IVDR Transition and Implementation: What Have We Learned from the MDR?

The EU IVDR became applicable as of 26 May 2022 and requires all IVDs on the European market to obtain new CE marking under the IVDR that contain many new requirements, in the majority of cases by conformity assessment by a notified body, thus radically changing regulatory requirements for IVDs in Europe. Many IVD manufacturers have taken a ‘wait and see’ approach to IVDR transition because not many notified bodies have been notified under the IVDR so far and implementation of the IVDR by the MDCG and European Commission is moving slowly with a focus on implementation of the MDR. This session will address how IVDR manufacturers can (and should be) more proactive in preparing for IVDR transition by leveraging guidance and regulatory knowledge already developed under the MDR, which overlaps to a large extent with the IVDR as regards regulatory principles such as technical documentation, clinical/performance evaluation, supply chain regulation, PMS and post-market performance follow-up and vigilance. Focus will be given not only to the regulatory challenges, but also to the opportunities it can bring when applying the learnings from the MDR rollout. Objective of the session is to create awareness for these opportunities and bringing the message that IVD manufacturers should not be shying away from applying these learnings in practice. Both the Notified Body side and Manufacturer side will be reflected.