Progressive roll-out of the In Vitro Diagnostic Medical Devices Regulation

The In Vitro Diagnostics Regulations (2017/746) still come into effect from 26th May 2022 after being rescheduled from 26th May 2021 due to COVID-19. However, due to a shortage of notified body capacity, the European Commission have acknowledged that there is a risk of disruption in the supply of in vitro diagnostic devices.

For this reason, the European commission have decided that to roll out the transition period based on the risk classification of the device with higher risk devices, such as HIV or hepatitis tests (class D), the new requirements will apply from May 2025. For devices of the lower risk class C, such as certain influenza tests, the date of the application is extended until May 2026, whilst for lower risk class devices (class B and A sterile), the application starts in May 2027. Furthermore, devices that were on the market prior to 26th May 2022 and did not require a notified body, for which a declaration of conformity was drawn up prior to 26th May, may be placed on the market in accordance with the dates outline above.

The changes do not impact devices that do not require notified body certification under the IVDR. Importantly, there is no extension provided for IVDs that are ‘new’ to the market and have not been certified or declared for conformity under the IVDD. For these devices, and devices that have undergone a significant change in design or intended purpose, the IVDR will apply in full from 26th May 2022, as planned.

You can find out more information about the progressive roll-out of the IVDR here.