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Part 1 covers essential requirements such as appointing a person responsible for regulatory compliance, ensuring financial coverage, implementing a Quality Management System (QMS), and establishing a regulatory intelligence system. Additionally, it discusses the importance of archiving, confidentiality, and cooperation with authorities and notified bodies.
Part 2 covers the requirements before placing a medical device on the market. It includes product classification, risk management, clinical evaluation, and ensuring compliance with safety standards. Additionally, it outlines the need for technical documentation, UDI assignment, and conformity assessment procedures for CE marking.
Part 3 focuses on post-market requirements for medical devices. It includes post-market surveillance (PMS), reporting incidents, trend analysis, and maintaining traceability of devices. The guide also emphasizes the importance of ongoing compliance, updating technical documentation, and cooperation with authorities for device safety and effectiveness.