Team-NB members adopted during the General Assembly meeting, at the unanimity of the IVD NBs presents, a guidance on the interpretation used by notified bodies to identify changes affecting the performance, suitability, or intended use of a companion diagnostic device that necessitate consultation with medicinal product authorities. Team-NB-PositionPaper-IVDR-Significant-changes-V2 L’article TEAM NB Position Paper on IVDR Changes to companion diagnostic devices est apparu en premier sur tea...
