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  • 1.  EU classification-- duration

    Posted 08-Sep-2017 15:08
    Is the duration of use for device classification based on patient contact or overall intended use?  We have devices that are non-contact or make indirect patient contact.  Do I need to include that duration in my classification rationale summary?

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    Jackie Jaskula
    Sr. QA/QC Manager
    Austin TX
    United States
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  • 2.  RE: EU classification-- duration

    Posted 09-Sep-2017 04:20
    Dear Jackie,

    If your product is not in contact with the patient, the duration of use does not apply. Duration of use only applies to invasive devices. In your rationale you may state exactly that. The same rationale applies with both the Medical Device Directive and the new Medical Device Regulation.

    The product's intended use was not described in your message, so be sure to consider every aspect.

    PS. We can continue one-on-one if you have any doubts or you can check the digital aide we've built to help anybody with EU classification.

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    Heikki Pitkänen
    CEO & Founder
    Lean Entries Ltd
    Finland
    +358(44)2380006
    heikki.pitkanen@leanentries.com
    www.leanentries.com
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    Original Message


  • 3.  RE: EU classification-- duration

    Posted 10-Sep-2017 08:29

    Hi, you will find some guidance in MEDDEV 2.4/1 on classification, with some example towards duration. Key is how long the mode of action is effective.

    Best regards, Gert




    Original Message


  • 4.  RE: EU classification-- duration

    Posted 10-Sep-2017 08:38
    Base it on contact with the USERS, which are people who come into contact with the device in the course of its intended use. This can include not only patients, but physicians and other healthcare providers.  (Think latex gloves and sharps.)

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    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
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    Original Message


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