EU MDR & EU IVDR Compliance Strategy for Medical Devices and Diagnostics

This program provides a comprehensive understanding of the European Union’s regulatory frameworks governing medical devices and in-vitro diagnostic devices. Participants will explore the requirements of the Medical Device Regulation (EU MDR 2017/745) and In-Vitro Diagnostic Regulation (EU IVDR 2017/746), focusing on regulatory pathways, conformity assessment procedures, clinical evidence requirements, and post-market surveillance obligations. The course equips regulatory professionals with practical insights to navigate compliance challenges and successfully maintain market access within the EU.