Vigilance Activities: Perspectives and Objectives

The WHO Global Model Regulatory Framework for Medical Devices, along with in vitro diagnostic medical devices, mandates the establishment of post-market surveillance systems, akin to various international regulatory frameworks. It emphasizes the necessity of receiving and assessing feedback as the fundamental components of post-market surveillance, with the potential for further expansion into additional endeavors. Furthermore, it encompasses the actions of national regulatory authorities (NRAs) in response to adverse event reports, commonly referred to as vigilance. Across different jurisdictions, "adverse event" may sometimes be substituted with "incident."

In the WHO Global Model Regulatory Framework for Medical Devices, post-market surveillance is primarily focused on NRA activities. In the context of this discussion, such activities carried out by NRAs are termed market surveillance. Herein, the term post-market surveillance is specifically reserved for actions undertaken by manufacturers.

The terms post-market surveillance, vigilance, and market surveillance are intricately intertwined. User experiences with medical devices are shared with manufacturers, who then report specific incidents to National Regulatory Authorities (NRAs) while keeping them informed of any subsequent actions taken. NRAs thoroughly review manufacturers' investigations and the ensuing measures. This process is integral to the market surveillance duties of NRAs.

Market surveillance encompasses a comprehensive set of activities conducted by NRAs to gain oversight of medical devices within their jurisdiction. Its aim is to guarantee the ongoing adequacy of safety, quality, and performance standards for medical devices available on the market.

Vigilance activities play a pivotal role in ensuring the continued safety and efficacy of devices post-market. These activities are carried out by both National Regulatory Authorities (NRAs) and manufacturers, each with their unique perspectives and objectives; 

Vigilance Activities by National Regulatory Authorities (NRAs)

From the perspective of NRAs, vigilance activities represent a critical component of their regulatory oversight responsibilities. These activities are primarily geared towards safeguarding public health by promptly identifying and addressing any potential risks associated with medical devices in circulation. Key objectives of vigilance activities conducted by NRAs include:

• Monitoring Adverse Events: NRAs systematically collect and evaluate reports of adverse events associated with medical devices. These reports serve as early warning signals, allowing NRAs to detect trends or patterns indicative of safety concerns.
• Assessment of Manufacturer Reports: NRAs meticulously review the investigations and reports submitted by manufacturers regarding adverse events. This scrutiny ensures that manufacturers adhere to regulatory requirements and take appropriate corrective actions when necessary.
• Risk Assessment and Management: NRAs conduct thorough risk assessments to evaluate the severity and likelihood of harm posed by identified issues. Based on these assessments, regulatory decisions are made to mitigate risks and protect public health.
• Communication and Transparency: NRAs foster transparent communication channels to disseminate safety-related information to healthcare professionals, patients, and the general public. Timely and clear communication is essential for building trust and facilitating informed decision-making.
• Enforcement Actions: In cases where serious non-compliance or safety issues are identified, NRAs may take enforcement actions, such as product recalls, market withdrawals, or imposing regulatory sanctions, to mitigate risks and ensure compliance with regulatory requirements.

Vigilance Activities by Manufacturers

From the perspective of manufacturers, vigilance activities are integral to fulfilling their regulatory obligations and maintaining product quality and safety standards. Manufacturers' vigilance activities aim to:

• Prompt Reporting of Adverse Events: Manufacturers are responsible for promptly reporting any adverse events or incidents associated with their medical devices to the relevant NRAs. Timely reporting enables swift regulatory intervention and risk mitigation measures.
• Investigation and Root Cause Analysis: Upon receiving reports of adverse events, manufacturers conduct thorough investigations to identify the root causes and contributing factors. This includes analyzing device design, manufacturing processes, user errors, and other relevant aspects to prevent recurrence.
• Corrective and Preventive Actions (CAPA): Based on the findings of investigations, manufacturers implement appropriate corrective and preventive actions to address identified issues and prevent future occurrences. These actions may include design modifications, labeling updates, or additional training for users.
• Post-Market Surveillance: Manufacturers establish robust post-market surveillance systems to continuously monitor the safety and performance of their devices in real-world settings. This ongoing surveillance enables manufacturers to proactively identify and respond to emerging risks or trends. 
• Collaboration with NRAs: Manufacturers collaborate closely with NRAs by providing timely and complete reports, responding to inquiries, and actively participating in regulatory discussions and initiatives aimed at enhancing device safety and regulatory compliance.

Post market surveillance has not been much developed in India. This may be due to the ignorance of healthcare professionals and also lack of training of drug safety monitoring. India is heavily dependent on the data generated in other countries, advisory notes issued and regulatory actions taken by regulators elsewhere. However, information obtained in one country may not be relevant to other parts of world where circumstances may differ. This makes it imperative upon us to generate Indian data, which would have greater relevance and educational value and may contribute to national regulatory decision making. Therefore, development of a strong pharmacovigilance system is important. The pharmacovigilance system comprises minimization of existing risks by providing training to healthcare professionals, safe care delivery of medical services, assessment of new risks by performing different methods of pharmacovigilance such as active or passive surveillance, analysis of safety data generated during pharmacovigilance methods, identifying preventable risks and development of risk minimization for such preventable risks. Post market surveillance is a dynamic clinical and scientific discipline. It provides reliable, balanced information for the effective assessment of the risk/benefit profile of medicines/medical devices.

Adverse Event Reporting and US FDA databases