- Lee Ould
A Welcome Reprieve from the New IVD Regulation (IVDR)
The new IVDR originally was to come into force in its entirety on May 26, 2022, but since 2020 and through present (2022) there has been a push by manufacturers and industry for a reprieve, due to issues with limited Notified Bodies under the new Directive, and the impact of Covid. Following an EU Commission proposal in October 2021, the transitional provisions were intended to extend the dates for certain classes of products. Importantly, many products under the current IVD Directive that are not under Notified Body evaluations are allowed to remain under that scheme, if so compliant at the May 26, 2022 date. Class D devices will be required to be under the IVDR on May 26, 2025, Class C on that date in 2026, and Class B on that date in 2027. Technically the IVDR is still coming into effect on the 2022 date, but the more challenging requirements will be delayed as noted. The decision was based on the considerable increase in manufacturers that are now under the EU's requirements for Notified Body involvement (estimated 80% vs a previous 8%), the increased role of the Notified Bodies in the IVDR, and the limited number of Notified Bodies that are accredited to those new IVDR requirements (only 6 vs 22). When SEL approached such accredited Notified Bodies in 2021, the quotes came back with starting dates in 2023, which was evidence for us of the need to delay, to be better prepared for these sweeping changes. Efforts to refine this transition are still evolving with decisions ongoing at the time of this post.