EC Council Directives related to Active Implantable Medical Devices, 10/07

$0.00

This document contains the cumulative directives of the European Parliament and Council from June 1990 through October, 2007 regarding active implantable medical devices.

An active implantable medical device is defined as a device that relies on a source of energy other than that which is generated by the human body or gravity and is intended to be introduced into the human body through medical intervention and remain in the body after the procedure.

• Section I. General Requirements, point 9, requires that medical device software is validated to the state of the art taking into account the principles of development life cycle, risk management, validation, and verification.
• Section I. General Requirements, point 15, requires sufficient instructional documentation to allow the physician to select a suitable device and corresponding software.
• Section I. General Requirements, point 15, also requires sufficient instructional documentation to allow the physician and patient to use the software correctly.