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  • 1.  EUDAMED - Uploading Devices vs Components vs Accessories?

    This message was posted by a user wishing to remain anonymous
    Posted 06-Jun-2022 09:45
    This message was posted by a user wishing to remain anonymous

    Hi all,

    I am struggling to find information on what exactly counts as a 'device' to upload to EUDAMED.

    We have one BUDI-DI for our two models of medical device. Each model has a UDI-DI. Both models are listed by part number on our EC Cert (currently MDD but in process to go to MDR). Both models are listed in EUDAMED as a legacy device. I've also listed their Class I accessory (which is under MDR) in EUDAMED.

    Our device has other components and accessories that can be purchased as an extra, or used as a replacement. They do NOT appear on the EC cert. Do those components/accessories need to be individually listed in EUDAMED even though they are not independently medical devices? Or is it only the top level part/what is on our EC Cert that needs to be listed?

    Thanks in advance! You are all wonderful.


  • 2.  RE: EUDAMED - Uploading Devices vs Components vs Accessories?

    This message was posted by a user wishing to remain anonymous
    Posted 07-Jun-2022 09:09
    This message was posted by a user wishing to remain anonymous

    Hello,

    The general rule of thumb when it comes to devices on EUDAMED is that if it has UDI information, upload it. If the device/component/accessory does not have UDI assigned to it, then there is no need to list it on EUDAMED. 

    Check out Art. 23 on Parts and Components. Does the item significantly change the performance or safety characteristics or the intended purpose of the device when replaced with? If not, it is not a device, then no UDI requirement is applicable. If it does, it is classed as a device, which means UDI is required, and subsequently the information of that item needs to be uploaded onto EUDAMED. 

    It leads to Annex VI Part C 3.6 which states 'Each component that is considered to be a device and is commercially available on its own shall be assigned a separate UDI unless the components are part of a configurable device that is marked with its own UDI.'

    So, when you say your components can be purchased, namely commercially available on their own, but are NOT independently medical devices, I would say neither UDI assignment nor EUDAMED upload is required in your case.

    This is how I would interpret it. Would be great also to hear what others have to say.

    Kind regards
    Original Message


  • 3.  RE: EUDAMED - Uploading Devices vs Components vs Accessories?

    Posted 09-Jun-2022 00:04
    It is sometimes challenging to decide precisely what category a thing falls into.

    If they're not on the CE certificate, it might be because they aren't devices, or it might be they're class 1.

    Check each one against the definition of an accessory:

    'accessory for a medical device' means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s);

    If it's an accessory, the device rules apply. (And if it isn't, they don't.)

    If it's a spare part (a service part), then it's not a device, and not CE-marked under the MDR (though it could be CE-marked under some other applicable directive) and you don't register it as a device.

    For clarity, you may want to list all these things in the technical documentation, along with your rationales for what category each falls into.

    ------------------------------
    Anne LeBlanc
    United States
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    Original Message


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