Team-NB issues recommendations on the classification of SARS-CoV-2 IVDs

Team-NB, the European Association of Medical Devices Notified Bodies, has released a position paper providing recommendations for manufacturers of IVDs intended to detect the presence or the exposure to SARS-CoV-2. Taking into consideration MDCG 2020-16’s guidance on classification rules for IVDs under IVDR, Team-NB argues that, while the initial device classification as Class D was appropriate during the pandemic, it is to be argued whether this classification is still valid nowadays as COVID-19 is no longer considered a public health emergency of international concern (PHEIC). Thus, in light of this reassessment, Team-NB provides alternative possible classifications:

  • Classification as Class B device (Annex VIII rule 6 IVDR);
  • Classification as Class C devices (Annex VIII rule 3c IVDR);

The consequences of reclassifying to any of the above classes are also considered in Team-NB’s document. As such, the potential remaining risk for vulnerable populations and available data in the post-pandemic phase play a big role in the classification of the IVDs which would, nevertheless, need to be continually assessed in the future.

You can read this and other Team-NB position paper documents in our IVDR – Position Papers section.


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