Framework
EUIVDR — Classification
The EU IVDR 2017/746 establishes a risk-based classification system for IVD medical devices across four classes (A, B, C, D), replacing the list-based approach of the former IVD Directive. Annex VIII defines seven classification rules based on the intended purpose of the device, the risks associated with incorrect results, and the impact on individual patients and public health.
Overview
Background
Under Regulation (EU) 2017/746, the classification system for IVD devices was fundamentally redesigned from the list-based system of the IVD Directive (98/79/EC) to a risk-based approach. This change was one of the most significant aspects of the new regulation, as it reclassified the majority of IVD devices from self-certification to notified body involvement, substantially increasing regulatory oversight across the sector.
Applicability
These classification rules apply to all IVD medical devices intended for the EU market. Manufacturers must determine the correct classification for each device before initiating the conformity assessment process. The classification determines which conformity assessment procedure applies and whether a notified body must be involved. Class A devices may self-certify (with exceptions), while Class B, C, and D devices require progressively greater notified body involvement.