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European Commission has proposed a progressive roll-out of the new In Vitro Diagnostic Medical Devices Regulation to prevent disruption in the supply of these essential healthcare products. The unprecedented challenges of the COVID-19 pandemic have diverted resources from Member States, health institutions and economic operators towards addressing the crisis, thereby hampering the capacity to comply on time with the changes introduced.
“The COVID-19 pandemic has shown how essential it is to have accurate diagnostics and a robust regulatory framework for in vitro medical devices. Shortages at this point in time are unthinkable,” Stella Kyriakides, Commissioner for Health and Food Safety, said in a statement.
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.
The IVD Regulation introduces substantial changes in the regulatory framework for in vitro diagnostic medical devices, such as HIV tests, pregnancy tests or SARS-CoV-2 tests.
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.
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.