With the advent of EU Regulation 2017/746 (commonly known as the EU IVDR), the introduction of Scientific Validity Reports (SVR) has become a pivotal and mandatory element within the regulatory landscape. SVRs play a vital role in the conformity assessment process, aiding manufacturers in obtaining CE marking and ensuring regulatory compliance. Under the IVDR, manufacturers are mandated to furnish evidence of the scientific validity, analytical, and clinical performance of their devices.
Understanding Scientific Validity Reports (SVRs)
Scientific validity of an analyte means the association of an analyte with a clinical condition or a physiological state. These reports provide evidence to demonstrate the reliability, accuracy, and clinical relevance of diagnostic tests. The SVR process entails meticulous collection and analysis of data from diverse sources, including published literature, clinical studies, and post-market surveillance data.
Regulatory Framework and Considerations
Regulation 2017/746, Annex XIII, 1.2.1 elucidates the requirements for SVRs under the IVDR. For certain Class A devices or controls and calibrators, scientific validity may not be required to support clinical evidence. In cases where these devices do not directly perform the assay, the Performance Evaluation Plan (PEP) must delineate that although scientific validity is not applicable for this device type, the scientific validity from the associated assay remains valid. Consequently, manufacturers solely placing controls or calibrators on the market are obligated to furnish a Scientific Validity Report (SVR) delineating the association of the analyte for the assay(s) they support. This ensures adherence to regulatory requirements and maintains the integrity of diagnostic processes.
For well-established assays, reliance on clinical guidelines or published literature may suffice, while newly developed assays necessitate additional evidence, such as proof-of-concept studies or clinical performance studies.
Sources of data for establishing Scientific Validity
The scientific validity of IVDs is substantiated by various sources of evidence, including -
Proof-of-concept studies
Clinical performance studies
Data on similar devices
Peer-reviewed literature
Expert guidance
Step-By-Step Process for Compiling SVRs
Conducting a systematic literature review is a cornerstone of the SVR process. It involves systematically searching, screening, and evaluating peer-reviewed literature to gather relevant evidence supporting the scientific validity claims of the IVD.
Step 1: Define Scope and Intended Use Begin by clearly defining the scope of the SVR and articulating the intended use of the IVD. Establish specific scientific validity claims relevant to the diagnostic capabilities of the device.
Step 2: Develop a Scientific Validity Plan (SVP) Craft a detailed Scientific Validity Plan (SVP) outlining the methodology and approach for the SVR. Define inclusion criteria, search parameters, data sources, and criteria for evaluating evidence.
Step 3: Create a Literature Search and Selection Protocol (LSSP) Develop a comprehensive Literature Search and Selection Protocol (LSSP) based on the SVP. Document the systematic search methodology, including databases to be queried, search strings, and criteria for article selection.
Step 4: Conduct Systematic Literature Review Execute the systematic literature review according to the parameters outlined in the LSSP. Conduct rigorous searches across relevant databases, screen identified articles for relevance, and extract pertinent data from selected studies.
Step 5: Evaluate Evidence Critically evaluate the gathered evidence to assess its relevance, quality, and applicability to the scientific validity claims of the IVD. Consider factors such as study design, sample size, and methodological rigor.
Step 6: Draft the Scientific Validity Report (SVR) Compile the findings of the literature review into a structured Scientific Validity Report (SVR). Clearly document the evidence supporting each scientific validity claim, providing references, justifications, and conclusions.
Step 7: Review and Revision Cycle Engage in a review and revision cycle with stakeholders to ensure the SVR accurately reflects the scientific validity of the IVD. Solicit feedback, address any concerns or discrepancies, and refine the report as necessary.
Challenges and Considerations
Developing scientifically valid SVRs can be complex and resource-intensive for manufacturers. Challenges may arise in designing appropriate study protocols, sourcing sufficient clinical data, and navigating regulatory requirements. However, investing in robust scientific validity assessments is essential for ensuring the reliability and efficacy of IVDs in clinical practice.
Analyte Claims | Condition Claims | Testing Population Claims |
Each analyte should be clearly enumerated along with distinct literature or data validating its association with the specified conditions. |
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Scientific validity reports are indispensable tools for demonstrating the accuracy, reliability, and clinical relevance of IVDs under the EU IVDR. Manufacturers must prioritize the development of comprehensive SVRs to obtain regulatory approval and ensure patient safety. By adhering to rigorous performance evaluations and clinical studies, manufacturers can navigate the regulatory landscape effectively and bring high-quality diagnostic tests to market.
Would you like to learn more about preparing scientific validity reports for your IVDs under the EU IVDR? Contact us today to discover how Artixio can support your regulatory compliance efforts and streamline the conformity assessment process.
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