In Vitro Diagnostic Regulation (IVDR)

In Vitro Diagnostic Regulation (IVDR)

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IVDR In Vitro Diagnostic Regulation
IVDR In Vitro Diagnostic Regulation
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In Vitro Diagnostic Regulation

The In Vitro Diagnostic Regulation (IVDR) replaced the IVDD and entered into force on 26 May 2017. In January 2022 the IVDR was amended as regards to transitional provisions for certain in vitro diagnostic (IVD) medical devices and the deferred application of conditions for in-house devices.




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IVDR documentation submission

Download our IVDR Best Practices Guidelines to help you prepare and structure your Technical Documentation when planning your IVDR Conformity Assessment application to BSI.

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IVDR conformity routes

Our guiding brochure will support you in understanding conformity assessment routes and in selecting the most suitable for your in-vitro diagnostic device.