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  • 1.  EU MDR Classification Rules

    This message was posted by a user wishing to remain anonymous
    Posted 11-Dec-2019 16:34
    This message was posted by a user wishing to remain anonymous

    ​We currently have CE mark on our Ultrasound Gel product family as a Class I and Is in the EU. In transitioning to EU MDR and with the addition of rule 21, it has been implied that these types of devices may be upclassed to IIa.

    "Devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and absorbed by or locally dispersed in the human body are classified as... Class IIa if they are applied to the skin… and achieve their intended purpose on those cavities"

    Based on the definitions of a substance from MDD 2001/83/EC and Article 1 (8) of EU MDR, are Notified Bodies upclassing these previous Class I devices? Or can rationale be enough to support why we believe they will remain Class I?


    Thank you for your input!



  • 2.  RE: EU MDR Classification Rules

    Posted 12-Dec-2019 02:40
    Edited by Spyros Drivelos 12-Dec-2019 03:19
    Hi Anon,

    Although Rule 21 is specific, it is also very general. In my opinion you can talk with the NB (if you have) or a competent authority, in order to classify the device based on the actual risk of the product.
    MDR opens a new area and trust me that, not even the NBs or the CAs know what they will face in the future.
    In my opinion the first cases will lead the way to the next ones.

    Hope that helps

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    Spyros Drivelos
    Medical Devices Expert
    Agia Paraskevi, Athens
    Greece
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    Original Message


  • 3.  RE: EU MDR Classification Rules

    Posted 12-Dec-2019 03:41
    Dear anonymous,

    I presume the ​Ultrasound Gel product family is an accessory to active Ultrasound devices and therefor to be treated as medical devices in their own. I also presume the gels are intended to be used on intact skin of patients and not invasive.
    You are indeed right that Rule 21 of the MDR is then applicable and I agree that indent three is applicable, leading to the conclusion that this Gel is to be up classified to IIa under MDR.
    This is your decision as a legal manufacturer, the Notified Body is not going to do that for you. For your class Is devices a Notified Body is already involved, so it might be possible that one way or another they will start discussing the up classification, but I would not count on it.
    I cannot see how you can reason in a rationale that the classification of these devices remain I and Is under the MDR, but that's your prerogative.

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    Peter Reijntjes
    Principal Consultant Regulatory & Quality Affairs
    Arnhem
    Netherlands
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    Original Message


  • 4.  RE: EU MDR Classification Rules

    Posted 12-Dec-2019 06:06
    Greetings Anon!
    Probably, if you think you should be a class IIa, you will be ... but as always the devil is in the detail:
    1. it will depend on the words you put around your product: intended use, indications, contraindications, claims etc (not all gels will be the same) then argue these against the classification rules
    2. you can ask an NB to confirm your decision and many will do this
    3. you can often ask your CA, but this may cost and, once you ask a CA, you can not un-ask the question if you do not like the answer. You might find yourself stuck because of a poor choice of word, and not really understanding how your product was used, with something that will come back to haunt you!
    4. if you think you are up-classified then the provisions of MDR corrigendum 2 may give you extra transition time after
    Lastly, don't forget many of the other new requirements of the MDR will impact you, e.g. even if you use the transition arrangements for your certificate, the new economic operators, quality system, surveillance, vigilance, UDI/EUDAMED requirements all apply.
    If you are not EU based, keep your EUAR up to speed as their role is much bigger under the MDR.

    There is loads more I could say, but I hope this gives you a start.

    Neil

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    Neil Armstrong FRAPS
    CEO MeddiQuest Limited
    Peterborough
    United Kingdom
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    Original Message


  • 5.  RE: EU MDR Classification Rules

    Posted 12-Dec-2019 09:56
    ​The gel is applied to the skin, but does it supposed to be absorbed or locally dispersed in the human body? If the answer is No, just based on the rule 21 you cited, one could argue it should remain as Class I.

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    Hugo Xi
    Abbott Park IL
    United States
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    Original Message


  • 6.  RE: EU MDR Classification Rules

    Posted 12-Dec-2019 10:01
    Hi,

    I agree with the above. If you already believe it might be upclassified but you are not entirely sure, start the discussion with your NB before doing the work needed for a class IIa.

    When looking at the classification rule in this particular case, I would argue it remains class I but I cannot say for sure without more details. Reason I would not yet conclude it becomes IIa is of the word 'intended': Are there substances in the gel that are intended to be absorbed/locally dispersed in the body? If not, in my opinion the rule does not apply to this device.

    Br,

    Niels

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    Niels Festjens
    Sint-Katelijne-Waver
    Belgium
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    Original Message


  • 7.  RE: EU MDR Classification Rules

    Posted 13-Dec-2019 13:09
    I agree with this. I would first try to resolve internally, but ensure a robust analysis and justification.

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    Corey Jaseph RAC
    Director of Regulatory Affairs
    South Jordan UT
    United States
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    Original Message


  • 8.  RE: EU MDR Classification Rules

    Posted 12-Dec-2019 17:39

    Before you can determine the rule to apply, you need to clarify some issues.

    Clarify the intended purpose and how the device achieves its intended purpose.

    Because you cite Article 1(8), you imply that the device has a medicinal product. You need to be clear whether it does.

    You mention that the product has two variants, sterile and non-sterile. Do both variants have the same intended purpose and achieve it in the same way? Also, you should note that neither MDD nor MDR has a Class Is. There are only four classes: I, IIa, IIb, and III.

    Note that the MDR does not include a definition of substance or medicinal substance because they are in other directives that the MDR references (I don't think we need the definitions here)

    Without understanding the details of either variant, I state:
    -- The intended purpose is to facilitate the transmission of acoustic signals from the transducer to the anatomic area under consideration and return
    -- It achieves its intended purpose by "reducing the impedance" between the transducer and the patient's skin (I have a background in electronics, but ultrasound may use different words)
    -- Neither variant includes a medicinal substance
    Now, to the analysis of Rule 21

    Parse the main part:
    a) The device is composed of substances or of combinations of substances – Yes
    b) The substances are intended to be introduced into the human body via a body orifice – No
    c) The substances are intended to be applied to the skin and absorbed by or locally dispersed in the human body – No

    Rule 21 applies in only two cases using my notation above:
    The device satisfies both a) and b)
    The device satisfies both a) and c)

    Your device does not, in my opinion, satisfy either case. Rule 21 does not apply.

    In my experience, after getting an ultrasound the technician hands me some towels to wipe the goop off my skin. She never says, "Oh just wait a bit and it will be absorbed".



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


  • 9.  RE: EU MDR Classification Rules

    This message was posted by a user wishing to remain anonymous
    Posted 13-Dec-2019 12:09
    This message was posted by a user wishing to remain anonymous

    So to clarify​ the original post, the non-sterile formulation is non-invasive intended for intact skin only. The Sterile formulation is considered invasive in regards to medical ultrasound procedures on or near mucosal membranes through body orifices (transient use).

    Based on this, we do not feel that the intent of the ultrasound is not to be absorbed or dispersed in order to achieve its intended purpose.
    Original Message


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