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)

GAP Analysis

With the new IVDR, stricter requirements for performance evaluations will apply from May 26, 2022, particularly with regard to technical documentation and vigilance.

For meeting the new requirements of the IVDR, the performance records of existing products may need to be significantly updated. For this reason, manufacturers should carry out a so-called GAP analysis, i.e. a comprehensive, systematic actual/target comparison, in order to identify gaps in the performance records of products currently on the market and the new regulations.

Biomex GmbH supports manufacturers in the planning and implementation of the required GAP analyses - contact us!


Mit der neuen IVDR gelten ab dem 26. Mai 2022 strengere Anforderungen an die Leistungsbewertung, insbesondere an die technische Dokumentation und die Vigilanz.

Um den neuen Anforderungen der IVDR zu entsprechen, müssen die Leistungsnachweise für bestehende Produkte möglicherweise in erheblichem Umfang aktualisiert werden. Aus diesem Grund sollten Hersteller eine sogenannte GAP-Analyse, d.h. einen umfassenden, systematischen Ist/Soll-Abgleich, durchführen, um Lücken („gaps“) im Leistungsnachweis für derzeit auf dem Markt befindliche Produkte mit den neuen Regularien zu identifizieren.

Die Biomex GmbH unterstützt Hersteller bei der Planung und Durchführung der erforderlichen GAP-Analyse – sprechen sie uns an!