This session will review the unexpected uptick of Self-declared Class I devices being presented for technical file remediation. We’ll present case studies that feature some of the challenges we’ve encountered surrounding classification, the appropriate scope of the quality management system, and clinical evaluation of this class of devices.
Learning Objectives:
Understand challenges regarding classification of low-risk devices.
Determine the appropriate quality management system scope for legal manufacturers.
Justify the Class I Self-declared classification to Authorized Representatives and Competent Authorities.