SVR stands for Scientific Validity Report, a mandatory document for an In-Vitro Diagnostic (IVD) Device. SVR features the association of an analyte with a clinical condition or a physiological state. The association justifies the whole process of an IVD development and production, to demonstrate general safety and performance of an IVD.
What Legal Basis Does an SVR Require?
The requirements for the Scientific Validity Report (SVR) are defined in In-Vitro Diagnostic Regulations (EU) 2017/746; definition 38 of Article 2 defines the Scientific Validity and definition 48 of the same article defines the Performance Evaluation. The performance evaluation of an IVD is defined as, “assessment and analysis of data to establish or verify the scientific validity, the analytical and, where applicable, the clinical performance of a device”.
What are the Key Considerations for Developing SVR?
There are various aspects to be considered while developing an SVR, such as:
- The scientific validity demonstrated shall be in line with the analytical and clinical performance sections of the Performance Evaluation Report (PER)
- The scientific validity of an IVD is not a one-time activity and requires continuous confirmation throughout the lifecycle of an IVD
- Required literature search shall be carried out based on pre-defined literature search and selection protocols, captured in literature selection tables and compiled in literature search and selection report
- Revision cycle with the customer to further guarantee that the scientific validity is adequately established
- Scientific validity shall ensure continued acceptability of the benefit-risk ratio and of detecting emerging risks on the basis of factual evidence
- A combination of scientific, clinical and Regulatory knowledge along with good writing skills are required for collecting necessary information, screening and evaluation of data followed by compilation of an SVR
What are the Different Sources of Information for Compiling SVR?
The manufacturer shall demonstrate scientific validity of an IVD based on the information available from various sources, such as:
- Relevant information on the scientific validity of devices measuring the same analyte or marker
- Scientific (peer-reviewed) literature
- Consensus expert opinions/positions from relevant professional associations
- Results from proof-of-concept studies
- Results from clinical performance studies
The validity of the analyte or marker inferenced from the above sources should be demonstrated and documented in the scientific validity report.
What is the Step-By-Step Process for Compiling SVR?
The gathering of necessary information and compilation of a Scientific Validity Report involves a systemic step-by-step process as detailed below:
- Evaluate intended purpose of an IVD and determine the valid scientific claims
- Systemic literature search of peer-reviewed literature and other sources listed above for each of the determined scientific validity claim
- Screening of the literature search results, evaluation of the literature
- Once all the relevant information is gathered, the report shall be developed in a structured format
- Compilation of the scientific validity report
As a part of Performance Evaluation Report (PER) services, Freyr delivers EU IVDR compliant Scientific Validity Reports as a standalone service. To know how Freyr assisted a French-based client to submit high-quality SVRs to Notified Bodies, in a short span of one month, download the proven Case here. Would you like to know more about Freyr’s specialized expertise in SVR? Reach us at firstname.lastname@example.org for comprehensive insights.