How to prepare a beneficial and efficient PMS Report

English

Post-market surveillance (PMS) is both a legal and operational requirement under the European Union’s medical device and in vitro diagnostic Regulations. It enables manufacturers to monitor the safety and performance of their products continuously once they are in use by patients and end users. In this article, Dilsat Pinar Pergjetani presents a practical, step-by-step guide to developing PMS Reports that not only meet regulatory expectations but also deliver real business value. The article outlines how to establish a structured PMS Plan, gather meaningful data from a range of sources, analyse findings to identify trends and risks, and translate those results into clear, actionable conclusions. It highlights the critical link between routine complaints and field incidents (referred to as vigilance data) and the broader PMS Report, explaining how these information streams can be aligned to present a coherent picture of a device’s benefit-risk profile. The importance of integrating PMS activities with risk management, clinical evaluation, and the organisation’s Quality Management System is illustrated through practical examples. In addition, the article identifies common regulatory gaps, warns against frequent pitfalls, and offers guidance on producing high-quality PMS Reports.

Specification: 18 pages plus covers, in English, supplied by email as a PDF.

This article has been published in the February 2026 issue of the Journal of Medical Device Regulation.