---
title: "MDCG on Post-Market Surveillance (PMS) Released"
description: "On 19 December 2025, MDCG published MDCG 2025-10, clarifying post-market surveillance (PMS) requirements for medical devices and IVDs under MDR and IVDR — emphasising a proactive, lifecycle-wide, QMS-integrated approach."
url: https://qbdgroup.com/zh-cn/regulatory-updates/mdcg-2025-10-post-market-surveillance-pms-released
type: "Regulatory update"
language: zh-cn
published: 2025-12-19
author: "Kirsten Van Garsse, Business Unit Manager RA IVD & Representative Services"
category: "Regulatory Affairs"
publisher: "QbD Group"
citation: "QbD Group, \"MDCG on Post-Market Surveillance (PMS) Released\", https://qbdgroup.com/zh-cn/regulatory-updates/mdcg-2025-10-post-market-surveillance-pms-released"
---
# MDCG on Post-Market Surveillance (PMS) Released
> On 19 December 2025, MDCG published MDCG 2025-10, clarifying post-market surveillance (PMS) requirements for medical devices and IVDs under MDR and IVDR — emphasising a proactive, lifecycle-wide, QMS-integrated approach.

On 19 December 2025, the Medical Device Coordination Group (MDCG) published [**MDCG 2025-10 – Guidance on post-market surveillance (PMS) of medical devices and in vitro diagnostic medical devices**](https://health.ec.europa.eu/document/download/a9ad86b7-1b8e-4bae-beb4-48b2b3ed2f05_en?filename=mdcg_2025-10_en.pdf), providing comprehensive clarification on PMS requirements under Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR).

The guidance reinforces PMS as a **proactive, continuous, and lifecycle-wide process**, integrated within the manufacturer's Quality Management System (QMS), ensuring devices remain safe, performant, and compliant once placed on the market.

The document outlines **the structure and expectations** of a PMS system and PMS plan, emphasising the need for manufacturers to systematically collect and analyse real-world data, including complaints, incidents, literature, and user feedback. It highlights the importance of proactive data collection, requiring manufacturers to actively seek information rather than relying solely on passive reporting, and to define appropriate methods, indicators, and thresholds for ongoing benefit-risk evaluation.

MDCG 2025-10 also details the **PMS lifecycle activities**, from identifying data sources and collecting relevant data to analysing outcomes and determining necessary corrective or preventive actions. The guidance stresses that PMS outputs must be used to update key documentation and processes, including risk management, clinical/performance evaluation, technical documentation, and labelling, ensuring continuous alignment with the state of the art.

Furthermore, the guidance **clarifies the interaction of PMS with other QMS processes**, requiring that PMS data feeds into benefit-risk determination, design and manufacturing improvements, vigilance activities, and trend reporting obligations. It also reinforces expectations for PMS reporting, including PMS reports and Periodic Safety Update Reports (PSURs) depending on device classification.

## What does this mean for you?

For manufacturers, MDCG 2025-10 reinforces **the need for a robust, proactive, and well-documented PMS system embedded in the QMS**, with clear planning, systematic data collection, and defined methodologies for analysis. It highlights increased expectations on using post-market data to continuously update risk management, clinical/performance evidence, and device design, while ensuring timely corrective actions and regulatory reporting throughout the device lifecycle.
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Source: https://qbdgroup.com/zh-cn/regulatory-updates/mdcg-2025-10-post-market-surveillance-pms-released — © QbD Group. Quote freely with attribution and a link back.