Chapter Ii Classification

This page summarises the key rules in this chapter of the Medical Devices Rules 2017 and links to the relevant primary source.

Official source: MDR 2017 — CDSCO

Chapter II establishes the classification of medical devices into three classes (Class A, Class B, and Class C) based on risk and regulatory controls required. Class A devices present minimal risk, Class B devices present moderate risk, and Class C devices present high risk. The chapter references the Schedule to the rules which lists specific devices and their classifications.