Scientific validity is a core requirement under the Regulation (EU) 2017/746 for all in vitro diagnostic (IVD) devices. It is one of the three pillars of Performance Evaluation, alongside analytical performance and clinical performance. As defined by Regulation (EU) 2017/746 i.e. EU IVDR, the ‘scientific validity of an analyte’ is the association of an analyte with a clinical condition or a physiological state and as per the definition of Scientific validity given in MDCG 2022-2: ‘scientific validity’ means the extent to which the analyte, or marker to be determined by the IVD is associated with the targeted physiological state or clinical condition. In line with Annex XIII, Part A, Section 1.2.1 of Regulation (EU) 2017/746, our Regulatory experts support the manufacturers in demonstrating scientific validity based on one or a combination of the following sources, as relevant, including:
- 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;
Maven offers expert, end-to-end support for the preparation and submission of scientific validity documentation, helping IVD manufacturers achieve clear, consistent, and audit-ready compliance with EU IVDR requirements and Notified Body expectations.
Under the IVDR, scientific validity is typically structured through the following documents:
- Scientific Validity Protocol
- Scientific Validity Report
Scientific Validity Protocol (SVP)
The Scientific Validity Protocol (SVP) is a planning document that defines the approach for establishing, evaluating, and documenting the characteristics and performance of the device and the process and criteria to generate the necessary clinical evidence in accordance with EU IVDR requirements. It ensures a systematic and transparent assessment by outlining a predefined methodology for the identification, collection, and evaluation of relevant clinical evidence and serves as the foundation for the subsequent Scientific Validity Report.
Maven supports manufacturers in the preparation of EU IVDR-compliant Scientific Validity Protocols tailored to the specific device, intended purpose, and risk class. Our experts develop robust, well-justified methodologies aligned with Annex XIII of Regulation (EU) 2017/746 and MDCG 2022-2 expectations, ensuring clear traceability between scientific evidence and performance claims. By proactively addressing common Notified Body expectations at the protocol stage, Maven helps minimise evidence gaps, reduce rework, and facilitate efficient and timely conformity assessments.
The SVP includes,
- Device details and intended purpose
- Description of analyte and clinical condition
- Types of scientific evidence considered
- Data evaluation methodology
- Performance Claims
Scientific Validity Report (SVR)
The Scientific Validity Report (SVR) documents the results, analysis, and conclusions of the scientific validity assessment conducted in accordance with the approved Scientific Validity Protocol. It provides objective and traceable evidence that the relationship between the analyte and the associated clinical condition or physiological state is scientifically established and supports the device’s intended purpose.
The SVR plays a key role within the Performance Evaluation framework and is a key input into the Performance Evaluation Report (PER). During EU IVDR conformity assessments, Notified Bodies closely review the SVR to assess the adequacy, relevance, and scientific robustness of the evidence base, ensuring that the claimed performance of the device is appropriately justified and supported by available clinical evidence.
How Maven Supports the Preparation of a Scientific Validity Report
Maven prepares comprehensive and well-structured Scientific Validity Reports (SVR) based on the critical evaluation of all relevant scientific evidence mentioned in SVP. We identify potential evidence gaps at an early stage and support IVD manufacturers in addressing them through appropriate justification or additional supporting data. Our team ensures full consistency and traceability between the SVR, performance claims, and the Performance Evaluation Report (PER), and provides targeted support for post-assessment updates in response to Notified Body feedback.
Lifecycle Management of Scientific Validity
Scientific Validity under EU IVDR is not a one-time activity; it is an integral part of the performance evaluation that must be maintained throughout the entire life cycle of an in vitro diagnostic device.
Maven also supports manufacturers through an Annual Maintenance Contract service, which shall ensure that Scientific Validity documentation is continuously maintained throughout the lifecycle of the IVD, fully integrated with overall performance evaluation activities. This ongoing support helps manufacturers remain compliant with EU IVDR requirements by proactively incorporating new scientific developments and regulatory expectations throughout the device life cycle.
Our Expertise
As a regulatory consultancy, we support manufacturers in establishing and maintaining scientifically robust and EU IVDR-compliant scientific validity documentation. Our approach combines deep regulatory knowledge, strong scientific expertise, and practical experience with IVDR conformity assessments.
Why Choose Us?
- Backed by over 10 years of regulatory experience, we help medical device manufacturers efficiently achieve CE certification and meet EU MDR and IVDR requirements.
- Deep expertise in EU IVDR and performance evaluation, including Scientific Validity, analytical and clinical performance
- Scientifically robust, well-structured, and audit-ready documentation aligned with Notified Body expectations
- Practical, efficient, and risk-based regulatory solutions tailored to your device and business needs
- Lifecycle-oriented compliance support, integrating Scientific Validity with PMS, PMPF, and ongoing regulatory updates.
For further information on Scientific Validity, refer to the following documents:
FAQ:
Scientific Validity is the documented evidence demonstrating that a specific analyte or biomarker is associated with a particular clinical condition or physiological state. Under Regulation (EU) 2017/746 (IVDR), Scientific Validity forms one of the three pillars of Performance Evaluation, alongside Analytical Performance and Clinical Performance. Manufacturers must establish this association using scientifically sound and objective evidence before placing an IVD device on the market.
Yes. Scientific Validity is a mandatory requirement for IVD devices that provide information related to a clinical condition or physiological state. Manufacturers must demonstrate and document this association as part of the Performance Evaluation process. The requirement applies throughout the device lifecycle and is reviewed during conformity assessments by Notified Bodies.
Scientific Validity is demonstrated through a structured evaluation of scientific and clinical evidence in accordance with Annex XIII of Regulation (EU) 2017/746. Evidence may include peer-reviewed literature, clinical performance studies, proof-of-concept studies, expert consensus publications, and data from equivalent devices. The assessment methodology is defined in the Scientific Validity Protocol (SVP), and the conclusions are documented in the Scientific Validity Report (SVR).
The Scientific Validity Protocol (SVP) is the planning document that defines how scientific evidence will be identified, collected, assessed, and documented. The Scientific Validity Report (SVR) contains the results, analysis, and conclusions of that assessment. Together, these documents provide objective evidence supporting the relationship between the analyte and the intended clinical condition.
Yes. Scientific Validity is a fundamental component of Performance Evaluation under EU IVDR. It establishes the scientific basis for the device’s intended purpose and supports the justification of performance claims. Scientific Validity, Analytical Performance, and Clinical Performance collectively demonstrate that an IVD device is safe and performs as intended.
Maven helps IVD manufacturers prepare IVDR-compliant Scientific Validity documentation, including Scientific Validity Protocols (SVP), Scientific Validity Reports (SVR), literature evaluations, and evidence gap assessments. Our experts ensure alignment with Annex XIII requirements, MDCG guidance documents, and Notified Body expectations while maintaining consistency with the Performance Evaluation Plan (PEP) and Performance Evaluation Report (PER).
