New studies specifically planned or conducted to examine a safety issue should be described in the PSURs. (v) A PSUR should be structured as follows:— (a) Title Page: The title page of PSUR shall capture the name of the Medical device; reporting interval; approved indication of Medical devices; date of approval of the medical device; date of marketing of medical device; licence name and address. (b) Introduction: This section of PSUR shall capture the reporting interval; medical device's intended use, mode of action or principle of operation, risk class and a brief description of the approved indication and population. (c) Current worldwide marketing authorization status: This section of PSUR shall capture the brief narrative overview including details of countries where the device is currently approved along with date of first approval, date of marketing and if the product was withdrawn in any of the countries with reasons thereof.