Performance Evaluation

1. Scientific validity
1.1 Pre-Market

  • Scientific literature (peer reviewed)
  •  Consensual expert appraisals/expert statements from relevant specialist organizations
  • Results of proof of concept studies
  • Results from clinical performance studies

1.2 Post-Market-Surveillance (PMS)

  • Proactive data collection
  • Evaluation of performance data
  • Latest technology - state-of-the-art

2. Analytical performance
2.1 Analytical sensitivity

  • Detection and quantification limits (LoD, LoB, LoQ)
  • Linearity
  • Measuring range (defined by LoQ and linearity)

2.2 Analytical specificity

  • Cross-reactions (analytes with similar structures, such as precursors, metabolites, related organisms)
  • Interferences (hemoglobin, icteric, lipemic, RF +, HAMA, ...) 

2.3 Stability studies for assays and samples

  • Sample type, matrices, sample stability, storage conditions, freeze-thaw process
  • Calibration stability, onboard stability
  • Module and device precision

2.4 Trueness (distortion)

2.5 Precision

  • Repeatability (day-to-day measurement)
  • Reproducibility (laboratory and user)

2.6 Accuracy (as a result of trueness and precision)

3. Clinical Performance Evaluation
3.1 CTS/CS

  • Diagnostic sensitivity
  • Diagnostic specificity
  • Positive predictive value
  • Negative predictive value
  • Likelihood ratio
  • Expected values ​​in affected and unaffected population groups

3.2 Near-Patient Testing (NPT)

  • Conformity assessment according to Annexes IX to XI IVDR
  • Evaluation of the technical documentation

3.3 Lay studies
To apply for special approval for an in-vitro diagnostic test for self-use by laypeople

Customer Specific Solutions

1. Operation of COVID-19 rapid test centers

  • Planning and implementation
  • In accordance with the requirements of the Covid Occupational Safety and Health Ordinance (current version)
  • on their company premises within Germany

2. External study site

  • Implementation of clinical performance evaluation studies
IVDR Conformity / CTS

Implementation of the IVDR requirements

  • Classification of the product
  • Definition of certification tasks
  • Support during the conformity assessment procedure
  • Unique Device Identification (UDI)
  • GAP analysis
  • Technical documentation
  • Post-Market-Surveillance (PMS)
  • Communication with notified bodies
Prospective Sampling

Prospective sample collection

  • Provision of precisely defined samples for conducting prospective studies
  • Quantitative and qualitative documentation of the prospective samples in compliance with the analytical and serological requirements of the tests
  • Supply of bulk material
  • Human samples at various stages of infection available for antibody detection (seroconversion panels)

IVDR Conformity / CTS

Since May 25, 2017, the EU Directive 98/79/EC has been replaced by the European Regulation for In Vitro Diagnostics (IVDR for short). Unlike the medical devices regulation (MDR for short), which must be implemented from May 2020, the IVDR will only be mandatory after a five-year transition period.
But this time buffer is shorter than it appears at first sight. Those who do not take care of the necessary validations, performance evaluations and documentation now will not be able to commercialize their diagnostics in compliance with the law as of May 26, 2022. The regulation makes no distinction between new products and diagnostics that have already been launched on the market, i.e. de facto no grandfathering is permitted, so that manufacturers need to assess, check and, if necessary, validate all products for their risk class.

Biomex GmbH offers support and a wide range of services and reference samples for the timely and standard-compliant implementation of the IVDR specifications:

  • Classification of your products and defining of the resulting requirements and certification tasks
  • More than 500,000 human biological samples for the validation and quality control of your assays and sera
  • Communication support with the notified bodies required for accreditation as well as support during the conformity assessment procedure
  • Planning and implementation of a specific unique product identification number (UDI) for the secure traceability of a product within the supply chain
  • External implementation of studies or internal support to prepare any required clinical studies
  • Support to adapt the technical documentation according to IVDR specifications, including continuous performance evaluations

Contact us!