Note 2 : Provision of the medical device for purposes of clinical evaluations and/or evaluation of performance is not considered to be delivery. 7.3.7 Control of design and development changes: Design and development changes shall be identified and records, maintained. The changes shall be reviewed, verified and validated, as; appropriate, and approved before implementation. The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered. Records of the results of the review of changes and any necessary actions shall be; maintained. Note: Each manufacturer shall establish and maintain a Design History File for each type of device. The Design History File shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of design and development.