The In Vitro Diagnostic Regulation (IVDR) represents a major shift in the regulatory landscape for IVD manufacturers, placing significant emphasis on the need for solid clinical evidence to support the analytical and clinical performance of the assays including the scientific validity of the analytes or markers they detect or quantify. This is a departure from the previous framework, where the importance of clinical data was not as extensively outlined. Under the IVDR, clinical evidence is the foundation upon which a successful regulatory submission is built.
At the heart of the IVDR’s new requirements is Chapter VI, which is entirely dedicated to clinical evidence. In particular, the regulation introduces a new and critical concept of scientific validity, which, alongside analytical and clinical performance, forms the three essential pillars of a solid clinical evidence strategy.
Why is clinical performance so crucial?
The most obvious answer should be that unless clinical performance is solidly supported by data, an IVD manufacturer cannot be sure of the robustness of its products. However, a more pragmatic reason is that Notified Bodies are now rigorously scrutinizing clinical evidence as part of their review of technical documentation. A significant portion of deficiencies identified in technical files submitted for IVDR certification are directly related to gaps in clinical data. In many cases, these deficiencies are linked to poorly defined or unclear intended purposes (IP) for the diagnostic assays. If the intended purpose is vague or inadequately defined, it becomes nearly impossible to gather robust clinical evidence, leading to significant delays or rejections during the submission process.
This underscores a critical message for IVD manufacturers: a clear and precise intended purpose is essential to generating credible clinical evidence. Without it, even the most advanced assays may fall short in the eyes of regulatory bodies. Thus, manufacturers must ensure that their intended purposes are not only clearly articulated, but also aligned with the clinical claims they are making.
The role of Clinical Performance in a smooth IVDR Submission
Clinical performance demonstrates that an assay delivers reliable and meaningful results in its intended setting, whether it be a laboratory, near-patient testing, or self-testing device. This aspect of clinical evidence becomes even more critical when considering how stringent IVDR has become in its evaluation of performance studies. For manufacturers, understanding and planning for these performance requirements from the outset is paramount to avoid delays or rejections in the approval process.
At QbD Group, we have witnessed firsthand how a proactive and comprehensive approach to clinical evidence can significantly smooth the IVDR submission process. In particular, the Qarad experts at QbD, have leveraged their years of expertise to help IVD manufacturers refine their clinical performance strategies and navigate the complexities of performance studies.
The experience our experts have accumulated shows that triple-checking clinical evidence—from the intended purpose of the device to the study design and data collection—can make all the difference. By ensuring that the clinical evidence provided is robust, complete, and aligned with regulatory expectations, manufacturers can reduce the risk of deficiencies being flagged by Notified Bodies.
Support for IVD manufacturers
Our upcoming webinar, “Mastering Clinical Performance Studies under IVDR – From Strategy to Delivery,” is designed to equip IVD manufacturers with the knowledge and tools they need to ensure a smooth transition to IVDR compliance. We will delve into the critical aspects of clinical performance, offering insights and guidance from defining your clinical strategy to meeting ISO 20916 requirements and conducting usability studies for near-patient and self-testing devices.
Our team of experts will share strategies for:
- Defining a strong clinical performance strategy tailored to your assay.
- Understanding the regulatory requirements for clinical performance studies, including those under ISO 20916.
- Navigating the complexities of Annex XIV compliance.
- Conducting effective usability studies for near-patient and self-testing devices.
Whether you are at the beginning of your IVDR submission process or seeking to refine your strategy, we are here to help you master the clinical performance requirements and avoid common pitfalls.