Team-NB publishes position paper on conformity assessment following down-classification of SARS-CoV-2 IVDs
This regulatory update summarises the Team-NB Position Paper adopted on 12 December 2025, which describes how IVD Notified Bodies will handle conformity assessments following the down-classification of SARS-CoV-2 in vitro diagnostic devices under Regulation (EU) 2017/746 (IVDR). The document reflects the IVD Expert Panel scientific advice published in January 2025 and the subsequent update of MDCG 2020-16 Revision 4, detailing classification changes, certification scenarios, and manufacturer obligations related to SARS-CoV-2 tests.
New MDCG 2024-8 Rev. 1 Document: Key Updates for Conformity Assessment under the IVDR
MDCG 2024-8 Revision 1 brings crucial updates for IVDR compliance, including streamlined processes for conformity assessment and updated guidelines for notified bodies. Stay informed about regulatory changes in in vitro diagnostic devices under Regulation (EU) 2017/746. Learn how Smart MDR can support your business with expert guidance on IVDR conformity, ensuring compliance with EU medical device regulations. From quality management systems to technical documentation, we help you navigate the complexities of regulatory frameworks with confidence.