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  • 1.  IVD instrument label

    Posted 15-Dec-2014 20:21
    Hello RAPS members,

    According to ISO 18113-3 "The in vitro use of the instrument should be indicated when required by regulation". This can be accomplished by the word "For in vitro diagnostic use" or graphical symbol.

    Can someone please tell me where is this required as a regulation? We currently have an IVD instrument that is CE marked and placed on the market but does not contain a graphical IVD symbol on the label nor states the use of the product.

    Thank you.

    Ajay

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    Ajay Bhatia
    Salt Lake City UT
    United States
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  • 2.  RE: IVD instrument label

    Posted 16-Dec-2014 03:32
    Dear Ajay,

    For Europe it is stated in Annex I of the European IVD Directive 98/79/EC at point 8.4 (g) "The label must bear the following particulars which may take the form of symbols as appropriate: [...] where appropriate, a statement indicating the in vitro use of the device;"
    And at point 8.7 the same is ststed for the instructions for use. (Instructions for use are in Europe normally not understood to be part of  the term "labelling")

    It is relatively difficult to argue that it would not be apprioprate to do this for an instrument.

    Hope this helps,
    Jens

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    Jens Gerdelmann
    Senior Consultant
    MDSS GmbH
    Hannover
    Germany
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    Original Message


  • 3.  RE: IVD instrument label

    Posted 16-Dec-2014 11:06
    Canadian IVDD labelling regulations are in Sections 21-23 of the Medical Devices Regulations and they arefurther supported by guidance.  
    http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/labl_etiq_ivd_div-eng.php 

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    Brigitte Zirger
    Cranberry Creek Associates
    Canada
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    Original Message


  • 4.  RE: IVD instrument label

    Posted 16-Dec-2014 14:20
    Hello Ajay,

    In Vitro Diagnostic products have special labeling requirements under 21 CFR 809, Subpart B, "In Vitro Diagnostic Products for Human Use".

    You might want to review:

    1) "In Vitro Diagnostic Device Labeling Requirements".
    http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/DeviceLabeling/InVitroDiagnosticDeviceLabelingRequirements/default.htm

    and

    2) "Points to Consider Regarding Labeling and Premarket Submissions for Home Use In Vitro Diagnostic Devices".
    http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm094277.htm

    Nazanin Shalchian-Gregoretti, M.D., M.S.

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    Nazanin Shalchian Gregoretti MD
    Lexington MA
    United States
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    Original Message


  • 5.  RE: IVD instrument label

    Posted 16-Dec-2014 17:43
    Hi,

    There is a statement in the essential requirements checklist in section 8.4 of the directive.

    Hope this helps!

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    Sarah Phillips
    Universal Biosensors
    Melbourne
    Australia
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    Original Message