A Review on Medical Device Reporting: Navigating Voluntary Reporting System in Us FDA & India CDSCO

1. 1. Importance of Medical Device Reporting (MDR) in PMS

Medical devices are integral to modern healthcare, enabling the diagnosis, treatment, and monitoring of various medical conditions. From simple tools like syringes to advanced technologies such as implantable cardiac devices and robotic surgical systems, these devices have revolutionized patient care. However, their use is not without risks. Adverse events, device malfunctions, or improper use can lead to severe consequences, including patient harm, increased healthcare costs, and loss of trust in medical technologies (FDA, 2023; WHO, 2020)^{1, 2}. Medical Device Reporting (MDR) systems are critical for identifying and mitigating these risks. MDR serves as a key component of post-market surveillance, allowing regulators, manufacturers, and healthcare providers to monitor the safety and performance of devices after they enter the market. By collecting and analysing data on adverse events, near-misses, and device failures, MDR systems enable timely interventions such as recalls, design modifications, or updates to usage instructions³. This proactive approach not only enhances patient safety but also ensures that medical devices remain effective and reliable throughout their lifecycle⁴.

1. 2. Overview of medical device reporting systems

The medical device reporting (MDR) systems in the United States (US) and India are critical components of post-market surveillance, designed to monitor the safety and performance of medical devices after they enter the market. In the US, the Food and Drug Administration (FDA) oversees the MDR program under 21 CFR Part 803, which mandates manufacturers, importers, and device user facilities to report adverse events such as device-related deaths, serious injuries, and malfunctions⁸. Additionally, the FDA’s MedWatch program allows healthcare professionals, patients, and consumers to voluntarily report adverse events and product issues using Form 3500. The FDA also introduced the Voluntary Malfunction Summary Reporting (VMSR) Program, which enables manufacturers to submit quarterly summary reports for certain device malfunctions, streamlining the reporting process while maintaining oversight. These systems help the FDA identify safety trends, issue recalls, and improve device safety through data analysis and regulatory actions^{1, 13}. In India, the Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Devices Rules, 2017 and the Materiovigilance Programme of India (MvPI), launched in 2018¹¹. The MvPI encourages healthcare professionals and consumers to report adverse events related to medical devices, similar to the FDA’s MedWatch program. The program aims to build a robust post-market surveillance system by collecting and analysing data on device-related issues. In 2020, India expanded its regulatory scope by notifying all medical devices under the Drugs and Cosmetics Act, 1940, ensuring comprehensive oversight. The recent National Medical Devices Policy, 2023 further strengthens India’s regulatory framework, emphasizing post-market surveillance and the safe use of medical devices¹⁴.

1.3 Purpose of the Review: Comparing Voluntary Reporting Systems in the US FDA and           India CDSCO

Voluntary reporting systems play a crucial role in enhancing post-market surveillance by capturing data that might not be reported through mandatory channels. This review aims to:

• Provide a detailed comparison of the voluntary medical device reporting systems in the US FDA and India CDSCO^{11, 12}.
• Analyse the strengths and weaknesses of these systems, including their accessibility, usability, and effectiveness in capturing adverse events^{13, 14}.
• Highlight challenges such as underreporting, lack of awareness, and data quality issues that hinder the success of voluntary reporting^{11, 14}.
• Offer recommendations for improving voluntary reporting mechanisms in both countries, with a focus on enhancing public awareness, streamlining reporting processes, and leveraging technology¹³.

2. Regulatory Frameworks

The regulation of medical devices is shaped by the legal, economic, and healthcare contexts of each country. Two prominent regulatory frameworks are those of the United States Food and Drug Administration (US FDA) and the Central Drugs Standard Control Organization (CDSCO) in India.

2.1 Overview of medical device regulations in the US and India

US FDA: The FDA’s Center for Devices and Radiological Health (CDRH) is responsible for regulating medical devices in the United States. The FDA employs a risk-based classification system, categorizing devices into Class I (low risk), Class II (moderate risk), and Class III (high risk). Devices must undergo pre-market approval (PMA), 510(k) clearance, or De Novo classification depending on their risk level and intended use^{3, 9}. Post-market surveillance is a cornerstone of the FDA’s regulatory framework, with mandatory reporting required for manufacturers, importers, and device user facilities under 21 CFR Part 803. Additionally, the FDA’s voluntary reporting program, MedWatch, encourages healthcare professionals and patients to report adverse events and product issues^{7, 8}.

India CDSCO: In India, the regulation of medical devices is governed by the CDSCO under the Ministry of Health and Family Welfare. The Medical Device Rules, 2017, introduced a risk-based classification system (Class A, B, C, and D) and established a framework for the registration, manufacturing, and post-market surveillance of medical devices^{5, 10}. India’s regulatory framework is evolving, with increasing emphasis on strengthening post-market surveillance through initiatives like the Materiovigilance Program of India. MvPI, launched in 2015, aims to monitor the safety of medical devices through voluntary reporting by healthcare professionals and patients, with coordination by the Indian Pharmacopoeia Commission (IPC)⁶.

2.2 Brief History and Evolution of Medical Device Reporting (MDR) Systems in the US FDA and India CDSCO

The Medical Device Reporting (MDR) systems in the United States (US) and India have evolved over time to address the growing complexity of medical devices and the need for robust post-market surveillance. History and Evolution of Medical Device Reporting (MDR) Systems in the US FDA is described in fig (1).

3. Medical Device Reporting:

3.1 Definition and Scope of Medical Device Reporting (MDR)

Medical Device Reporting (MDR) refers to the systematic collection, analysis, and dissemination of data related to the safety and performance of medical devices after they have been marketed. MDR is a critical component of post-market surveillance, which aims to identify and mitigate risks associated with medical devices that may not have been evident during pre-market testing¹. The scope of MDR includes adverse events, device malfunctions, near-misses, and other issues that could compromise patient safety or device efficacy^{15, 16}.

3.2 Types of Reporting: Mandatory vs. Voluntary

Medical device reporting can be broadly categorized into mandatory and voluntary systems:

• Mandatory Reporting: Mandatory reporting is legally required for specific stakeholders, such as manufacturers, importers, and device user facilities. In the US, for example, the FDA mandates that manufacturers report adverse events, device malfunctions, and deaths under 21 CFR Part 803¹. Similarly, in India, the Medical Device Rules, 2017, require manufacturers to report serious adverse events to the CDSCO⁴. Mandatory reporting ensures that critical safety information is communicated to regulators in a timely manner.
• Voluntary Reporting: Voluntary reporting systems encourage healthcare professionals, patients, and other stakeholders to report adverse events or device issues without legal obligation. These systems complement mandatory reporting by capturing a broader range of data, including incidents that might otherwise go unreported. Examples include the FDA’s MedWatch program in the US and the Materiovigilance Program of India (MvPI) (CDRH, 2022; MvPI, 2023). Voluntary reporting is particularly important for identifying rare or long-term adverse events that may not be detected through mandatory channels¹⁶.

3.3 Key Stakeholders in Medical Device Reporting

Effective MDR systems rely on the active participation of multiple stakeholders^{2, 3, and 16}& below provided MDR process (flow table: fig: 2)

• Manufacturers: Manufacturers are often the first line of defence in identifying and reporting device-related issues. They are required to investigate adverse events, maintain records, and submit reports to regulatory authorities.
• Healthcare Professionals: Physicians, nurses, and other healthcare providers play a crucial role in recognizing and reporting adverse events or device malfunctions. Their first-hand experience with device use provides valuable insights into real-world performance².
• Patients: Patients and caregivers are increasingly recognized as important contributors to MDR. Patient-reported outcomes can highlight issues such as usability problems or long-term complications that may not be apparent to healthcare providers³.
• Device User Facility: Reports must be submitted to the manufacturer of the device no later than 10 work days after the day that it becomes aware of information that a device has or may have caused or contributed to a serious injury to a patient of the facility. If the manufacturer is unknown, the facility must submit the report to the FDA¹⁵.
• Regulators: Regulatory agencies, such as the US FDA and India CDSCO, are responsible for overseeing MDR systems, analysing reported data, and taking appropriate regulatory actions to protect public health⁵.

4. Voluntary Reporting Systems:

Voluntary reporting systems allow healthcare professionals, patients, and consumers to report adverse events, near-misses, and device malfunctions without legal obligations. These systems complement mandatory reporting by capturing data that might otherwise go unreported, providing a more comprehensive understanding of device performance in real-world settings. Voluntary reporting is crucial for identifying rare or long-term risks, improving device design, and enhancing patient safety^{1, 5}.

Role of Voluntary Reporting in Enhancing Patient Safety:

• Identifying Safety Signals: Detecting adverse events or device malfunctions that may not be captured through mandatory reporting.
• Improving Device Design: Providing feedback to manufacturers to enhance device safety and performance.
• Facilitating Regulatory Actions: Enabling regulatory authorities to issue safety alerts, recalls, or updates to device labeling.
• Engaging Stakeholders: Encouraging healthcare professionals and patients to actively participate in monitoring device safety¹³

The U.S. FDA employs several mechanisms for reporting medical device issues, including both mandatory and voluntary reporting systems. Mandatory reporting is required for manufacturers, importers, and device user facilities under the Medical Device Reporting (MDR) regulation (21 CFR Part 803). These entities must report adverse events and product problems that may have caused or contributed to deaths or serious injuries, as well as certain malfunctions that could lead to such outcomes if they recur^{15, 17}. In contrast, voluntary reporting is encouraged for healthcare professionals, patients, caregivers, and consumers, who can submit reports through the MedWatch program using Form FDA 3500^{15, 16}. In addition to the mandatory reporting requirements, the FDA offers the Voluntary Malfunction Summary Reporting (VMSR) Program. This program allows eligible manufacturers to submit quarterly summary reports of medical device adverse events, providing an alternative to submitting individual reports for each event²⁰. To report a medical device problem, individuals can use the MedWatch program for voluntary submissions. This involves completing the MedWatch Online Reporting Form or obtaining a form by phone or fax and submitting it to the FDA^{15, 17}. Mandatory reporters use Form FDA 3500A and can submit reports electronically through the Electronic Medical Device Reporting (eMDR) system, which streamlines the process and enhances data quality¹⁶. Key tools and platforms for reporting include MedWatch, which serves as the FDA's Safety Information and Adverse Event Reporting Program, and MAUDE (Manufacturer and User Facility Device Experience), a database that contains adverse event reports involving medical devices^18,19. The MAUDE database provides critical information on device safety and performance, aiding in the identification of potential safety issues¹⁹. Additionally, the eMDR system facilitates electronic submissions, offering benefits such as reduced administrative overhead and faster processing times¹⁶. FDA’s MedSun program allows healthcare facilities to voluntarily report adverse events and device problems. It focuses on high-risk devices and aims to improve post-market surveillance. Latest Update (2024) of MedSun is to FDA has expanded to include more healthcare facilities and encourages reporting of cybersecurity issues related to medical devices³⁴.

4.2 CDSCO Voluntary Reporting System

The Central Drugs Standard Control Organization (CDSCO) plays a pivotal role in regulating medical devices in India. The Medical Devices Rules, 2017, and subsequent amendments, such as the Medical Devices Rules, 2020, have significantly shaped the regulatory landscape²². Key regulations and guidelines include the requirement for manufacturers and importers to submit safety reports online, enhancing post-market surveillance²⁴. Additionally, the Materiovigilance Programme of India (MvPI) aims to make adverse event reporting mandatory for healthcare providers, further emphasizing CDSCO's commitment to patient safety⁶.  Consumers and patients in India can voluntarily report adverse events related to medical devices through the Materiovigilance Programme of India (MvPI), overseen by the Central Drugs Standard Control Organization (CDSCO). The MvPI was formally launched in 2015 at the Indian Pharmacopoeia Commission (IPC), which serves as the National Coordination Centre for the program¹⁰. This initiative aims to improve patient safety by monitoring adverse events associated with medical devices and ensuring their quality²⁷. To report an adverse event, individuals must first gather relevant details about the medical device, such as its name, model, manufacturer, and specifics of the incident, including the date, circumstances, and any harm caused. The next step involves filling out the Medical Device Adverse Event Reporting Form, which is available for download on the IPC website or directly through MvPI resources. This form requires information about the patient (while maintaining confidentiality), the reporter, the device, and a detailed description of the adverse event²³. Once completed, the form can be submitted in multiple ways:

• Online Submission: Via email to mvpi@ipcindia.net  or shatrunjay.ipc@gov.in.
• Postal Submission: Hard copies can be sent to IPC’s office in Ghaziabad.
• MDMC Submission: Forms can also be submitted to Medical Device Adverse Event Monitoring Centres (MDMCs), which are located across India. A list of MDMCs is available on the IPC website (https://ipc.gov.in/images/547_MDMC_Centre_Upload_Website.pdf ).

MvPI releases updated version of medical devices adverse event reporting form by actively participating in this voluntary reporting process, consumers and patients contribute to post-market surveillance efforts that enhance regulatory measures and patient safety across India²⁴.