By: Miriam Sharif-Murray, M.S., RAC, Nerac Analyst

Medical device manufacturers operating globally face a growing challenge: post-market surveillance systems that satisfy EU MDR requirements do not automatically meet FDA expectations under the new QMSR. As regulators shift toward proactive, data-driven oversight, gaps between these frameworks can create compliance risk, audit findings, and operational inefficiencies. This shift is exemplified by the introduction of the Medical Device Regulations (MDR) in the European Union (EU) and the adoption of the Quality Management System Regulation (QMSR) in the United States.

While these regulatory changes signal a movement toward harmonization of the regulatory approach of these two regions, practical differences still exist in their implementation. The EU requires scheduled, benefit-risk reevaluation based on the device’s lifecycle for almost all risk classes.  By contrast, the FDA utilizes a more targeted, risk-stratified approach in which they require post-market studies for select high-risk devices at the time of approval and use adverse event reporting to trigger “for cause” surveillance when field signals emerge. These differences are not just procedural—they create real risk for manufacturers attempting to operationalize a single, global quality system.

A hallmark feature of the EU MDR post–market system is the Periodic Safety Update Report (PSUR). The PSUR follows a formalized, periodic reporting structure and demonstrates that the manufacturer has complied with requirements outlined in Articles 83–86 of the MDR. It is a structured summary of the analysis and conclusions of the post–market activities performed for the device. PSURs are mandatory for moderate to high-risk devices, namely class IIa/IIb/III and implantables. PSURs must be updated at least every two years for Class IIa devices and annually for Class IIb and III devices and submitted to the Notified Body.

The PSUR is a part of a device’s technical documentation, and its findings are integrated throughout the technical file.  It is linked to risk management file updates, feeds clinical evaluation report (CER) revisions, informs post–market clinical follow up (PMCF) planning and reporting, and it creates a structured analysis of vigilance reporting.  The EU MDR mandates that manufacturers establish a quality management system (QMS) and that post–market surveillance (PMS) and clinical evaluation be a part of the QMS. Furthermore, manufacturers must establish a procedure for management review in which the data used to compile a PSUR is examined (see our recent article Medical Device Post–market Surveillance in the EU: PMCF, PMSR, and PSUR for more details).

The FDA does not prescribe a periodic document that is analogous to the PSUR in which sales volume, patient exposure, and trend analysis are compiled.  However, the QMSR codifies the requirement for a proactive feedback loop in which information about whether the device has met customer requirements is gathered and monitored; this includes information about the safety and performance of a device after it has been marketed.

Furthermore, QMSR now grants the FDA greater access to a manufacturer’s records. Previously, section 21 CFR 820.180(c) of the QSR shielded management reviews, quality audits, and supplier audit reports from being reviewed by the FDA. During an FDA audit, the regulation only required a written certification from an employee in management verifying that management reviews and internal quality audits had been carried out and properly documented.  The QMSR excludes section 820.180(c), and with the adoption of ISO 13485, allows for transparency and access to the aforementioned records. The FDA now has authority to evaluate the substance of management’s deliberations to ensure that findings and trends from the data used to generate documents, such as the PSURs, are actively used to mitigate risk and drive product and process improvement.

These changes in the regulatory landscape mean that manufacturers should take a unified global approach to FDA and EU post–market compliance rather than addressing them as two separate efforts. For instance, a safety signal identified while compiling data for a PSUR should trigger an evaluation that is documented within the manufacturer’s complaint handling system and quality systems. Under QMSR, compliance relies on a traceable chain of activities in which the manufacturer evaluated whether any new trends existed or new hazards emerged.

What will FDA expect to see in practice?

Risk Management: Evidence within the risk management file that the benefit-risk determinations were reassessed based on emerging data.

Corrective and Preventive Actions (CAPA): Evidence that field signals or adverse events appropriately trigger investigations and subsequent actions. 

Management Review: Evidence that executive leadership actively reviewed post-market trends and incorporated them into the quality system and continuous improvement activities.

Fundamentally, EU MDR reporting outputs, such as PSURs, should not be treated as “EU-only” documents. They should be handled as structured, periodic summaries of PMS data to be integrated into a QMSR–compliant process. Manufacturers who successfully establish a quality system that can translate PSUR findings into risk management, management review, and continuous improvement activities will be better positioned to demonstrate compliance across jurisdictions while also optimizing the overall effectiveness of their post–market surveillance programs.

Why Consider Nerac?

Navigating the evolving expectations of EU MDR and FDA QMSR requires more than regulatory awareness—it demands a cohesive, data-driven approach to post-market surveillance that integrates seamlessly into your quality system.

Nerac supports medical device manufacturers in developing and operationalizing unified global PMS strategies that align with both EU and U.S. regulatory expectations. Our team brings deep expertise in post-market surveillance, clinical evaluation, and risk management to help ensure that critical outputs—such as PSURs—are not only compliant, but fully leveraged across your quality system.

We assist organizations in:

• Developing and refining PMS systems that meet EU MDR and QMSR requirements
• Integrating PSUR findings into risk management, CAPA, and management review processes
• Supporting CER and PMCF activities with robust post-market data analysis
• Identifying gaps and preparing for FDA inspections and Notified Body audits
• Streamlining documentation and processes to reduce compliance risk and operational burden

By translating regulatory requirements into practical, audit-ready systems, Nerac enables manufacturers to move beyond fragmented compliance efforts and towards a proactive, globally aligned post-market strategy.

To learn how Nerac can support your post-market surveillance initiatives or evaluate how your current PMS system aligns with both EU MDR and FDA QMSR expectations, contact our team.

About the Analyst

Miriam is a regulatory and medical writing expert with over 20 years of experience in the medical device industry. She brings deep expertise in post-market surveillance, technical documentation, and global regulatory compliance, with hands-on experience supporting product lifecycles from development through post-market.

Prior to joining Nerac, Miriam held roles in both industry and scientific publishing, including serving as Regulatory Affairs Manager at Royal Philips, where she oversaw compliance for a portfolio of medical devices across global markets. She has also supported the development of technical files, standard operating procedures, and clinical manuscripts published in leading scientific journals.

Miriam holds an M.S. in Biology from Tennessee State University and a B.A. in Biology from Fisk University.  Click here to learn more and view other articles by Miriam.

About the Analyst

Miriam Sharif-Murray, M.S.

Miriam Sharif-Murray brings over 20 years of medical device/regulatory experience to Nerac clients. After completing her degrees, she worked as a chemist for chemical and medical device manufacturers where she further strengthened her scientific knowledge and built her expertise in the regulatory environment.

Academic Credentials

• M.S., Biology, Tennessee State University
• B.A., Biology, Fisk University