In Vitro Diagnostic Regulation (IVDR)

The IVDR replaced the existing in vitro diagnostic medical devices Directive (98/79/EC) (IVDD). In terms of their impact on manufacturers and products, the IVDD and the IVDR largely share the same basic regulatory process. No existing requirements have been removed, but the IVDR adds new requirements. The IVDR brings more stringent requirements for the designation of Notified Bodies (NBs), with increased control and monitoring by the national competent authorities and the Commission.

The biggest change concerns the risk classification of in vitro diagnostic (IVD) devices and the role of NBs. The IVDD took a list-based approach to assigning risk classes, which in turn determined the process for assessing conformity and the level of supervision required from NBs. The IVDR instead uses rules recognized at international level to assign each device to one of the four risk categories, ranging from class A (lowest risk) to class D (highest risk). As a result, around 85% of all IVDs will need NBs oversight. For example, the conformity assessment of class D devices will require the involvement of an EU Reference Laboratory (if designated for that type of device) to verify the performance claimed by the manufacturer and compliance with the applicable Common Specifications. For innovative class D devices where no Common Specifications currently exist, an independent expert panel must provide its views on the performance evaluation report of the manufacturer.

The IVDR calls for increased transparency, with information on IVD devices and ‘higher risk’ performance studies being made public. The new European Database for Medical Devices (EUDAMED) will play a central role in providing more complete, accurate and accessible data. Additionally, the introduction of a unique device identifier (UDI) for every IVD device will significantly enhance traceability and support post-market safety activities.