February 9, 2022
European Commissioners updated their implementation plans for the In-Vitro Diagnostic Medical Devices Regulation (IVDR) with a stronger focus on risk management and contingency planning in the event of IVD supply shortages after the Regulation takes full effect.
The updated Joint Implementation Plan for the IVDR states more clearly than in its previous version in late 2021 the need for risk mitigation efforts in order to avoid major IVD supply disruptions to the European market. The scope of the IVDR affects significantly more types of IVD devices than the current European In-Vitro Diagnostic Medical Devices Directive (IVDD), and only six Notified Bodies so far have received designation to issue CE Mark certifications under the IVDR versus 19 Notified Bodies currently designated under the IVDD.
Elevating contingency planning and monitoring to the MDCG level
Previously, the IVDR Joint Implementation Plan’s “Contingency planning and monitoring” section included the formation of a forum whereby European Union member states can address challenges and risks as the new Regulation is rolled out over the next few years.
Under the updated plan, the European Commission has elevated these discussions to the level of the Medical Device Coordination Group (MDCG), tasked with ensuring harmonized implementations of the IVDR as well as the Medical Devices Regulation (MDR) across the EU. Specific recommendations for the MDCG’s course of action include:
- Discussing overall progress regarding transition from the IVDD to the IVDR
- Analyzing systemic risks to IVD device availability in the EU market
- Identifying solutions for risk mitigation, such as reprioritizing of work/action items, reallocation of resources and emergency guidance
Furthermore, the updated IVDR Joint Implementation Plan notes that the MDCG may also perform targeted market monitoring for particular IVD products in order to prevent or mitigate shortages.
“To tackle these issues, the MDCG must engage in discussion more frequently than it has done so far,” states the updated plan.
Staggered transition from IVDD to IVDR
European Commissioners’ recommendations for a more active role of the MDCG for IVDR implementation comes in conjunction with previously announced plans for a phased transition to the new Regulation to minimize potential EU IVD market disruptions. As a reminder, while the May 26, 2022 date of application for the IVDR still stands for IVDs classified as Class A self-certified under the new Regulation, the following deadlines now apply for full transition from the IVDD to the IVDR:
- May 26, 2025 for devices considered IVDR Class D
- May 26, 2026 for devices considered IVDR Class C
- May 26, 2027 for devices considered IVDR Class B and Class A sterile
Emergo by UL will provide additional IVDR updates from EU regulators as they become available.
Additional European IVDR compliance resources:
- European Authorized Representative in-country representation
- IVDR readiness checklist for manufacturers
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