GMED Newsletter - N°20 - Post-Market Surveillance of Devices - Methods and Types of PMS Data

Sep 22, 2026

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GMED Newsletter N°20 I March 2025 explains post-market surveillance (PMS) as an essential process to ensure the safety and effectiveness of medical devices on the market. It links PMS to the manufacturer quality management system and references MDR (EU) 2017/745 and IVDR (EU) 2017/746, describing strengthened obligations and oversight by competent authorities and notified bodies. The newsletter details PMS data methods (proactive and reactive), reporting and PSUR activities, vigilance requirements, and the impact of incident information on certification decisions.

LanguageEnglish

CategoryPresentations

FormatPDF

Pages4

Reading Time2 min

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Methods and Types of PMS Data

Increased Vigilance under MDR and IVDR

PSUR and PMS Reports

Guides and support documents

N°20 I M A R C H 2 0 2 5 Newsletter Version Française POST-MARKET SURVEILLANCE OF DEVICES The Post-Market Surveillance (PMS) system is an essential process for ensuring the safety and effectiveness of medical devices placed on the market. Integrated into the manufacturer's quality management system, PMS is based on Articles 10.10 of Regulation (EU) 2017/745 (MDR) and 10.9 of Regulation (EU) 2017/746 (IVDR). This process has been significantly strengthened since the MDR and IVDR came into force, introducing more regulations and requirements for manufacturers and increased oversight by competent authorities and Notified Bodies (NBs). A METHODS AND TYPES OF PMS DATA The post-marketing surveillance system is based on the following elements: THIS NEWSLETTER IS FOR INFORMATION ONLY AND DOESN’T CONSTITUTE A NORMATIVE OR REGULATORY EVIDENCE. Newsletter N°20 I M A R C H 2 0 2 5 This process is implemented as follows: • Establishment of surveillance plans: the manufacturer defines a PMS plan incorporating a PMCF1/PMPF􀀞 plan, in which he describes and documents the strategy for collecting, recording, and analyzing PMS data. • Establishment of reporting: depending on the risk class of the device, the manufacturer draws up a PMS report or a Periodic Safety Update Report (or PSUR, detailed below), including, where applicable, a PMCF/PMPF report, in which it summarizes the results obtained by following the strategy defined in the Surveillance plan. The PMS system collects two types of data: • “Proactive”data:the resultsofallactivitiesdefinedand implemented by the manufacturer to collect information on his device; • “Reactive” data: data that are available and extracted from the flow of information going passively back to the manufacturer. The methodology and data analysis tools set out in the device’s post-market surveillance plan enable the manufacturer to carryout an analysis of the data collected. The manufacturer is then able to detect statistical signals and trends in relation to PMS data. That information is then used to improve the product, restore compliance, and/or communicate with the competent authorities. | EXAMPLES OF PMS DATA TYPES | | | --- | --- | | PROACTIVE DATA | REACTIVE DATA | | • User feedback (customer surveys, expert opinions);
• Data from literature;
• PMCF/PMPF data (registers, studies). | • Audit/inspection data;
• Quality management system data (NC, CAPA/FSCA, risk management);
• Data from complaints/incidents (including vigilance). | B INCREASED VIGILANCE UNDER MDR AND IVDR Vigilance under the regulations sets new requirements for all players, especially NBs. Vigilance reports must be communicated to the competent authorities, as well as to NBs. This communication to NBs, introduced by the regulations, makes it possible to verify the impact of incidents on the validity of certificates issued, even under one of the directives. These vigilance reports include the following: • Manufacturer Incident Report (MIR); • Periodic Safety Report (PSR); • Trend Report (TR); • Field Safety Corrective Action (FSCA); • Field Safety Notice (FSN). Access to notifications of vigilance cases for devices placed on the market enables the NB to make the link with the information collected by other surveillance means (audits and assessments) and to activate, if necessary, additional surveillance measures such as additional or unannounced audits or a documentary review. In the most critical cases, the validity of the certificate may be called into question. The NB is empowered to restrict, suspend, or withdraw the certificate concerned. The addition of the notified body as a recipient of vigilance reports helps to limit the risk to the patient and the user, thanks to the control and monitoring actions taken on the manufacturer by the NB. C PSURAND PMS REPORTS The manufacturer draws up reports summarizing all the data collection activity and the concl

FAQs

What is the purpose of the post-market surveillance (PMS) system?

PMS ensures the safety and effectiveness of medical devices placed on the market. It supports analysis of collected data to improve products, restore compliance, and inform competent authorities.

How does the newsletter distinguish proactive vs reactive PMS data?

Proactive data comes from activities defined and implemented by the manufacturer to collect device information. Reactive data comes from information that passively returns to the manufacturer, including complaints/incidents and audit-related sources.

What kinds of vigilance reports are mentioned under MDR and IVDR?

The newsletter lists Manufacturer Incident Report (MIR), Periodic Safety Report (PSR), Trend Report (TR), Field Safety Corrective Action (FSCA), and Field Safety Notice (FSN). It also explains how notified bodies can use these to trigger additional surveillance measures.

Sep 22, 2026

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