MDCG 2025-10 Post Market Surveillance for Medical Devices & IVDs - Sushvin Consultancy

The Medical Device Coordination Group (MDCG) has issued guidance titled MDCG 2025-10, which outlines how manufacturers should monitor medical devices and in vitro diagnostic devices (IVDs) after they are placed on the market. Released in December 2025, the guidance provides a structured framework to help ensure that products remain safe and effective throughout their lifecycle.

Though not legally mandatory, this guidance clarifies what’s expected under EU regulations for medical devices (MDR 2017/745) and IVDs (IVDR 2017/746). It stresses that post market surveillance (PMS) is an ongoing, active process that should be part of a manufacturer’s Quality Management System (QMS).

MDCG 2025 10 emphasizes that PMS is central to a device’s lifecycle. By embedding proactive surveillance into the QMS, manufacturers can ensure ongoing safety and effectiveness.

For regulatory professionals, this guidance is a reminder that compliance is always evolving. PMS is both a requirement and an opportunity to strengthen safety, support innovation, and build trust.

Important of PMS

Medical devices and IVDs may perform differently once they are used in real-world clinical settings. PMS enables manufacturers to:

  • Collect data from multiple sources after the product is placed on the market.
  • Update technical documentation to reflect real-world performance.
  • Identify emerging risks early and implement necessary changes.
  • Maintain transparent communication with regulators, notified bodies, and users.

Scope of the Guidance

MDCG 2025-10 applies to all medical devices and IVDs. The guidance aims to:

  • Describe the PMS system required under MDR and IVDR.
  • Outline the PMS plan as part of technical documentation.
  • Detail the key activities involved in PMS.
  • Explain how PMS links with other QMS processes such as risk management and clinical evaluation.

The PMS System – General Obligations

Under Article 83 of the MDR and Article 78 of the IVDR, manufacturers are required to establish, implement, and maintain a PMS system that is proportionate to the risk class of the device. Key obligations include:

  • Actively collecting data related to quality, performance, and safety.
  • Analyzing collected data to determine whether corrective or preventive actions are required.
  • Integrating PMS outputs with other QMS processes.
  • Reporting PMS effectiveness to top management.

For custom-made devices (CMDs), the same PMS requirements apply. Manufacturers must document post-market experience and report serious incidents in accordance with regulatory requirements.

The PMS Plan

The PMS plan, as required under Annex III of the MDR and IVDR, defines how post-market surveillance activities are conducted. It should include:

  • The scope of devices covered by the PMS system.
  • Monitoring frequency and methods based on device risk.
  • Proactive data collection activities beyond complaint handling.
  • Methods for assessment and analysis of data.
  • Indicators for reassessing risks and benefit-risk balance.
  • Procedures for investigating complaints and incidents.
  • Communication processes with competent authorities and users.
  • Corrective and preventive action procedures.
  • Tools to trace and identify affected devices.
  • Plans for post-market clinical or performance follow-up.

The guidance highlights the importance of a proactive approach, encouraging manufacturers to actively gather information through surveys, literature reviews, studies, and user feedback.

Main Activities of Post-Market Surveillance

MDCG 2025-10 describes PMS as a continuous cycle of activities:

  • Determining Information Sources: Identifying relevant data sources, while exercising caution when using less reliable sources such as social media.
  • Collecting Data: Establishing structured processes to consistently gather post-market information.
  • Assessment and Analysis: Evaluating data using appropriate analytical methods, with more rigorous analysis required for higher-risk devices.
  • Taking Action: Using PMS outputs to update risk management, clinical or performance evaluation, and technical documentation. Actions may include product changes or process improvements.

This cycle continues throughout the entire lifecycle of the device.

PMS and the Quality Management System

Post-market surveillance is not an isolated process. It is closely linked with other elements of the Quality Management System, including:

  • Risk Management: PMS data supports hazard identification and ongoing risk assessment.
  • Clinical Evaluation: Real-world evidence feeds into clinical and performance evaluations.
  • Technical Documentation: PMS ensures documentation remains accurate and up to date.
  • Management Review: PMS effectiveness is reviewed by management to drive continuous improvement.

This interconnected approach strengthens compliance, enhances safety, and supports continual improvement across the organization.

Summary of the elements to be covered in the PMS plan per section 1(b) of Annex III MDR/IVDR

Required per section 1(b) of Annex III MDR/IVDR Explanation Content in the PMS plan
A proactive and systematic approach to gather information as mentioned in point (a). This approach should enable an accurate characterization of the devices' performance and facilitate comparison with similar products available on the market Manufacturers are required to gather the information mentioned in section 1(a) of Annex III MDR/IVDR. This information is used to enhance understanding of device usage, safety, performance, and usability, and to identify areas for improvement. By collecting data on similar products, manufacturers can compare their device with others on the market. This information is used to demonstrate that the device remains state of the art (SOTA)
  • A compilation of activities with references to procedures for gathering information as mentioned in section 1(a) of Annex III MDR/IVDR.
  • Data sources for comparable products
  • The frequency of each activity and the responsible role(s) or function(s),
Effective and appropriate methods and processes for assessing the collected Data Assessment methods and processes should match the type of device being used. The chosen methods depend on the type and quality of the raw data collected. Devices with higher risk are expected to require more specific data analysis methods. Approaches and Processes
  • Methods for Analysis: Utilize methods such as qualitative or quantitative techniques, as well as statistical approaches, to evaluate the collected data, with an explanation for each choice.
  • Parameters for Analysis: Examples include side effects or incident types, device malfunctions, hazards, harm, complaint rates, and severity.
  • Measurable Values: Examples include batch size, batch quantity, usage hours/frequency, number of devices in use or sold, and number of exposures.
Continuous reassessment of the benefit-risk analysis and risk management, as mentioned in section 3 of Annex I MDR/IVDR, should utilize appropriate indicators and threshold values. Appropriate indicators and threshold values (limits that necessitate action when exceeded) must be determined during the pre-market phase. Data collected from PMS activities is integrated into the risk management process to reassess these indicators and threshold values. Indicators and thresholds relevant for evaluating the impact of hazards, their frequency, and associated risk estimates, as well as the overall risk, benefit-risk ratio, and risk acceptability.
Investigate complaints carefully, use simple tools to track and analyze them, and feed the results back into your safety system. Methods and tools should match the device type: The more critical or higher-risk devices need thorough investigation and analysis of complaints and other market-related experiences. Approaches and Processes for Data Analysis
  • Methods to be used, such as qualitative, quantitative, or statistical methods.
  • Processes for analyzing the collected data, with explanations for their use.
  • For instance, methods outlined in IMDRF Adverse Event Terminology Annex B16, Cause Investigation - Type of Investigation.
Protocols and methods for managing incidents related to the trend report as outlined in Article 88 of the MDR/Article 83 of the IVDR. This includes the procedures to determine any statistically significant rise in the frequency or severity of incidents, along with the observation period. Non-serious incidents or clearly documented expected side-effects might be reported for trends. The method for identifying any significant rise in frequency or severity of these incidents, along with the observation period, should be outlined in the PMS plan or referred to in related procedures that specify these details.
  • References to applicable procedures and statistical methods, including monitored parameters, threshold values, and indicators.
  • Procedures, documentation, and criteria for report submission.
  • Details on the frequency of the activity and the responsible roles or functions, if not specified elsewhere.
Methods and protocols for effective communication with competent authorities, notified bodies, economic operators, and users. Manufacturers need to create processes to ensure effective communication with competent authorities, notified bodies, other economic operators, and users regarding the results of PMS activities.
  • References to necessary procedures, such as contacting and notifying competent authorities, notified bodies, other economic operators, and users, including patients and customers.
  • Details or references to forms, communication methods, and data transfer tools that may be used, along with the responsible roles or functions, if not specified elsewhere.
Reference to procedures for fulfilling the manufacturer's obligations as outlined in MDR Articles 83, 84, and 86 or IVDR Articles 78, 79, and 81. Procedures must be established to facilitate the implementation of the PMS system and the creation of related plans and reports.
  • Include references to procedures for creating or updating PMS plans and reports.
  • Specify the frequency of the activity and the responsible roles or functions, unless detailed elsewhere.
  • Mention related procedures for PMS plans and reports.
  • Provide information on how often the activity takes place and the responsible parties, if not specified in other sections.
Systematic procedures to identify and initiate appropriate measures including corrective actions Procedures should outline the criteria for corrective actions and specify the measures to be taken, such as documenting a nonconformance or initiating a CAPA or FSCA, based on the impact or risk associated with the identified issue. List of criteria that trigger the start of suitable measures or corrective actions. Details of the roles or functions within the organization responsible for specific tasks in an action plan
Tools that effectively trace and identify devices for corrective actions might be necessary. Tools used to identify and trace devices for which corrective actions might be necessary must be described. Procedures describing controls for non-conforming devices (e.g., recall and quarantine) and identification of relevant economic operators are expected to be referenced.
Tools for identifying and tracking devices that may require corrective actions must be described. Procedures for managing non-conforming devices such as recalls need identification of relevant economic operators and must be referenced.
  • A list of methods and tools to trace and identify devices needing corrective action.
  • References to procedures for identifying and tracing devices with specific tools.
  • Details of roles/functions responsible for tasks within a corrective action plan.
A PMCF plan as mentioned in Part B of Annex XIV, or a rationale explaining why a PMCF is not applicable (MDR). The PMCF/PMPF plan is an essential component of the PMS plan. If the manufacturer decides that no specific PMCF/PMPF activities are necessary, a justification must be provided. Planned PMCF/PMPF Activities and Justification
  • Reference the detailed PMCF/PMPF plan or protocol, as needed.
  • Include references to relevant procedures.
  • Provide details on the frequency of activities and the roles or functions responsible, if not specified elsewhere.
  • Justify why PMCF/PMPF is not applicable, if appropriate.

Similarities Between EU (MDCG 2025-10) and UK (MHRA PMS)

1. Proactive Post-Market Surveillance Systems

EU: MDCG 2025-10 emphasizes that post-market surveillance must be proactive rather than reactive. Manufacturers are expected to actively collect data from sources such as registries, scientific literature, surveys, and post-market studies.

UK: The MHRA 2024/2025 PMS regulations similarly require proactive surveillance. Manufacturers must plan systematic data collection and perform trend analysis to monitor device performance and safety.

2. Integration with the Quality Management System (QMS)

EU: PMS is considered a core element of the QMS and is closely linked to risk management, clinical or performance evaluation, and updates to technical documentation.

UK: PMS requirements are embedded in the UK Medical Devices Regulations 2002 (as amended in 2024), ensuring PMS outputs feed into vigilance activities, risk management, and corrective and preventive actions.

3. Risk-Based Approach

EU: PMS obligations are proportionate to the device risk class (Class I–III for medical devices and Class A–D for IVDs). Higher-risk devices require more detailed data collection and in-depth analysis.

UK: MHRA guidance also follows a proportional, risk-based approach, with stricter PMS requirements for higher-risk devices such as implantable medical devices and IVDs.

4. Reporting of Serious Incidents

EU: Manufacturers must report serious incidents and field safety corrective actions to competent authorities within defined timelines, typically 10 days for serious public health threats and up to 30 days for other incidents.

UK: The MHRA requires vigilance reporting of adverse incidents with comparable obligations. Anticipated serious deterioration in health must now be reported within 15 days, reduced from the previous 30-day timeframe.

5. Trend Analysis

EU: MDCG 2025-10 requires the use of appropriate statistical methods to identify significant increases in the frequency or severity of incidents.

UK: The 2024 PMS amendment regulations similarly emphasize trend reporting and analysis to detect early warning signals and emerging risks.

6. PMS Outputs: Reports and PSURs

EU: Manufacturers must prepare PMS Reports for lower-risk devices and Periodic Safety Update Reports (PSURs) for higher-risk devices.

UK: The MHRA requires equivalent PMS documentation, ensuring that manufacturers submit regular surveillance reports and updates to demonstrate ongoing compliance.

Differences: EU (MDCG 2025‑10) vs UK (MHRA PMS Regulation)

Aspect EU (MDCG 2025-10) UK (MHRA PMS Regulation)
Legal Status Non-binding guidance interpreting MDR and IVDR requirements Legally binding regulation with enforceable obligations
Scope Focuses on continuous and proactive PMS integrated into the QMS Defines specific data collection, reporting, and timeline requirements
Reporting Requirements PMS plans, reports, and PSURs mainly for regulators and notified bodies Mandatory PMS summary reports submitted to MHRA
Incident Reporting Timelines Serious incidents reported within 2 to 15 days depending on severity Serious incidents within 10 days, life-threatening risks within 2 days
Regulatory Approach Lifecycle monitoring with flexibility for manufacturers Strict accountability, fixed formats, and defined deadlines

Implications for Manufacturers

MDCG 2025-10 translates into several practical actions for manufacturers:

  • Integrate PMS considerations early in the product development lifecycle.
  • Allocate dedicated resources for post-market surveillance activities.
  • Maintain comprehensive and well-documented PMS records.
  • Engage relevant stakeholders through clear and consistent communication.
  • Apply PMS activities to groups of custom-made devices, not only individual units.

Challenges

Implementing an effective PMS system can be resource-intensive, particularly for small and medium-sized enterprises. Common challenges include:

  • Managing and integrating data from multiple sources.
  • Ensuring appropriate and statistically sound data analysis.
  • Balancing proactive monitoring requirements with cost and resource constraints.

Opportunities

  • PMS data can support product improvement and innovation.
  • Robust PMS systems enhance regulatory confidence and trust.
  • Digital tools and automation can streamline PMS data collection and analysis.

Self-Assessment Questions for Manufacturers

Manufacturers should assess their PMS systems against MDCG 2025-10 by considering the following questions:

  • Is the PMS plan proactive and proportionate to the device’s risk class?
  • Are diverse data sources being used effectively?
  • Do corrective actions ensure timely and appropriate responses to identified risks?
  • Is post-market surveillance fully integrated into the Quality Management System?

Need Expert Support?

If you have any questions or require support in addressing these topics for your products, please consult Sushvin – Best Quality and Regulatory Experts for Medical Devices in the UK for professional guidance.

Email us at info@sushvin.com | Medical Device Regulatory Updates - Monthly Newsletter | SUSHVIN Consultancy

References

Discover Our Range of Services

Sushvin provides a wide range of services designed to cater to the diverse needs of our clients. Our extensive service offerings include:

Subscribe To Our Newsletter

For Latest Updates, Subscribe to our monthly newsletter today!