IMDRF new Consultations Focus on IVD Classifications, Regulatory Assessors

The International Medical Device Regulators Forum  released two consultations for comment on classifying in vitro diagnostics (IVDs) and improving the efficiency and ensuring regulators appropriately conduct assessments of Conformity Assessment Bodies 

Principles of In Vitro Diagnostic (IVD) Medical Devices Classification

Competence and Training Requirements for Regulatory Authority Assessors of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews