RAYLYTIC image analysis methods appear in first pan-European consensus on clinical evaluation requirements for joint arthroplasty devices
EFORT, the European Federation of National Associations of Orthopedics and Traumatology, recently released its first consensus on “Medical and Scientific Research Requirements for the Clinical Introduction of Artificial Joint Arthroplasty Devices.”
The consensus comes as part of efforts to define and standardize sufficient performance requirements and evaluation methodologies under the new (pre-)clinical data requirements under the EU Medical Device Regulation (EU MDR).