About this document
MDR Chapter II Classification by gangadhar kedar is a document available to read on EtoBox.
Chapter II of the Medical Devices Rules, 2017 outlines the classification of medical devices based on risk factors, with categories ranging from Class A (low risk) to Class D (high risk). It establishes standards for compliance, emphasizing the importance of safety and performance principles, including the necessity for clear labeling and risk management. Additionally, it mandates clinical evaluations to ensure the safety and effectiveness of medical devices.
- Author
- gangadhar kedar
- Language
- EN