New European union regulations related to whole slide image scanners and image analysis software

• Main Authors: Marcial Garcia-Rojo (Author), David De Mena (Author), Pedro Muriel-Cueto (Author), Lidia Atienza-Cuevas (Author), Manuel Dominguez-Gomez (Author), Gloria Bueno (Author)
• Format: Book
• Published: Elsevier, 2019-01-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Whole slide imaging (WSI) scanners and automatic image analysis algorithms, in order to be used for clinical applications, including primary diagnosis in pathology, are subject to specific regulatory frameworks in each country. Until May 25, 2018, in the European Union (EU), in vitro diagnostic (IVD...