System

Operates through MvPI supported by regular PSUR reporting.

PMS framework integrated within MDR/IVDR.

Combination of MDR reporting and Section 522 post-market studies.

PSUR / PMS Reporting

Applicable to every category of device.

PSUR applies to Class IIa–III categories, with PMSR applicable to Class I devices.

No PSUR mechanism; instead, MDR reporting and mandated studies apply.

Reporting Frequency

Reports every 6 months for the first two years, followed by annual submissions for the next two years.

Class III and IIb devices require annual reporting, Class IIa devices every two years, and Class I devices only when necessary.

Reports are only submitted in response to incidents.

Databases

Submissions made via Sugam Portal and IPC reporting forms.

Data uploaded into the EUDAMED database.

Information maintained in MAUDE and electronic MDR systems.

Adverse Event Reporting

Compulsory for manufacturers and importers; user reporting remains optional.

Serious events must be reported within 2–15 days, depending on severity.

Timelines: 10 days for fatalities, 30 days for injuries, and 5 days for serious risks.

Additional Obligations

Structured vigilance activities along with PSUR submission.

Need for a documented PMS approach supported by ongoing post-market clinical follow-up (PMCF)

Section 522 requires additional post-market studies for higher-risk products.

Philosophy

Emerging and progressively systematized.

Entirely lifecycle-oriented.

Predominantly reactive and targeted.

Transparency

Public access is limited.

Broad access provided through centralized EUDAMED system.

High transparency with data openly available via MAUDE.

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.

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.

Together, PMS and MvPI create a structured safety net that supports both regulatory compliance and patient protection.

Materiovigilance Programme of India (MvPI): To build a structured system for collecting and analyzing adverse event reports and device malfunctions.

• Initiated in 2015 to create a structured system for monitoring device safety

• Coordinated by:

  • CDSCO – Regulatory oversight.

  • Indian Pharmacopoeia Commission (IPC) – National monitoring & reporting.

  • 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.

Here’s how reporting works:

1. 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.

2. 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 “CDSCO Online Portal” – Sugam

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 platform provides a unique ID to help trace the status of the submission.

3. 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.

Reporting Timeframes (India):

1. Manufacturers/importers: Serious adverse events within 15 days.

2. 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.

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.

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) under Article 86 of the 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.

3. 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.

4. 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.

5. 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

6. 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

7. 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.