IVDCheckR
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    • Information
    • LDT project description
    • Method comparison
    • Quality control
    • Chemicals and software
    • Disclaimer


    Welcome to IVDCheckR, your comprehensive integration platform designed to ensure IVDR compliance for your laboratory developed tests (LDTs) according to Article 5 (5) of the in Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (EU-IVDR). Begin by pressing the start button below, you'll be directed to the LDT project details landing page, where you can enter specific details of your project.


    Click here for the official website of the EU-IVDR.



    How to use this tool:


    1. Press the 'Start' button.

    2. Add specific details about your project in the project details tab.

    3. Perform method comparison using the Method Comparison tab (optional).

    4. Perform quality controls using the Quality Control tab (optional).

    5. Download a combined PDF to get a complete report.


    Download Combined PDF

    -
    Click Ann. I 20.4.1(c)(i) , Ann. II 1.1 (c)(i) for the official excerpt of the IVDR

    Click Ann. I 20.4.1(c)(i) , Ann. II 1.1 (c)(i) for the official excerpt of the IVDR

    Click Ann. I 20.4.1(c)(iii) , Ann. II 1.1 (c)(iii) for the official excerpt of the IVDR

    Click Ann. XIII A 1.2.1 for the official excerpt of the IVDR


    Ann. I 20.4.1 (c)(v) for the official excerpt of the IVDR


    Ann. I 20.4.1 (c)(vi) , Ann. II 1.1 (c)(vi)/6.1.1 for the official excerpt of the IVDR

    Click here for detailed risk classification
    Click Ann. VIII for the official excerpt of the IVDR

    Click here for IVDR criteria for SOPs
    Ann. I 20.4. , Ann. II 1. for the official excerpt of the IVDR
    Click Art. 5 (5)(d) for the official excerpt of the IVDR
    Click Adapted from Art. 17 for declaration of conformity template
    Click Adapted from Art. 17 for the official excerpt of the IVDR
    Click here for risk management life cycle
    Click Ann. I 1., 3., 8. for the official excerpt of the IVDR

    Click Art. 5 (5)(i) for the official excerpt of the IVDR

    Click Article 2 (39-46) , Annex I.9 , Annex XIII A 1.2.2 and 1.2.3 for the official excerpt of the IVDR

    Click Article 2 (39-46) , Annex I.9 , Annex XIII A 1.2.2 and 1.2.3 for the official excerpt of the IVDR


    MC Tool

    Enter details of method x and y

    Reference range (from/to)
    Reference range (from/to)
    Enter or copy/paste raw values for method x and y

    Plots



    QC Tool

    Analyte

    Description

    QC type

    Target values

    Results

    List of used chemicals and software