Some extremely welcome news for the entire industry, clinicians and patients.

Press release14 October 2021Brussels

‘Public health: Commission proposes a progressive roll-out of the new In Vitro Diagnostic Medical Devices Regulation’

……The IVD Regulation was planned to apply as from 26 May 2022. However, there is a serious shortage of notified body capacity, making it impossible for manufacturers to conduct the legally required conformity assessment procedures in time. Without any legislative action, there is a risk of significant disruption in the supply of various essential in vitro diagnostic medical devices on the market, affecting the diagnosis of patients and their access to relevant health care. Hence today's proposal to ensure a progressive roll-out of the IVDR.

The proposal does not change any requirements of the In Vitro Diagnostic (IVD) Regulation in substance but only changes the transitional provisions to allow the Regulation's progressive rollout. The length of the proposed transition periods depends on the type of device: higher risk devices such as HIV or hepatitis tests (class D) and certain influenza tests (class C), have a transition period until May 2025 and 2026, whilst lower risk ones such as class B and A sterile devices, have a transition period until May 2027.

No change is proposed for CE-marked devices that do not require notified body involvement under the IVD Regulation or for devices that are ‘new', i.e. devices that have neither a notified body certificate nor a declaration of conformity under the current Directive 98/79/EC. For those types of devices, the IVD Regulation will therefore apply from 26 May 2022 as planned.