Principles of Conformity Assessment for Medical Devices

• Date: October 05, 2009
• Source: www.ghtf.org

This document describes:

• the evidence and procedures that may be used by the manufacturer to demonstrate that a medical device is safe and performs as intended by the manufacturer and conforms to the Essential Principles of Safety and Performance for Medical Devices;
• the conformity assessment elements that should apply to each class of device such that the regulatory demands increase with the risk class of the medical device;
• the process by which a RA, or CAB appointed by or acting on behalf of the RA, may confirm that such elements are properly applied by the manufacturer; and
• the manufacturer’s written attestation that it has correctly applied the conformity assessment elements relevant to the classification of the device, i.e. the ‘Declaration of Conformity’.

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