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  • 1.  Regulatory Authority Challenges Classification.

    This message was posted by a user wishing to remain anonymous
    Posted 10-Jan-2020 08:59
    This message was posted by a user wishing to remain anonymous

    We have a Class I medical device available worldwide. 
    In an external audit (for class I) the classification of the medical device was challenged and the audit was canceled.
    No formal report/ audit NC were created. 
    After several correspondences with that health authority, it has been decided to up classify the device ( from I to II)
    Is that something we should report to other health authorities in the world ? 


    Thank you!


  • 2.  RE: Regulatory Authority Challenges Classification.

    Posted 10-Jan-2020 09:48

    No do not report it. Classification is an attribute of the regulatory system, not the device. A device could be in different classes in different regulatory systems.

    I don't know of a requirement to report the regulatory class in one system to the regulators in another.

    Reporting could open up the possibility of many clarifying questions



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


  • 3.  RE: Regulatory Authority Challenges Classification.

    Posted 10-Jan-2020 10:34

    In most (if not all) regulatory jurisdictions, the classification scheme is based on the device attributes, not on attributes of the regulatory system, nor other attributes.  Specifically, the classification scheme is most typically based on device risk.

     

    For a device that is available worldwide, it is important to apply the device classification rules for each regulatory jurisdiction in their own right so as to know how each jurisdiction classifies the device.

     

    Once the proper device classification is determined for each jurisdiction, then it is required to fulfill the corresponding regulatory obligations.  In most (if not all) cases for a device falling into a moderate risk category (e.g., class II, class 2, class IIa, etc.), "reporting" (in the form of premarket notifications, license applications, conformity assessment applications, significant change notifications, etc.) is absolutely a requirement.

     

    Accordingly, not reporting such a change or classification will most certainly lead to serious adverse legal and/or regulatory compliance consequences.

    ------------------------------
    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    ComplianceAcuity, Inc.
    Golden, CO
    United States
    www.complianceacuity.com
    © Copyright 2020 by ComplianceAcuity, Inc. All rights reserved.
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    Original Message


  • 4.  RE: Regulatory Authority Challenges Classification.

    Posted 10-Jan-2020 10:26
    You don't need to report to other authorities. It is important that "classification" is NOT a non-conformance, safety notice or any other type of reportable regulatory action. It varies in each geography, as they have unique rules (for instance, I once had a product that was Class 1 in US and Class IV in Canada).

    Depending on the rationale for the up-classification, it is probably worth an internal assessment to see if a similar rationale would cause the product to be re-classified in other geographies. If you deem that it would, it might be worth having a discussion with that authority specifically.

    g-


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    Ginger Glaser RAC
    Chief Technology Officer
    MN
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    Original Message


  • 5.  RE: Regulatory Authority Challenges Classification.

    Posted 14-Jan-2020 17:05
    Are they allowing you to continue to market the device in the interim?

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

    Original Message


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