SOFTWARE MD/IVD NEWS

Multiplex #IVD devices | Assessment Common Approach


August 23, 2022

Multiplex in vitro diagnostic (IVD) devices concurrently detect two or more targets/markers. Multiplex IVDs are sold as one device with their sole intended purpose.

They may be intended to detect dozens of targets/markers, such as allergies or microorganisms. Due to the possibly high number of targets/markers in the intended purpose, assessing the Technical Documentation and #clinicaldata to support the detection of each target/marker is problematic.

Due to the potentially large number of targets/markers, a risk-based sampling approach should be considered. In these cases, the notified body review should focus on the multiplex IVD device’s detection technology.

Choosing which marker data to review, using a risk-based approach. Based on targets/markers there may be different classifications; the #IVDR highest-class markers should be reviewed first. Multiple deficiencies during the initial review may cause the notified body to sample additional analytes or update the sampling plan during the certification cycle.

  • Class C and B markers/targets can be sampled using the risk-based approach.
  • All class D marker documentation will be reviewed.

The Notified Body Conformity assessment documentation should include the approach and rationale used to assess the Technical Documentation.


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MED IVD HEALTHTECH S.L ha sido beneficiaria de la subvención de contratos de trabajo de la Comunidad de Madrid, cofinanciado por el Fondo Social Europeo dentro de la Ayuda a la Recuperación para la Cohesión y los Territorios de Europa (REACT-UE), a través del Programa Operativo Regional FSE, en el marco del Programa Impulso a la Contratación Estable de Jóvenes para la Recuperación Económica, gestionado por la Dirección General del Servicio Público de empleo de la Consejería de Economía, hacienda y empleo de la Comunidad de Madrid.


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