The European Commission’s Medical Device Coordination Group (MDCG) has released new guidance clarifying postmarket surveillance (PMS) expectations for medical device and in vitro diagnostic manufacturers operating under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The guidance reinforces that PMS is not a standalone regulatory obligation, but a continuous, lifecycle-based process that must be fully embedded within a manufacturer’s quality management system (QMS).
As EU regulatory oversight continues to intensify, the guidance provides important clarification on how manufacturers should structure, execute, and sustain compliant PMS systems.
PMS as a Continuous Lifecycle Requirement
MDCG emphasizes that postmarket surveillance begins once a device is placed on the market and continues throughout the entire intended lifetime of the product. Manufacturers are expected to systematically collect, document, and analyze postmarket data on an ongoing basis, rather than relying on periodic or reactive assessments.
This lifecycle-based approach aligns with the core intent of MDR and IVDR, which require manufacturers to continuously confirm that devices maintain acceptable safety, performance, and benefit-risk profiles during real-world use.
Integration With the Quality Management System
The guidance makes clear that PMS must be fully integrated into the QMS. Manufacturers are expected to establish appropriate organizational structures, documented procedures, defined processes, and sufficient resources to support effective surveillance activities.
MDCG also highlights the importance of management oversight. The effectiveness of the PMS system should be reviewed at the executive level, including through formal management review processes, ensuring that postmarket insights inform risk management, product improvement, and regulatory decision-making.
PMS Planning and Data Collection Expectations
Manufacturers are encouraged to begin developing their PMS plans early, ideally during product development. PMS plans may apply to individual devices or groups of devices and should clearly define what will be monitored, how often monitoring will occur, and which methods will be used.
The guidance stresses that PMS activities should be risk-based and proportionate to device classification, intended use, and novelty. Relevant data sources may include healthcare professionals, patients, complaints, scientific literature, registries, and real-world use data. Manufacturers remain responsible for ensuring data quality and integrity prior to analysis.
Analysis, Risk Management, and Continuous Improvement
Once PMS data are collected, manufacturers must analyze and evaluate the information to confirm ongoing compliance with safety and performance requirements. The guidance notes that data should be assessed in the context of similar devices where appropriate and used to identify emerging risks, trends, or previously unknown issues.
If concerns are identified, manufacturers are expected to initiate corrective and preventive actions in accordance with their risk management and quality procedures.
How EMMA International Supports MDR and IVDR PMS Compliance
At EMMA International, we support medical device and IVD manufacturers in building, optimizing, and sustaining MDR- and IVDR-compliant postmarket surveillance systems. Our services include PMS strategy development, QMS integration, risk-based PMS planning, regulatory gap assessments, and readiness support for notified body and competent authority interactions.
As EU expectations continue to evolve, EMMA partners with organizations to move beyond compliance checklists and implement PMS frameworks that support product quality, regulatory confidence, and long-term market access across Europe.
