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  • 1.  medical device software and MDR article 61

    This message was posted by a user wishing to remain anonymous
    Posted 29-Aug-2023 09:12
    This message was posted by a user wishing to remain anonymous

    Dear All,

    we have an App, which is classified as class III because of its interaction with class III components of the system (including implantable device). The app is a new product (does not have a predecessor, but some functionalities are shared with some with the other components from the system). The use of the App does not allow the user to perform any taks, which would lead to new clinical outcome as compared to when the clinician is involved, it only collects data on the other devices from the system and can transmit these data to the clinician. The App has an independent intended purpose but does not have independent clinical benefit outside of the whole system. So, I wonder how the MDCG2020-1 could be applied? And the second question is - do we really have to apply article 61, and if yes - which clause - 61 (10) does not apply to class III devices, and 61 (4) applies to equivalent devices.

    Thanks for your comments.

  • 2.  RE: medical device software and MDR article 61

    Posted 30-Aug-2023 03:05

    There are a lot of assumptions in this question that I cannot check, such as the classification of class III based on 'interaction' (interaction as such does not automatically lead to inheriting a risk class from another device). Are you sure that the app is a device in the first place? If it only moves data from other devices to the clinician it would not necessarily be a medical device under the MDCG 2019-11 flowchart, so I think we are missing some information. If the app does not have its own clinical benefit it may well be an accessory if it would be in scope of the MDR in the first place.

    If the device is in scope of the MDR, you will always go through article 61 because clinical evaluation is mandatory for a medical device, likely 61 (4) for a class III device. I don't understand the equivalent devices statement in this context.

    Erik Vollebregt

  • 3.  RE: medical device software and MDR article 61

    Posted 30-Aug-2023 04:21

    Good day Anon,

    While you have described what the software application (App) as a stand alone part of the overall system - there can be quite some interpretation around what all the components in the system does.  As Erik stated, there probably needs to be further information understand in the Class III device, what data is presented on the App, what the App actually "does", and why the software application would have its own intended purpose.  If the App does not perform any clinical decision making, then it might make more sense to have as an "accessory" which is only a part of the overall system.  Therefore, when doing clinical evaluation it is on the system, because doing clinical evaluation on an accessory or a stand alone App with no clinical decision process might be quite challenging.  As example, doing a clinical study for an App only because it might be connected to a Class III device and classified then as Class III - might be difficult to find physicians or healthcare professionals doing a clinical investigation on just an App.  You might want to seek some further advice on this App to understand best approach for regulatory positioning within the regulation classification and route to conformity.

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