Post-Market Surveillance (PMS)

‍Post-Market Surveillance (PMS) refers to the active, systematic, and continuous monitoring of a medical device's performance, safety, and effectiveness after it has been commercially distributed. It is a mandatory regulatory requirement, especially for devices marketed in the United States (under the FDA) and the European Union (under the MDR/IVDR).

In simple terms, Post-Market Surveillance (PMS) is the formalized, scientifically valid process of collecting, analyzing, and interpreting data about a device that is already on the market to quickly identify any unforeseen problems, potential adverse events, or failure trends, ensuring the continued protection of public health.

PMS is critical because real-world use often reveals safety and effectiveness issues that were not apparent during premarket testing or approval phases.

Regulatory Basis and Requirements

PMS requirements are driven by specific regulations for Class II and Class III devices in the U.S. and are a fundamental part of the Quality Management System (QMS) in the EU.

A. U.S. FDA Requirements (21 CFR Part 822)

The FDA has the authority to order post-market surveillance under section 522 of the Federal Food, Drug, and Cosmetic Act.

• When PMS is Required: The FDA can order surveillance of any Class II or Class III medical device that meets specific criteria:
  • Failure of the device would be reasonably likely to have serious adverse health consequences.
  • The device is intended to be implanted in the human body for ** more than 1 year**.
  • The device is intended to support or sustain life and be used outside a user facility.
  • The device is expected to have significant use in pediatric populations.
• The Order and Plan: If required, the manufacturer receives a postmarket surveillance order (a letter) from the FDA. The manufacturer must submit a surveillance plan within 30 days of receiving the order.
• Plan Objectives: The surveillance plan must include a discussion of the plan objective(s) addressing the specific surveillance question(s) identified in the FDA's order. The plan must detail the surveillance approach, methodology, sample size, sources of data (e.g., hospital records), and the content and timing of reports.
• Duration: The FDA may order prospective surveillance for a period up to 36 months, but longer periods require the manufacturer's agreement.
• Consequences of Non-Compliance: Failure to have an approved PMS plan or failure to conduct surveillance in accordance with the approved plan constitutes a failure to comply with section 522 of the act, leading to the device being misbranded and the possibility of regulatory action.

B. EU MDR/IVDR Requirements

Postmarket Surveillance is explicitly mandated as an element of the QMS in the European Union.

• Mandatory QMS Component: The Medical Device Regulation (MDR) requires manufacturers to integrate the Postmarket Surveillance (PMS) system (as required by Article 10, 10 and specified in Article 83 of the Regulation) into their compliance framework.
• Monitoring and CAPA Integration: Manufacturers must monitor product performance, analyze post-market data, identify trends, investigate nonconformities, and implement corrective actions (CAPA), verifying their effectiveness.
• Vigilance Reporting: PMS is the source of issues that feed Vigilance Reporting (Medical Device Reporting/MDR) under EU MDR Article 87 and FDA 21 CFR 803, ensuring serious incidents and adverse events are systematically investigated and reported.

Implementation and Data Feedback Loop

Effective PMS relies on established procedures for collecting and analyzing data, which then feeds directly back into the QMS processes, particularly risk management and CAPA.

• Data Sources (Information Collection): The PMS plan must establish channels for collecting post-production data. These channels go beyond traditional complaints and include:
  • Information from the production process (e.g., in-process nonconformance data or production test data).
  • Information from the device user (e.g., electronic data from the device or customer surveys).
  • Information from installation and maintenance personnel.
  • Information generated by the supply chain.
  • Publicly available scientific literature and regulatory database searches for recalls and device incident data.
  • Information about the state of the art (e.g., data from conferences or technical journals).
• Integration with Risk Management: Post-production data must be reviewed to ensure the device's benefits continue to outweigh the risks. The international risk management standard, ISO 14971:2019, added increased requirements for post-market risk assessment, mandating manufacturers establish a system to collect and analyze data about products once launched to market. This data is fed back into the risk analysis to determine if new hazards have arisen or if existing risk estimates are inaccurate.
• Integration with CAPA: Safety issues identified through PMS, such as the identification and investigation of safety issues required under EU MDR Article 83, are followed by Corrective and Preventive Action (CAPA) when necessary. CAPA management ensures issues identified through post-market surveillance are resolved after product release.
• Reporting Requirements (PMA Holders): Holders of Premarket Approval (PMA) must comply with MDR requirements (Part 803) and submit periodic reports. These periodic reports must identify changes and contain a summary and bibliography of unpublished reports of data from clinical investigations or nonclinical studies and reports in the scientific literature concerning the device not previously submitted.

Record Keeping and Inspection

PMS activities generate records that are subject to inspection and must be maintained for specified periods.

• Records Required: Manufacturers must keep copies of all correspondence, the approved PMS plan (including documentation of any deviations), all data collected and analyses conducted, and investigator agreements.
• Record Retention: Records must be kept for a period of 2 years after the FDA has accepted the final report, unless otherwise specified.
• Inspection: The FDA can review PMS programs during regularly scheduled inspections, those initiated to investigate recalls or similar actions, or inspections initiated specifically to review the PMS plan. Manufacturers must be able to produce records within 72 hours of the inspection's initiation.

Analogy for Understanding Post-Market Surveillance (PMS)

If the premarket approval process (PMA) is like inspecting a car prototype in a controlled testing lab, Post-Market Surveillance (PMS) is like continuously monitoring the performance, maintenance records, and crash reports of every single model of that car sold worldwide. It uses a rigorous, structured system (the PMS Plan) to collect data on everything from minor customer complaints (nonconformities/CAPA) to serious, unforeseen safety failures (adverse events/MDR reporting). This constant feedback loop ensures that if a hidden defect emerges months or years after the car hits the road, the manufacturer is required to identify it, mitigate the risk (Risk Management), and fix the problem systematically (CAPA) to protect all drivers.

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