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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Nach erfolgter Klassifizierung der Produkte, ergeben sich für jede Produktkategorie verschiedene Bewertungsverfahren. Zusätzlich zu den vier Risikoklassen unterscheidet die IVDR noch weitere Typen von In-vitro-Diagnostika: Neben Produkten für patientennahe Tests (Near Patient testing, NPT) und Produkte zur Eigenanwendung (durch Patienten / Laien) nennt die IVDR noch therapiebegleitende Diagnostika.

Die Auswahl möglicher Konformitätsbewertungsverfahren hat sich durch die Novellierung der Richtlinie im Wesentlichen auf drei Optionen reduziert:

Für Klasse A Produkte ohne Anforderungen an die Sterilität, basiert die Konformitätsbewertung ausschließlich auf der Technischen Dokumentation (TD, Anhang II IVDR) und der TD über die Überwachung nach dem Inverkehrbringen (Anhang III IVDR).

Alle anderen Produkte können im Rahmen eines zusätzlichen vollständigen Qualitätssicherungssystems plus der Bewertung der Technischen Dokumentation (Anhang IX IVDR) oder einer Baumusterprüfung plus einer Produktionsqualitätssicherung (Anhänge X und XI IVDR) in Verkehr gebracht werden. Die IVDR differenziert bei der Bewertung der technischen Dokumentation, ob diese pro Produktkategorie (Klasse B), pro Produktgruppe (Klasse C) oder pro Produkt (Klasse D) erfolgen muss.

Die Konformitätsbewertung von Produkten der Klasse D erfordert weiterhin die Einbindung von europäischen Referenzlaboren, deren Aufgabe es ist, die Leistung des Produkts und die Einhaltung relevanter Vorgaben (Common Specifications, CS) zu verifizieren.

Die Biomex GmbH verfügt über jahrelange Erfahrung im Bereich der Zulassung von IvDs gemäß den aktuellen Richtlinien und unterstützt Hersteller sowohl beratend bei der Definition des Konformitätsbewertungsverfahrens als auch praktisch bei der Begleitung notwendiger klinischer Studien. Sprechen sie uns an!