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 relevant to their classification and intended use.