Performance evaluation under IVDR

Performance evaluation is defined in Article 2 of IVDR as ‘an assessment and analysis of data to establish or verify the scientific validity, the analytical and, where applicable, the clinical performance of a device’. Therefore, the Regulation is describing the evaluation of three distinct sets of performance characteristics as they relate to its intended purpose. The critical point here is that the intended purpose must meet the elements listed in Annex I 20.4.1, and the classification has to be appropriate based on the specific disorder, condition or risk factor of interest that it is intended to detect, define or differentiate (Annex II 1.1(c) (iii)). The manufacturer needs to consider all aspects of the intended purpose statement when determining the approach for performance evaluation in addition to the requirements of the Regulation as illustrated in Figure 1.

Understanding how to classify your device can depend on the disorder or condition your device is intended to diagnose as the manufacturer has to understand the risk to the patient or public health as a whole through misdiagnosis or misuse. This is a significant change from IVDD as the Directive defined classification by condition name, based on what was perceived as a high-risk device at that time. IVDR does not make that distinction other than for blood grouping reagents in Annex VIII. This has led to the majority of IVDs that were placed on the market after 1998 being classed as self-declared (which presents other challenges as discussed later in this paper). MDCG 2020-16 Guidance on classification rules for in vitro diagnostic medical devices under Regulation (EU) 2017/746 provides further classification guidance for IVDR and specific examples for reference.

Clinical evidence is defined in Article 2 of the Regulation as ‘clinical data and performance evaluation results, pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s), when used as intended by the manufacturer’. So, the definition of clinical evidence suggests a risk-based approach to defining the clinical benefits, and ultimately the requirements for the device, determined by the intended purpose, classification and risk management. Therefore, the manufacturer would consider the performance evaluation requirements for a Class A specimen receptacle very differently to a Class D HIV assay. A fully detailed understanding of intended purpose and clinical use of the device is required at an early stage of product development in order to correctly define design inputs as they relate to performance evaluation.

Performance evaluation should be a part of the quality management system for an IVD. BS EN ISO 13485:2016 describes the requirements to define performance in design inputs as part of the design and development process and conducts performance evaluation as part of design validation in accordance with applicable regulatory requirements. Therefore, the concept of conducting performance evaluation is not new to IVD manufacturers, but they are required to adapt to the new elements now included within IVDR in order to place their device on the market in the EU. Figure 2 illustrates how performance evaluation requirements should be defined very early in the design of the device and how each step of the process should inform how the next step is approached.

This is an excerpt from the forthcoming white paper Performance evaluation under IVDR. To download our other medical device white papers, please visit the Insight page on the Compliance Navigator website.