Team-NB: Notified body approach for multiplex IVDs

Team-NB, the European Association of Medical Devices of Notified Bodies, published a position paper on the approach to the Technical Documentation assessment of multiplex IVD devices.

Multiplex in vitro diagnostic medical devices

Multiplex in vitro diagnostic medical devices are devices with more targets or markers (several allergens or bacteria) simultaneously detected in one common procedure. Usually, they can detect over 100 targets or markers.

Multiplex IVD devices are sold as one device. Therefore, they have one Basic UDI-DI and one intended purpose statement. Nonetheless, the conformity assessment of such devices is challenging because the Notified Body cannot assess the data for each target or marker.

Considerations and examples

The position paper of the Team-NB suggests that the conformity assessment verification should focus on the technology used for the detection of the targets or markers. In addition, the Notified Body should take a risk-based approach to decide which marker specific data they should review. On this basis, the device could be classified into multiple classes with the priority given to the highest class. On the sampling, Team-NB states that for Class C and Class B markers or target the Notified Body can follow this approach. For the highest risk, the Notified Body would review the technical documentation for all class D markers. Eventually, Team-NB concludes by advising to record the approach used and rationale in the conformity assessment documentation.

Specifically, the document includes some examples of what the Technical Documentation assessment of multiplex IVDs should include:

• Mass spectrometer Microbial Identification System claiming the identification of over 200 bacteria: the assessment should focus on the design, verification, and validation of the reading system. Moreover, with a risk-based approach, the Notified Body review data on a sampling basis.
• Immuno Solid-phase Allergen Chip (ISAC) technology for specific IgE test against > 100 allergens: the assessment should focus on the design, verification, and validation of the reading system. In this case, the Notified Body should justify which approach led them to review certain data, as the risk class is likely the same for all species in the panel.
  

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