MDR Readiness Checklist for EU Compliance

This document is a checklist designed to assist organizations in confirming their readiness for the Medical Device Regulation (MDR) transition from 2025 to 2028. It outlines various aspects of compliance, including portfolio-level readiness, device-level eligibility, packaging validation, sterilization validation, distribution, labeling, risk management, and technical documentation. Each section specifies critical requirements such as the approval of MDR transition plans, the assignment of cross-functional teams, and the necessity of updated standard operating procedures (SOPs). The checklist also emphasizes the importance of maintaining valid certificates, conducting risk evaluations, and ensuring proper training records. Additionally, it addresses the need for thorough documentation and evidence linking to compliance standards. By following this checklist, organizations can systematically evaluate their preparedness for the MDR and ensure they meet all necessary regulatory requirements.