BackgroundThe Medical Device Coordination Group (MDCG) has issued an update to the European vigilance guidance MDCG 2023-3. The document now covers devices regulated under the IVDR. As Emergo by UL reported last year, the initial version of MDCG 2023-3 explicitly excluded IVDs from its scope. Guidance on vigilance reporting for IVDsThe guidance now includes IVD-specific examples of incidents, se..
