Materiovigilance Programme of India (MvPI): Medical Device Safety
Introduction
The Materiovigilance Programme of India (MvPI) is a national programme for monitoring the safety of medical devices. It aims to identify, collect, analyse, and assess adverse events associated with medical devices so that risks can be reduced and patient safety improved.
The Indian Pharmacopoeia Commission (IPC) plays a key role in the programme.
What is materiovigilance?
Materiovigilance refers to the systematic monitoring of adverse events and safety issues associated with medical devices.
Examples of medical devices include:
Pacemakers.
Orthopaedic implants.
Surgical instruments.
Catheters.
Infusion pumps.
Diagnostic devices.
Certain medical software and connected devices, depending on their regulatory classification.
Objectives
Detect previously unrecognised device-related risks.
Monitor adverse events after devices enter clinical use.
Improve the reporting of device-related incidents.
Support corrective and preventive actions.
Strengthen public confidence in medical devices.
How the programme works
A suspected adverse event or device malfunction is identified.
The event is reported through the relevant reporting mechanism.
Available information is assessed for possible association with the device.
Safety signals are analysed.
Appropriate regulatory or risk-reduction measures may be considered.
UPSC Prelims Key Pointers
Full form: Materiovigilance Programme of India.
Key institution: Indian Pharmacopoeia Commission.
Purpose: Monitoring adverse events associated with medical devices.
It differs from pharmacovigilance, which primarily concerns the safety of medicines.
The Central Drugs Standard Control Organisation (CDSCO) is India's central drug regulatory authority.
Medical device safety monitoring is important even after a device has received regulatory approval.
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