COMPLIANCE
manufacturers of in vitro diagnostics (IVDs) to align evidence generation with clinical relevance and regulatory expectations.
Gap between guidance and reality Annex XIII, Part A of the IVDR states: “Performance evaluation of a device is a continuous process by which data are assessed and analysed to demonstrate the scientific validity, analytical performance and clinical performance of that device for its intended purpose as stated by the manufacturer.”3 Meeting these requirements demands
clinical insight, strategic foresight, and operational agility in addition to technical capability. While the guidance outlines expectations, navigating the actual constraints that shape real-world evidence generation is an entirely distinct undertaking. For larger manufacturers with extensive portfolios of legacy devices, the shift to IVDR presents a significant operational burden. Many of these technologies were developed under previous frameworks, with limited access to prospective data or detailed performance documentation. Remediating hundreds of devices requires careful triage, resource planning and evidence prioritisation. This creates a structural challenge within organisations, testing operational agility and long-term planning.
As manufacturers work to align legacy documentation with IVDR standards, even foundational elements can reveal unexpected gaps. Scientific validity is often viewed as the most straightforward pillar of clinical evidence, particularly for well-established analytes supported by consensus and robust literature. However, MDCG 2022-2 highlights that gaps can still emerge when intended use changes, populations differ, or legacy data do not meet current expectations for demonstrating state-of-the-art, equivalence, or methodological rigor. In these cases, manufacturers may need to reassess comparator data, generate bridging evidence, or refine claims to
Point-of-care diagnostics introduce further considerations. Comparator studies conducted in controlled laboratory environments may not adequately reflect real-world use.
ensure alignment with the evidence base. When working with emerging
biomarkers, multi-analyte panels, or novel diagnostic targets, the clarity around scientific validity can fade quickly. In these cases, the evidence base may be limited, heterogeneous, or evolving, making it difficult to demonstrate state of the art or establish equivalence as required by MDCG 2022-2. Manufacturers must ensure that their sources reflect current clinical understanding and that comparator data are sufficiently detailed, peer-reviewed, and methodologically robust. This is especially important in fast-moving fields such as oncology, infectious disease, and genomics, where clinical relevance can shift rapidly and where gaps in evidence may require bridging studies or clearly defined limitations in performance claims. Compounding this complexity is
the tension between retrospective and prospective data. While prospective studies offer greater control and rigor, they are not always feasible. For rare diseases or legacy technologies, retrospective
datasets may be the only viable source, but MDCG 2022-2 emphasises that such data often lack the granularity needed to demonstrate equivalence or state of the art. This creates both logistical and ethical considerations, requiring manufacturers to balance feasibility with transparent communication of limitations and, where necessary, the generation of bridging evidence. Comparator data, central to
The rise of AI-enabled diagnostics, decentralised testing, and equitable diagnostic access
strategies demands new thinking – evidence must be relevant, inclusive, and iteratively refined
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WWW.PATHOLOGYINPRACTICE.COM September 2026
establishing the state of the art, introduces yet another layer of complexity. Under IVDR, equivalence is tightly constrained. Publicly available sources such as literature or marketing materials offer partial insights but often lack the depth needed to support robust performance claims, leaving a weak basis for comparison. This raises an important question: if the foundational data used for comparison are inadequate, can the resulting performance claims truly be considered reliable? Manufacturers must assess whether available data are current, clinically relevant, and methodologically sound. Where comparator data lack depth or alignment with the intended use, the regulations emphasise the need to generate bridging evidence or clearly articulate limitations to ensure a defensible performance claim. Beyond methodology, sample
availability and population diversity heavily influence feasibility. For novel biomarkers or low-prevalence diseases, assembling statistically robust cohorts is a persistent challenge. MDCG 2022-2 highlights that such constraints can limit the ability to demonstrate equivalence
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