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)

Conformity Assessment Procedure

After the products have been classified, a number of different assessment procedures exist for each product category. In addition to the four risk classes, the IVDR differentiates between other types of in-vitro diagnostics: In addition to products for near patient testing (NPT) and products for personal use (by patients / laymen), the IVDR also mentions companion diagnostics.

The amendment of the guideline has essentially reduced the choice of possible conformity assessment procedures to three options:

For class A products without sterility requirements, the conformity assessment is based exclusively on the technical documentation (TD, Annex II of the IVDR) as well as the TD on post-market-surveillance (Annex III of the IVDR).

All other products can be placed on the market subject to an additional complete quality assurance system plus the assessment of the technical documentation (Annex IX of the IVDR) or a specimen check plus a production quality assurance check (Annexes X and XI of the IVDR). When evaluating the technical documentation, the IVDR distinguishes whether this must be done per product category (class B), per product group (class C) or per product (class D).

The conformity assessment of class D products also requires the involvement of European reference laboratories, whose task it is to verify the performance of the product as well as the compliance with relevant specifications (Common Specifications, CS).

Biomex GmbH has many years of experience with approval of IVDs in accordance with the current guidelines and supports manufacturers both in an advisory capacity when the conformity assessment procedure is defined, and in the form of practical support where clinical studies are required.

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