Performance Evaluation

Performance evaluation is the central document for providing clinical evidence for your product and demonstrating that the product complies with the general safety and performance requirements in line with its intended purpose. The clinical evidence consists of scientific validity, analytical performance, and clinical performance. Additionally, the performance evaluation takes into account data from risk management and post-market surveillance (PMS).
For this purpose, we work closely with you to develop a detailed performance evaluation plan, prepare the necessary reports on scientific validity, analytical performance, and clinical performance, and carry out the performance evaluation for your product.

Puzzle IVDR Konformität

The performance evaluation is closely connected to other regulatory documents such as the PMPF report (Post-Market Performance Follow-Up) or the SSP (Summary of Safety and Performance). Through careful planning and coordination, we ensure that all regulatory requirements are met and that any resulting synergies are leveraged as efficiently as possible.

Performance Evaluation Plan

Good planning is the key to success – and this also applies to performance evaluation. A thoroughly designed and structured performance evaluation plan (PEP) provides the basis for an efficient performance evaluation strategy for your product.

In the case of new product development, a PEP helps to clearly define development goals and ensure that all relevant parameters are evaluated. For existing products, the PEP facilitates the identification of outstanding issues, which can then be addressed through PMS and PMPF activities.

We offer you:

Identification and evaluation of available data for your product
Definition of parameters for evaluating analytical and clinical performance
Strategy development and gap analysis regarding potential data gaps

Scientific Validity

Scientific validity describes the relationship between an analyte with a specific clinical condition or physiological state.

Even for products that were already marketed under the IVDD, this relationship must be demonstrated and documented under the IVDR. Various sources can be used for this purpose, such as information on the scientific validity of devices measuring the same analyte or marker, scientific literature, expert opinions, and results from proof-of-concept studies or clinical performance studies. For many analytes, scientific validity is already well established. In such cases, evidence can typically be provided through a systematic literature review. For novel analytes, where the relationship with a specific clinical condition or physiological state is not yet well established, a clinical performance study may be necessary to demonstrate scientific validity.

novineon CRO prepares the report on scientific validity for you, which also serves as a cornerstone of performance evaluation.

Systematic and reproducible literature search on scientific validity and state of the art
Summarizing and evaluating all available data in line with current regulatory requirements
Presentation of physiological relationships and state of the art based on identified sources

Analytical Performance

Analytical performance refers to a product's ability to correctly detect or measure a specific analyte. It is assessed using parameters such as analytical sensitivity, specificity, or reproducibility.

novineon CRO summarizes the results of your analytical performance studies and prepares the analytical performance report, providing an additional pillar of performance evaluation.

Definition of parameters for assessing analytical performance
Summary of all available analytical performance data for your product
Evaluation of potential gaps in demonstrating analytical performance

Clinical Performance

Clinical performance describes a product's ability to achieve correct results when used as intended – that is, how accurately the product captures physiological or pathological processes or conditions in a specific target population and among intended users.

Data from clinical performance studies, scientific literature, or published experience gained by routine diagnostic testing can be used to demonstrate the clinical performance of your product. These data are summarized and evaluated in the clinical performance report, which represents the third pillar of performance evaluation.

novineon CRO prepares the clinical performance report for you:

Methodologically sound, systematic, and reproducible literature search on clinical data
Clear documentation of the literature search and its outcomes
Summary and evaluation of clinical data for your product

Conducting the Performance Evaluation

The goal of performance evaluation is to systematically assess and document the safety and performance of a product, ensuring it fulfills its intended medical purpose and maintains a positive benefit-risk ratio. The performance evaluation report (PER) summarizes and evaluates data on scientific validity, analytical performance, and clinical performance, as well as data from risk management and post-market surveillance.

Demonstrating scientific validity and clinical performance can, among other methods, rely on a systematic literature review. Additionally, conducting a literature search early in product development is recommended to determine the risk profile and state of the art based on comparable products.

With the introduction of the IVDR, both the documentation of the literature search and the appraisal of individual literature sources (data appraisal) have become significantly more important. At novineon CRO, we have developed an approach that minimizes documentation effort while ensuring clarity and traceability.

Risks identified through clinical data are reconciled with the risk analysis and the instructions for use of the product. Any open questions regarding clinical evidence or the benefit-risk ratio are addressed and can be resolved, for example, through future PMPF measures.

The IVDR requires manufacturers to regularly review and update the performance evaluation of their product to incorporate new scientific findings and data from PMS and PMPF. The frequency of updates depends, among other factors, on the risk class of the product and the nature and severity of identified risks.

Assessment of the product’s safety and performance
Evidence of compliance with GSPRs and provision of clinical evidence
Review of the consistency of technical documentation

Summary of Safety and Performance

For Class C and D products, manufacturers are required by IVDR to prepare a summary of safety and performance (SSP). The SSP serves to directly inform intended users and relevant patients and must be made available to the public.

The SSP includes information on the intended purpose and indication, risks and warnings, as well as a summarized presentation of the performance evaluation. If the product is intended for self-use, the SSP should be written in language understandable to laypersons and take into account the age of the target group. If the product is not intended for self-use, the SSP should be directed at professional users. However, such SSPs may also include sections understandable to laypersons, for patients, if deemed important by the manufacturer.

Preparation of the SSP according to MDCG 2022-9
Efficient summary of the performance evaluation
Layperson-friendly wording