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.
Ann. I 20.4.1 (c)(v) for the official excerpt of the IVDR
Ann. I 20.4. , Ann. II 1. for the official excerpt of the IVDR
Click Adapted from Art. 17 for the official excerpt of the IVDR
Click Ann. I 1., 3., 8. 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