BSI Transitions

In Vitro Diagnostics (IVDR)

In Vitro Diagnostics (IVDR)

The regulation gives manufacturers five years to transition to the new IVD Regulation. The new rules will apply from May 2022 for IVD devices.

The regulation gives manufacturers five years to transition to the new IVD Regulation. The new rules will apply from May 2022 for IVD devices.

Red Overlay
ivdr banner
ivdr banner
Red Overlay

In Vitro Diagnostic Regulation IVDR

The In-Vitro Diagnostic (IVD) industry is undergoing significant change. The IVD Regulation (2017/746), which replaces the IVD Directive (98/79/EC), entered into force on 25 May 2017. This started the transition period of five years for manufacturers selling IVD devices into Europe.

Manufacturers have the duration of the transition period to update their technical documentation and processes to meet the new requirements. BSI is committed to ensuring a smooth transition for all clients wishing to certify to the IVDR.