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)

Product Classification

In the IVDR, a new classification system applies to in vitro diagnostics - instead of the earlier lists, the IVDR now defines the four risk classes A, B, C and D in Annex VIII into seven rules. Products from class B or higher will in future require the consideration of a Notified Body, which significantly increases the number of products that must be monitored by a Notified Body.

  • Class A: Includes low risk non-critical products, such as washing solutions, buffers or general culture/nutrient media.
  • Class B: Includes less critical parameters such as glucose or white blood cells. Class B also represents the “default class” for parameters that do not fall under any of the rules mentioned.
  • Class C: Includes products with critical values, such as all genetic tests, almost all companion diagnostics (CDx), tests for determining disease stages or infectious diseases, prenatal tests, and tests for newborn screening. Most self-tests (by patients) also fall into this class.
  • Class D: Includes products with highly critical values, such as those for transfusion medicine or those for determining life-critical and at the same time highly contagious diseases.

The regulation is to be implemented directly in the member states and is intended to lead to a harmonization of standards for in vitro diagnostics within the European Union. As a consequence, the classification of the products determines the way in which the conformity assessment is carried out.

Biomex GmbH supports manufacturers in this first step towards achieving IVDR conformity and with many other questions - contact us!

Klassifizierung der Produkte

In der IVDR gilt für In-vitro-Diagnostika ein neues Klassifizierungssystem - statt der bisherigen Listen, definiert die IVDR im Anhang VIII in sieben Regeln nun die vier Risikoklassen A, B, C und D. Produkte ab Klasse B oder höher erfordern zukünftig die Einbeziehung einer Benannten Stelle, wodurch sich die Zahl an Produkten, die von einer Benannten Stelle überwacht werden müssen deutlich erhöht.

  • Klasse A: Umfasst unkritische Produkte mit geringem Risiko, wie Waschlösungen, Puffer oder allgemeine Nährmedien.
  • Klasse B: Umfasst weniger kritische Parameter, wie Glukose oder Leukozyten. Die Klasse B ist auch die „Default-Klasse“ für Parameter, die unter keine der genannten Regeln fallen.
  • Klasse C: Umfasst Produkte mit kritischen Werten, wie beispielsweise alle Gentests, fast alle therapiebegleitenden Diagnostika (CDx), Tests zum Bestimmen von Krankheitsstadien oder ansteckenden Krankheiten, Pränataltests oder Tests für das Neugeborenenscreening. Auch die meisten Selbsttests (durch Patienten) fallen in diese Klasse.
  • Klasse D: Umfasst Produkte mit höchstkritischen Werten, wie für die Transfusionsmedizin oder zur Bestimmung lebenskritischer und gleichzeitig hochansteckender Krankheiten.

Die Verordnung ist unmittelbar in den Mitgliedsstaaten umzusetzen und soll so innerhalb der Europäischen Union zu einer Vereinheitlichung der Standards für In-vitro-Diagnostika führen. Folglich bestimmt die Klassifizierung der Produkte den Weg der Konformitätsbewertung.

Die Biomex GmbH unterstützt Hersteller in diesem ersten Schritt zur Erlangung der IVDR-Konformität und bei vielen weiteren Fragestellungen – sprechen Sie uns an!