Post-Market Surveillance (PMS) in Medical Devices : USA & EU
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As a regulatory leader, your responsibility doesn’t end with market approval, it begins there. This sentiment echoes across boardrooms and regulatory strategy meetings as post-market surveillance in medical devices (PMS) becomes a critical pillar of lifecycle management in medical devices. In the times where real-world performance, patient safety, and global compliance are under the spotlight, PMS is a strategic advantage.
According to global regulatory experts, the ability to predict, monitor, and act on post-market data is fast becoming a benchmark for excellence in medical device oversight. While the U.S. FDA and the European Union (EU) both prioritize PMS, their frameworks reflect two distinct philosophies: the FDA’s reactive yet data-driven model versus the EU’s proactive, lifecycle-integrated system under MDR 2017/745.
For companies with global aspirations, understanding these nuances in 2025 is essential to safeguarding brand reputation, achieve compliance, and maintain market access.
Understanding Post-Market Surveillance (PMS)
Post-Market Surveillance refers to the ongoing and systematic collection, analysis, and interpretation of data related to a medical device after it is placed on the market. It helps in identifying risks, evaluating benefit–risk ratios, and supporting regulatory actions such as safety communications, recalls, or labeling updates. PMS is also a fundamental input into the manufacturer’s Corrective and Preventive Action (CAPA) and Quality Management System (QMS) processes.
USA: PMS Requirements Under FDA Regulations
In the United States, PMS activities are primarily governed by 21 CFR Part 803, which covers Medical Device Reporting (MDR).
Key Stakeholders and Responsibilities
- Manufacturers & Importers: Must report device-related deaths, serious injuries, and certain malfunctions.
- User Facilities (e.g., hospitals): Required to report deaths to the FDA and serious injuries to manufacturers (or to the FDA if the manufacturer is unknown).
- Distributors: Not required to report routinely but must maintain records of complaints and provide them upon request.
Timelines for MDR Submission
- 30 calendar days for standard adverse event reports.
- 5 workdays for events requiring remedial action to prevent an unreasonable risk of substantial harm.
- 10 workdays for user facilities to report to the FDA or manufacturers, depending on the nature of the event.
Electronic Medical Device Reporting (eMDR)
Since 2015, all MDR submissions must be made electronically via the FDA’s Electronic Submissions Gateway (ESG). Manufacturers can use:
- eSubmitter software (for MedWatch 3500A XML files), or
- AS2 Gateway using HL7 ICSR-compliant XML formats.
MAUDE Database
Submitted MDRs are made publicly available through the Manufacturer and User Facility Device Experience (MAUDE) database, enhancing transparency and enabling stakeholders to monitor safety profiles.
Recent Developments (2023–2025)
While no major amendments to Part 803 have occurred, the FDA has released:
- Technical updates to the eMDR validation process,
- Guidance encouraging integration of real-world evidence (RWE), and
- Enhancements aligned with IMDRF harmonization goals.
Manufacturers are advised to track the CDRH eMDR enhancements schedule for the latest updates.
For more check out the blog post – https://resource.ddregpharma.com/insights/post-market-surveillance-pms-in-medical-devices-usa-eu-requirements/
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