On 26 May 2022 Regulation (EU) 2017/746, the In Vitro Diagnostic Regulation (IVDR), became applicable, replacing the IVD Directive that had governed diagnostics in Europe since 1998. The shift is large: under the Directive around 80% of IVDs were self-certified, while under the IVDR the risk-based classes B, C and D require notified-body conformity assessment.
The transition timelines
Regulation (EU) 2022/112, adopted in January 2022, staggered the deadlines for legacy devices by class to relieve notified-body capacity: class D to 2025, class C to 2026 and class B and A sterile to 2027, provided the devices were already CE-marked under the Directive and no significant changes are made.
Work that lands on regulatory and quality teams
- Performance evaluation reports covering scientific validity, analytical and clinical performance, with post-market performance follow-up plans.
- UDI assignment and registration as EUDAMED modules become available.
- Quality management system updates to ISO 13485:2016 with IVDR-specific procedures for vigilance and PMS.
- Economic operator obligations for importers and distributors.
Where Vakula helps
We have placed regulatory writers and quality engineers with IVD manufacturers preparing technical documentation under the IVDR, and we provide audit support ahead of notified-body reviews. See regulatory affairs.