Schedule 2 Ivds

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 2 of the Medical Devices Rules 2017 specifies classification and regulatory requirements for in vitro diagnostic devices (IVDs). Key areas covered include: device categorization by risk level, pre-market approval pathways, quality management system requirements, labelling and packaging standards, and post-market surveillance obligations. IVDs are classified into three categories based on their intended use and risk to public health, with corresponding approval timelines and documentation requirements.