Description: On January 23rd 2024, the European Commission (EC) released a proposal to amend the current transitional provisions of the IVDR. This session will focus on the practical implications of the proposal and potential amendments, based on realistic timelines for appraisal of legacy device documentation, remedial actions, compilation of IVDR documentation, and review by the Notified Body. The session will make clear that the EC's proposal is not a free pass for manufacturers to 'sit back and relax', but rather a last boarding call for those who aim to get their products IVDR-compliant.
Learning Objectives:
Understand the difference between the current IVDR transitional provisions and the European Commission (EC)'s January 2024 proposal
Determine if their IVDR transition program is in sync with the current timelines or that entailed within the EC's proposal
Define what milestones should be reached by the current deadlines, if the EC's proposal is accepted
.jpg "Pieter Bogaert, PhD photo")