This template intended for class I devices provides a concise summary of the results and conclusions derived from the analysis of post-market surveillance (PMS) data, as gathered per the post-market surveillance plan. Prepared in strict accordance with Regulation (EU) 2017/745 – Article 83, 84, 85, Section 1.1 of Annex III, ISO/TR 20416:2020, NB-MED-2_12-1_rec1, MDCG 2022-21, MEDDEV 2.12.1 rev. 8, and MDCG 2023-3, this report adheres to regulatory requirements and industry standards. It includes a comprehensive analysis of PMS data, highlighting any trends, patterns, or significant findings related to device performance, safety, and effectiveness. It provides a rationale and description of any preventive or corrective actions taken in response to identified issues or emerging concerns.
This template is designed by highly experienced professionals for all medical device companies. Click below to get a preview of this template.
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