The new version of the Team-NB Code of Conduct establishes principles of transparency, coherence and quality in the work of Notified Bodies operating under the MDR and IVDR regulations. The document presents clear criteria for audits, technical review, management of conflicts of interest, use of external experts and deadlines for responding to non-conformities.

With the entry into force of the IVDR, rapid antigen tests for COVID-19 are now classified as Class D devices, requiring assessment by a Notified Body.