IVDR Transition: Quo Vadis? – the current reality

Description: The aim of the IVDR transition amendment (EU)2022-122 was to allow full implementation of the IVDR and avoid potential market disruption. With the MDR deadlines likely being amended, attention will turn to the staggered transition under IVDR Article 110(3). The main aim of amending the IVDR transition to have risk-based deadlines was to prevent IVD device shortages, starting from 2025 for Class D devices. New to market IVDs and those that are Class A should be placed on the market under the IVDR since May 2022.

Whilst many guidelines have been published to provide clarity for the way forward, larger corporations and small manufacturers are experiencing very different challenges. Critical infrastructure is still being implemented, such as the EU Reference Laboratories (EURLs) that are needed for conformity assessment of Class D devices. A guidance from the MDCG (MDCG 2022-14) published in Aug-2022 provided an outline of possible focus areas to support effective and timely transition to MDR and IVDR. A number of suggestions in the guidance require a different approach for IVDs compared to other medical devices (such as NB capacity for IVDs, or reliance on legacy data), due to the difference in transitioning from the IVDD to IVDR, compared to the old Directives and MDR. A year on from the publication of the MDCG 2022-14 guidance, as well first experiences with changes under Art 110.3, this panel discussion will focus on the practical reality of whether the amended transition of the IVDR and further measures to support the regulatory framework will allow all safe and effective IVDs to be certified in time. The panel will also discuss whether the IVDR transition timelines is affecting regulatory strategy and new product launches; is market access of new and innovative devices being impacted.

This session will hear from a range of stakeholders and their experiences: Notified Bodies (established and newly designated), manufacturers, national authorities as well as consultants will delve into how the changes to the IVDR have impacted all stakeholders. They will discuss the practical status of IVDR implementation and considerations for manufacturers in planning their IVDR transition with the staggered deadlines.

Following the panel discussion, there will be a Q&A.