When a medical device or in-vitro diagnostic (IVD) enters the market, regulatory approval is only the beginning. The true test lies in how the device performs in real-world conditions. That’s where Post-Market Surveillance (PMS) steps in.
PMS acts as the backbone of patient safety, ensuring that any risks are detected early, corrective actions are taken quickly, and devices continue to deliver safe and effective outcomes throughout their lifecycle.
This blog outlines how post-market surveillance is applied in India, Europe, and the United States, with a focus on their respective systems and regulatory obligations. A comparison table is included to illustrate the key distinctions.
Content Highlights:
Comparative Overview of PMS Frameworks: India, EU, and U.S.
India: Post-Market Surveillance (PMS) and Materiovigilance Programme of India (MvPI)
Post-Market Surveillance (PMS) is the overall framework that monitors medical devices after approval to ensure they remain safe and effective. Within this framework, the Materiovigilance Programme of India (MvPI) serves as the national system for reporting and analyzing device-related adverse events and malfunctions.
Together, PMS and MvPI create a structured safety net that supports both regulatory compliance and patient protection.
In simple terms:
- PMS = the broader requirement covering all post-approval monitoring activities (e.g., PSURs, risk assessments, recalls).
- MvPI = India’s dedicated vigilance programme focused on collecting and evaluating safety reports from manufacturers, hospitals, and even patients
Materiovigilance Programme of India (MvPI):- To build a structured system for collecting and analyzing adverse event reports and device malfunctions.
India’s Device Vigilance Framework
- Initiated in 2015 to create a structured system for monitoring device safety
- Coordinated by: CDSCO – Regulatory oversight, Indian Pharmacopoeia Commission (IPC) – National monitoring & reporting and AIIMS, New Delhi – Technical coordination.
Reporting Channels:
- Mandatory: Device manufacturers and importers regulated under the Medical Device Rules, 2017
- Voluntary: Hospitals, healthcare professionals, and even patients.
How to Report?
Unlike Europe’s EUDAMED or the U.S. FDA’s MAUDE/eMDR, India does not yet have a fully online, centralized reporting system for medical device vigilance. Instead, MvPI uses a form-based submission model, supported by email and postal channels.
For Healthcare Professionals, Hospitals, and Patients
- Reporting is voluntary but encouraged.
- Download the official MvPI reporting form from the IPC website.
- Provide information about the adverse event, device failure, or user complaint.
- Submit the completed form:
- By Email: [email protected]
- By Post:
Indian Pharmacopoeia Commission
Ministry of Health & Family Welfare
Sector-23, Raj Nagar, Ghaziabad – 201 002
- Update (2025): A separate online platform for MvPI reporting is not yet available.
For Manufacturers and Importers
- MDR 2017 makes it a legal requirement for manufacturers and importers to report adverse events.
- Reports must be filed through the CDSCO Sugam Online Portal, which allows submission, tracking, and acknowledgment of cases. The below explains the process:
How to Submit an Adverse Event Report for Medical Devices in India (MvPI):
- Visit Sugam Portal ——–>Go to Sugam “CDSCO Online Portal”
- Login / Register
- Manufacturers and importers must create a login using organizational details.
- Healthcare professionals/hospitals may report through institutional accounts.
- Navigate to Materiovigilance Section
- After logging in, choose Medical Device Division.
- Select the option for Adverse Event Reporting / Materiovigilance.
- Upload Information—-> Enter event details directly into the system or upload the filled MvPI adverse event reporting form.
- Submit and Track
- Submit the report.
- The portal generates a reference number for tracking.
Registered Medical Device Information Sharing Portal
In addition to reporting forms, IPC has created a Medical Device Information Sharing Portal, designed to collect details of registered devices, manufacturers, and suppliers. This supports MvPI by strengthening its device database and improving traceability.
Periodic Safety Update Reports (PSURs)
According to the CDSCO notice (File No. PSUR-13011(15)/1/2024, dated 19 March 2024,pdf Link), all PSURs for medical devices and IVDs are required to be filed only via the Online System for Medical Devices (Sugam portal) at https://www.cdscomdonline.gov.in.
From 1 April 2024, offline submission methods such as hard copy filings or email submissions will no longer be accepted. Applicants must ensure that PSURs are filed via the portal, following the prescribed checklist available within the system.
| Aspect | Details |
| Regulatory Basis | Mandatory under Medical Devices Rules (MDR), 2017 for all medical devices. |
| Submission Frequency | • Every 6 months for the first 2 years after approval • Annually for the following 2 years |
| Report Must Include | • Safety data and complaints received • Corrective or preventive actions taken • Updated benefit–risk assessment |
| Mode of Submission | Since April 2024, PSURs can only be submitted online via the CDSCO Sugam portal |
Reporting Timeframes (India):
- Manufacturers/importers: Serious adverse events within 15 days.
- Hospitals/user facilities: 15 days for serious events, 30 days for non-serious.
Post-Market Surveillance is a shared responsibility. By actively engaging with MvPI, PSUR submissions, and global vigilance practices, manufacturers can turn compliance into a competitive advantage.
US FDA : Post-Market Surveillance (PMS)
The U.S. Food and Drug Administration (FDA) has developed a comprehensive Post-Market Surveillance (PMS) system to detect risks early, enforce corrective measures, and preserve public confidence in medical technologies. Unlike pre-market evaluations, which are based on controlled studies with limited participants, PMS offers continuous real-world evidence from hospitals, clinics, and home-use environments.
FDA’s PMS Framework
The FDA regulates PMS through a combination of statutory obligations and guidance. Two major elements are:
- Medical Device Reporting Rule under 21 CFR 803
- Obligates manufacturers, importers, and user facilities to report specific adverse events.
- Applies to incidents of death, substantial injury, or serious failures connected to a device.
- Post-Market Surveillance Studies – Section 522 of the FD&C Act
- Gives FDA authority to require surveillance studies for certain Class II or III devices.
- Applied when a device poses potential risk, employs new technology, or requires additional long-term data.
Who Reports What?
- Manufacturers & Importers: Must report deaths, serious injuries, or malfunctions that could cause harm if they occurred again.
- User Facilities (e.g., hospitals, nursing homes): Must report deaths directly to FDA and manufacturers; serious injuries to the manufacturer (or FDA if manufacturer is unknown).
- Distributors: Do not submit MDRs but are required to maintain complaint files and provide them upon request.
Timelines for MDR Submission
- 30 calendar days → Standard adverse event reporting.
- 5 workdays → Urgent issues requiring immediate corrective action.
- 10 workdays → User facilities must report deaths or serious injuries.
Electronic Medical Device Reporting (eMDR)
- Since 2015, MDR reports have been required to be filed electronically via the FDA’s Electronic Submissions Gateway (ESG), using
- eSubmitter software (MedWatch Form FDA 3500A in XML format), or
- AS2 Gateway (HL7 ICSR-compliant XML).
This method enhances reporting efficiency, reliability, and traceability.
Transparency through the MAUDE Database
Every MDR submitted is made available in the MAUDE database, which supports:
- Public access to device safety data,
- Identification of safety patterns, and
- Enhanced accountability across the device industry.
Section 522 PMS Studies
For higher-risk devices, FDA may mandate a Section 522 surveillance study. Key requirements:
- Submission of a detailed study protocol for FDA approval.
- Regular progress reports until completion.
- May involve registries, post-approval clinical studies, or observational data.
These studies provide long-term safety insights and detect rare or delayed adverse events.
Recent Developments (2023–2025)
- Updates to eMDR validation processes to reduce rejection rates.
- Guidance promoting use of real-world evidence (RWE) from EHRs, registries, and digital health data.
- International Medical Device Regulators Forum alignment initiatives, harmonizing U.S. practices with international standards.
The FDA’s PMS system combines reactive reporting with targeted surveillance studies, making it both evidence-driven and adaptive. For medical device companies, PMS is not just about regulatory compliance—it’s an opportunity to strengthen patient safety, build trust, and use real-world data as a driver of innovation. A well-structured PMS strategy in the U.S. not only ensures regulatory adherence but also provides a significant advantage in the marketplace.
Europe : Post-Market Surveillance (PMS)
When it comes to medical device safety, the European Union has built one of the most proactive post-market systems worldwide. The EU Medical Device Regulation (MDR 2017/745,pdf Link) places a strong emphasis on continuous monitoring and lifecycle evaluation, ensuring devices remain safe and effective long after they reach the market.
Post-Market Surveillance (PMS) Plan
All manufacturers must include a PMS plan within their Technical documentation. This plan acts as the foundation for vigilance and must specify:
- Data sources to be used (complaints, literature, registries, etc.)
- Methods for data collection and analysis
- Timelines for evaluations and reporting
- Strategies for addressing identified risks
A well-structured PMS plan ensures a systematic approach to monitoring device safety and performance.
Periodic Safety Update Reports (PSURs) – Article 86 MDR
PSURs are one of the cornerstones of PMS under MDR:
- Applicable to Class IIa–III devices, while Class I devices follow simplified PMS reporting.
- Contents must cover:
- Summaries of safety and performance data
- Updated benefit–risk evaluation
- Corrective and preventive actions (CAPA)
- Findings from Post-Market Clinical Follow-Up (PMCF)
- Sales and usage data
- Frequency:
- Annually for Class IIb and III devices
- Every two years for Class IIa devices
All PSURs must be uploaded to EUDAMED, the EU’s centralized electronic database, making them accessible to regulators and, in some cases, the public.
Vigilance & Serious Incident Reporting
It is mandatory for manufacturers to notify competent authorities of critical incidents or FSCAs. Timelines depend on the severity of the event:
- Within 2 days for incidents posing a public health threat
- A 10-day reporting deadline applies in cases involving fatalities or serious harm.
- Within 15 days for all other reportable incidents
This strict reporting framework ensures rapid regulatory response when risks emerge.
Post-Market Clinical Follow-Up (PMCF)
PMCF is a proactive requirement under MDR. It involves gathering additional clinical data from real-world use to confirm safety and performance.
- Especially important for high-risk or innovative devices
- Results from PMCF are incorporated into the PSUR and risk management file, supporting continuous risk evaluation.
MDCG Guidance on PSURs (MDCG 2022-21)
In December 2022, the Medical Device Coordination Group (MDCG) released guidance to support manufacturers. This document outlines:
- Use of IMDRF codes for standardized reporting
- A structured format (device description, executive summary, data tables, CAPA, benefit–risk evaluation)
- Templates provided in Annex I
- The obligation to continue reporting until the device’s full expected lifetime (including shelf life)
Transparency Through EUDAMED
The EUDAMED database acts as the EU’s central hub for PMS:
- Regulators across member states can access and share vigilance data
- Healthcare professionals and the public benefit from greater transparency
- Supports harmonization across the EU single market
Recent Developments (2023–2025)
- Progressive rollout of EUDAMED modules covering vigilance, PMS, and market surveillance
- Stronger emphasis on data quality, traceability, and harmonization
- Alignment with IMDRF standards for global consistency
EU post-market surveillance adopts a proactive, methodical, and lifecycle-oriented framework. With requirements such as PMS plans, PSURs, PMCF, and strict vigilance timelines, Europe ensures that medical devices are continuously evaluated even after approval.
For manufacturers, this is more than a regulatory obligation—it’s an opportunity to demonstrate ongoing commitment to patient safety, build trust with regulators, and secure long-term market access across all 27 EU member states.
Conclusion
Post-Market Surveillance (PMS) plays a central role in medical device regulation, helping protect patients well beyond the point of market approval.
- India has strengthened its system through the Materiovigilance Programme of India (MvPI) and the mandatory submission of PSURs, creating a more organized safety monitoring framework.
- Europe has taken a step further by embedding PMS into the entire lifecycle of a device, supported by structured tools such as PSURs, PMS plans, and the EUDAMED database.
- The U.S. FDA follows a robust event-driven model, combining mandatory adverse event reporting with targeted post-market studies, while making data accessible through public databases for greater transparency.
For companies operating across borders, recognizing these differences is essential. A clear understanding of regional expectations not only ensures compliance but also strengthens relationships with regulators, healthcare providers, and patients by reinforcing a commitment to safety and accountability.
At Morulaa, we don’t just help you enter the Indian market—we ensure your devices stay compliant, safe, and trusted through complete PMS and vigilance support. With our expertise and dedicated support, you can focus on expanding your business while we ensure that your devices meet India’s evolving safety and compliance standards.