meet the GS&PR, information from the Clinical Evaluation literature search, information from adverse event reports (use the FDA TPLC), etc.

    Then either convince the NB that it is not a potentially manner or accept the Class IIb.

    If it were me, I would accept the Class IIb because the difference in the EU-MDR between Class IIa and Class IIb is minimal and you would probably spend a lot of time making the argument with little chance of convincing the NB.



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


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