MDR Readiness Checklist for Compliance Assessment

This document is a checklist designed to assist organizations in evaluating their quality management systems and technical documentation against the requirements of the Medical Device Regulation (MDR). It outlines the necessary steps to determine compliance and identifies areas needing attention before the initial MDR conformity assessment. The checklist emphasizes that it cannot serve as evidence for transition audits, as compliance must be confirmed by auditors during the assessment. It details various aspects of MDR compliance, including scope, classification, transitional provisions, general requirements, technical documentation, post-market procedures, EUDAMED registration, and clinical evaluation. Each section prompts users to assess their readiness and identify tasks that remain to be completed. The document serves as a practical tool for organizations preparing for MDR compliance and aims to ensure all necessary regulatory obligations are met.