Schedule 4 Essential Principles

This page provides an overview of this Schedule of the Medical Devices Rules 2017 and links to the official text.

Official source: MDR 2017 — CDSCO

Schedule 4 of the Medical Devices Rules 2017 establishes the Essential Principles that medical devices must meet to ensure safety and performance. These principles cover: safety and performance requirements, design and manufacturing standards, risk management, clinical evidence requirements, labelling and traceability, post-market surveillance, and adverse event reporting. Devices must demonstrate compliance with applicable Essential Principles through technical documentation, risk management files, quality management systems, and clinical evidence. The breadth of Essential Principles applied depends on device classification and complexity; higher-risk devices require evidence for a broader range of principles.