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  • 1.  MDCG 2023-4 and classification

    Posted 06-Dec-2023 19:55
    Edited by Dragan Jovic 12-Dec-2023 06:39

    Hi community! I have a question here. If there is software for predicting fertility status based on certain parameters, according to MDCG 2019-11 that software should be classified as Class I. However, if the manufacturer also has a wearable sensor that merely collects and transmits data to the software for processing, how should that wearable be classified per MDCG 2023-4? If this wearable is indeed an accessory, it should be classified on its own right and considered an active device, i.e., Class IIa, which means that the entire system would be Class IIa. Does this mean that the software for predicting fertility, which was Class I according to MDCG 2019-11, can no longer be Class I due to the presence of the wearable sensor?

    Am I mistaken, and if so, where?



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    Dragan Jovic
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  • 2.  RE: MDCG 2023-4 and classification

    Posted 07-Dec-2023 01:37

    Hi Dragan

    You were right in the first place. Devices and accessories are each classified separately.

    It's normal to have class I devices and class II devices working together.

    If you had another piece of software that you were using to run the wearable hardware, that software would take on the hardware's classification, but that's not the case here. Since the behavior of the wearable is not influenced by the software that receives its data, this software remains in class I.



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    Anne LeBlanc
    United States
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    Original Message


  • 3.  RE: MDCG 2023-4 and classification

    Posted 07-Dec-2023 04:33

    Hello Dragan,

    I can second what Anne said, the software can remain as Class I in reference to the guidance documents you are citing.  Though keep in mind, internally your documentation, the intended purpose of each, and indications for use of each component/device needs to be clearly described and rationale/justification for approach documented.  It is common with Notified Bodies to lump everything into a system taking the default all devices and components work together dependently, absolutely.  If one or either as sold as an "accessory" or even just sold separately, they can be regulated separately, Technical Documentation separately, though used together, so it should be clear the relationship of the two devices.



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
    Oriel STAT A MATRIX - ENTERPRISE
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    Original Message


  • 4.  RE: MDCG 2023-4 and classification

    Posted 11-Dec-2023 16:10

    Dear Dragan

    I always take a look at the MDR prior to MDCG since the MDR is a regulation and MDCGs are not always aligned strictly with the regulatory text.

    Here there was a revision of the original released text (indicated by C1 - Corrigendum). 

    "Annex VIII Classification Rules. Chapter II Implementing Rules. Please consider 3.1 to 3.3 in this case. 

    3.1.  Application of the classification rules shall be governed by the intended purpose of the devices.

    3.2.  If the device in question is intended to be used in combination with another device, the classification rules shall apply separately to each of the devices. ►C1 Accessories for a medical device shall be classified in their own right ◄ separately from the device with which they are used.

    3.3.  Software, which drives a device or influences the use of a device, shall fall within the same class as the device."

    If the software is independent of any other device, it shall be classified in its own right.

    Best Regards,

    Stephanie



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    Stephanie Grassmann
    Founder & Managing Director of MedTechXperts Ltd
    Biberstein
    Switzerland
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    Original Message


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