The Law Today

Public Health Institute approves Guidelines for Clinical Evaluation of Medical Devices.

03 May 2021


On April 6, 2021, it is published in the Official Gazette the extract of the Exempt Resolution N°499, dated March 25, 2021, which approves the Guide for Clinical Evaluation of Medical Devices, of the Department of the National Agency of Medical Devices, Innovation and Development of the Institute of Public Health (ISP).

This Guide provides technical guidance to manufacturers to perform the clinical evaluation of a medical device (with the exception of in vitro diagnostic medical devices), regulating, among other things, the moments in which the clinical evaluation must be performed and the duties of the manufacturer to inform the frequency with which its medical device must be updated in its clinical evaluation.

Likewise, the Guide establishes several stages for carrying out this clinical evaluation, which are divided into five, namely, definition of the scope and planning of the clinical evaluation; identification of the data; evaluation of the data; analysis of the clinical data; and, the clinical evaluation report.

Finally, it establishes different annexes, within which are regulated (a) clinical evaluations applicable to medical devices intended for unmet medical needs; (b) analysis of clinical data, in consideration of safety principles, conformity assessment, performance principles and principles of acceptability of undesirable side effects; (c) a checklist for the release of the clinical evaluation report; (d) a declaration of interests of the evaluators; and, (e) the post-marketing clinical follow-up that must be made.


Should you require additional information on this matter, please contact Andrea Abascal ( and/or Rocío Vergara (