In Vitro Diagnostic Regulation

The In Vitro Diagnostic Regulation (IVDR) replaced the IVDD and entered into force on 26 May 2017 with 26 May 2022 as date of application. In March 2023, the IVDR was amended as regards to transitional provisions for certain in vitro diagnostic (IVD) medical devices on Article 110(4) with the removal of the sell-off period to prevent unnecessary disposal of safe in vitro diagnostic medical devices that are still in the supply chain.


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.


IVDR conformity assessment routes

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