How QSR Postmarket Surveillance Will Evolve Under the QMSR
As medical device manufacturers transition from the FDA’s Quality System Regulation (QSR) to the new Quality Management System Regulation (QMSR), one area undergoing significant change is postmarket surveillance.
Under the QSR, postmarket activities such as complaint handling and Medical Device Reporting (MDR) were treated as largely reactive compliance functions. With the QMSR’s incorporation of ISO 13485:2016, however, the emphasis shifts toward a more proactive, risk-based, and integrated approach to monitoring product performance once devices reach the market.
This evolution brings U.S. requirements into closer alignment with global expectations—particularly those in the EU and other markets—while raising the bar for how manufacturers detect, analyze, and respond to postmarket signals.
To prepare for QMSR compliance, companies will need to strengthen their quality feedback systems, refine data analysis practices, and ensure that complaint trends are linked to broader quality system processes like risk management and CAPA.
Major Differences Between QSR and QMSR PMS Expectations
Structure and Integration
QSR = Fragmented across complaint handling, CAPA, servicing, etc.
QMSR = Integrates PMS into a cohesive, risk-based quality management structure.
Proactivity
QSR = Primarily reactive (responding to complaints, failures).
QMSR = Adds proactive feedback, data analysis, and trend monitoring as formal expectations.
Global Alignment
QSR = U.S.-centric focus.
QMSR/ISO 13485 = Aligned with global regulatory expectations (EU MDR, MDSAP), supporting international compliance.
Documentation and Planning
QSR = No PMS plan or structured documentation required.
QMSR = Although ISO 13485 doesn’t use the term “PMS plan,” documented procedures are required, and planning consistent with EU-style PMS plans is considered best practice.
Overview of Changes
QMSR Info Request Form
Definitions
Affected Regulations and Standards
Assembling the Puzzle
Implementation Strategies
Small Manufacturers
Differences between the Current QSR and the Upcoming QMSR
PMS Activity QSR (21 CFR 820.20) QMSR with (ISO 13485:2016) Key Changes/Impact
Complaint Handling 820.198: Requires review, evaluation, investigation, and recordkeeping of complaints. Clause 8.2.2: Requires a documented complaint handling process with investigation and regulatory reporting. Functionally similar, but QMSR requires integration into overall monitoring/measurement activities.
Medical Device Reporting (MDR) 21 CFR Part 803 (not part of QSR but enforced in parallel). Clause 8.2.3: Requires procedures for reporting to regulatory authorities (global scope). MDR requirements continue; ISO 13485 brings them under formal PMS planning.
Nonconforming Product 820.90: Procedures for identifying and controlling nonconforming product. Clause 8.3: Expanded to include actions before and after delivery, including rework and customer feedback. Broader scope; requires linkage to risk management and continual improvement.
Corrective and Preventive Action (CAPA) 820.100: Requires investigation, cause determination, and corrective/preventive action. Clause 8.5.2–8.5.3: Emphasizes corrective actions, plus preventive action integrated into risk management. QMSR de-emphasizes standalone “preventive action,” embedding it in risk-based thinking.
Servicing 820.200: Requires evaluation of servicing data for quality problems. Clause 7.5.4: Similar requirements, with integration into broader feedback and monitoring system. QMSR encourages proactive analysis of service data as part of PMS.
Trend Analysis Not explicitly required under QSR (except under MDR 803.50(b)). Clause 8.4: Requires analysis of product and process data trends, including feedback, complaints, etc. New formal expectation for trend analysis and continuous improvement.
Postmarket Feedback System 820.198 (complaints), 820.100 (CAPA), but no centralized feedback system. Clause 8.2.1: Requires establishing processes for proactive feedback collection (not limited to complaints). Stronger emphasis on proactive collection of postmarket feedback.
PMS Planning & Documentation No explicit PMS plan or documentation required. ISO 13485 Annexes Z and ISO TR 20416 (guidance) recommend a documented PMS plan. Formal PMS plan becomes expected best practice—even if not explicitly required in the regulation.
Summary: Recommendations to Manufacturers for QMSR Compliance
- Create or enhance a documented process for collecting, analyzing, and responding to postmarket feedback—not just complaints.
- Implement trend analysis and data monitoring across all sources (complaints, servicing, production, etc.).
- Integrate risk management and CAPA with postmarket information.
- Be prepared to align PMS systems with international standards and regulatory reporting obligations (e.g., MDSAP, EU MDR), and
- Document and maintain procedures for regulatory reporting, including MDR compliance in the U.S. and others globally.