ARTICLE SUMMARY:
The proposal from the European Commission doesn't address completely new tests, which will still need to meet IVD Regulation requirements beginning May 26, 2022. But tests that have been self-certified before that date that will require a notified body assessment under the IVDR will have an extra three-to-five years to comply depending on risk class.
The European Commission came through October 14 with a proposal to revise the IVD Regulation that has been widely hoped-for by the diagnostics industry. Now EU lawmakers need to approve it to make it a reality.
