Performance evaluation of IVDs

The performance evaluation is a central process that accompanies the entire life cycle of an in-vitro diagnostic medical device (IVD) and has numerous interfaces to other processes. It starts with the formulation of the intended purpose, continues during development, includes the risk-benefit assessment before a product is placed on the market for the first time, and continues during the continuous monitoring of the safety and performance of an IVD.

Fortunately, the IVDR contains much more detailed information on performance evaluation than the IVDD. However, these requirements have been state-of-the-art since 2012.

The performance evaluation experts at the Johner Institute will be glad to assist in the performance evaluation of your IVD assay, reagent kit, IVD software or IVD device.

Other things we can do for you

Strategy development for performance evaluation

• Based on the intended purpose of your IVD, we work with you to develop a strategy for presenting the clinical evidence for your product.
• We will work with you to create a product-specific performance evaluation plan in compliance with the requirements of Annex XIII of the IVDR

State of the art

• We perform systematic literature research for you to prove that your product is state-of-the-art.
• We help you to document your research in a traceable manner.

Scientific validity

• We carry out systematic literature searches to prove the scientific validity of the analyte.
• We help you to evaluate your literature research according to specified criteria and to document it in a comprehensible manner.

Analytical performance evaluation

• We plan analytical performance evaluation studies and draw up your analytical performance evaluation plan.
• We support you in conducting analytical performance evaluation studies.
• We prepare the report on the analytical performance in accordance with IVDR, Annex XIII, Part A.

Clinical performance evaluation

• With you, we develop a strategy for demonstrating the clinical performance characteristics of your IVD.
• We support you in the planning of clinical performance evaluation studies and write the clinical performance study plan according to ISO 20916 and IVDR, Annex XIII, Part A.
• We support you in conducting clinical performance evaluation studies (see also "Clinical Trials").
• We prepare the report on the clinical performance study as well as the report on the clinical performance according to IVDR, Annex XIII, Part A.

Follow up of performance after placing the product on the market (Post-Market Performance Follow-up (PMPF))

• We support you in continuously keeping the performance evaluation up-todate.
• We create product-specific PMPF plans as well as evaluation reports on the follow-up of the performance after placing the product on the market (PMPF report).
• We will assist you in conducting clinical performance studies after placing the product on the market.

Documentation

• We have developed a large number of templates for you which you can use to create the performance evaluation documentation for your IVD in less time.
• We support you in creating the performance evaluation file, thus helping you to help yourself.
• We check your planned approach, your performance evaluation file or individual documents for conformity with the requirements of the IVDD or IVDR.

With our help, this is what you will achieve

You will get your product onto the market more quickly.

• By carefully planning the performance evaluation strategy for your IVD, you can avoid time-consuming additions and expensive repetitions of your experiments and studies. This helps you generate sales with your product faster and avoid wasting time.

You will minimize the costs for creating the performance evaluation file

• Our templates provide you with the document structure and with valuable information on how to complete the documents. This reduces the work involved in documenting the performance evaluation of your IVD.
• We have experts in next generation sequencing, quantitative real-time PCR, reverse transcriptase PCR, immunoassays, lateral flow assays, immunology, tumor biology, cellular signal transduction and molecular genetics. Our training period in specific technical and scientific topics is therefore very short, lowering your costs.

You will accelerate your development and enjoy success with your products on the market.

• We are experienced developers in IVD software, IVD assays and IVD point-ofcare devices. Closely interlinking the development and performance evaluation process helps us solve problems before they arise.
• We are familiar with the medical laboratory field and thus the area in which most IVD products are used. This enables us to optimally evaluate the performance and safety as well as the risk-benefit ratio of your products. Analysis of the interfaces to the risk management process and to verify usability are essential.

Avoid stress in audit and approval.

• We have extensive experience in creating critical assessments to demonstrate the scientific validity of analytes, conducting analytical performance evaluation studies, planning prospective and retrospective clinical performance studies, and sample characterization requirements. Close cooperation with our Clinical Investigation team and biostatisticians experienced in diagnostic studies round off our profile.

Get in touch with us to ensure that your IVD's performance evaluation is compliant with the IVDR.