Materiovigilance overview MCQs With Answer

Materiovigilance overview MCQs With Answer is designed specifically for M.Pharm students preparing for advanced clinical pharmacy practice. This set focuses on the principles, systems, and regulatory aspects of materiovigilance — the monitoring of adverse events and safety issues related to medical devices. Through 20 carefully crafted multiple-choice questions, students will deepen their understanding of device-related risk assessment, signal detection, reporting pathways, stakeholder roles, and post-market surveillance strategies. Each question targets conceptual clarity and application in clinical and regulatory contexts, enabling learners to confidently engage in materiovigilance activities, contribute to patient safety, and prepare for examinations and practice-oriented responsibilities in hospital, regulatory, and industry settings.

Q1. What is the primary objective of a materiovigilance system?

• To promote the sales of medical devices
• To monitor, detect, and prevent adverse events and risks associated with medical devices
• To replace pharmacovigilance
• To certify manufacturers for export

Correct Answer: To monitor, detect, and prevent adverse events and risks associated with medical devices

Q2. Which organisation serves as the National Coordination Centre for the Materiovigilance Programme of India (MvPI)?

• Central Drugs Standard Control Organization (CDSCO)
• Indian Pharmacopoeia Commission (IPC)
• All India Institute of Medical Sciences (AIIMS)
• National Institute of Biologicals (NIB)

Correct Answer: Indian Pharmacopoeia Commission (IPC)

Q3. Which of the following best describes a “medical device adverse event”?

• An expected beneficial effect when used as intended
• Any malfunction, deterioration in performance, or use error that may lead to patient harm
• A routine maintenance activity
• A marketing complaint about device aesthetics

Correct Answer: Any malfunction, deterioration in performance, or use error that may lead to patient harm

Q4. Unique Device Identification (UDI) is primarily used to:

• Provide a marketing code for distributors
• Enhance traceability and link devices to adverse event reports
• Prevent counterfeiting by encryption
• Replace device labeling

Correct Answer: Enhance traceability and link devices to adverse event reports

Q5. Which activity is a key component of post-market surveillance in materiovigilance?

• Pre-clinical animal studies
• Pre-market clinical investigation only
• Continuous collection and analysis of device performance and safety data after market entry
• Annual marketing meetings

Correct Answer: Continuous collection and analysis of device performance and safety data after market entry

Q6. What differentiates a device “malfunction” from an “adverse event” in materiovigilance terms?

• Malfunction refers to user dissatisfaction, while adverse event is always device failure
• Malfunction is a failure of the device to perform as intended; adverse event involves actual or potential patient harm
• They are synonyms and interchangeable
• Malfunction always leads to patient death, adverse event does not

Correct Answer: Malfunction is a failure of the device to perform as intended; adverse event involves actual or potential patient harm

Q7. Signal detection in materiovigilance primarily aims to:

• Identify marketing opportunities
• Detect new or changing patterns of device-related harm that warrant further investigation
• Increase device sales by promotional alerts
• Classify devices by price

Correct Answer: Detect new or changing patterns of device-related harm that warrant further investigation

Q8. Which stakeholder is NOT typically involved in reporting device-related adverse events?

• Healthcare professionals
• Patients and caregivers
• Device manufacturers
• Retail customers returning unopened devices for refund only

Correct Answer: Retail customers returning unopened devices for refund only

Q9. Root cause analysis (RCA) in materiovigilance is used to:

• Determine pricing strategies for devices
• Identify underlying factors that led to an adverse event and recommend corrective actions
• Increase the complexity of regulations intentionally
• Label devices with manufacturing dates

Correct Answer: Identify underlying factors that led to an adverse event and recommend corrective actions

Q10. How does materiovigilance differ from pharmacovigilance?

• Materiovigilance monitors drugs, pharmacovigilance monitors devices
• Materiovigilance focuses on safety of medical devices; pharmacovigilance focuses on safety of medicines
• There is no difference; both are identical programs
• Pharmacovigilance deals only with herbal products

Correct Answer: Materiovigilance focuses on safety of medical devices; pharmacovigilance focuses on safety of medicines

Q11. Which of the following best describes a “near miss” in the context of device safety?

• An event that caused permanent disability
• An incident that could have caused harm but did not, either by chance or timely intervention
• A deliberate misuse of the device resulting in harm
• A routine calibration check

Correct Answer: An incident that could have caused harm but did not, either by chance or timely intervention

Q12. What is a common initial step after receiving a serious device-related adverse event report?

• Immediate product recall without investigation
• Perform triage and preliminary assessment to determine seriousness, causality, and need for action
• Ignore the report if the device is under warranty
• Publicly release all patient identifiers in a safety notice

Correct Answer: Perform triage and preliminary assessment to determine seriousness, causality, and need for action

Q13. Which regulatory action may be taken based on materiovigilance findings?

• Issuance of safety alerts, field corrections, or device recalls
• Automatic approval of new devices
• Lifetime ban of all similar devices without evaluation
• Conversion of a device into a pharmaceutical product

Correct Answer: Issuance of safety alerts, field corrections, or device recalls

Q14. In evaluating causality between a device and an adverse event, which element is LEAST relevant?

• Temporal relationship between device use and event
• Plausibility of device causing the event based on mechanism
• Manufacturer’s marketing claims
• Other possible causes such as patient comorbidities or concomitant therapies

Correct Answer: Manufacturer’s marketing claims

Q15. Which international standard is most closely associated with quality management systems for medical device manufacturers?

• ISO 9001
• ISO 13485
• Good Laboratory Practice (GLP)
• ICH E6

Correct Answer: ISO 13485

Q16. Why is accurate device traceability important after an adverse event?

• To improve marketing analytics only
• To quickly identify affected lots, facilitate recalls, and inform exposed patients and users
• To reduce manufacturing costs directly
• To delay regulatory reporting

Correct Answer: To quickly identify affected lots, facilitate recalls, and inform exposed patients and users

Q17. Which element is typically included in a medical device adverse event report?

• Detailed event description, device identification, patient outcome, and reporter contact
• Company revenue for the year
• Only the device serial number without context
• Branding materials and promotional brochures

Correct Answer: Detailed event description, device identification, patient outcome, and reporter contact

Q18. What role can clinical pharmacists play in materiovigilance within a hospital?

• Only dispense devices without documenting issues
• Identify and report device-related incidents, participate in root cause analysis, and educate staff on safe device use
• Conduct only marketing for device suppliers
• Replace the need for regulatory authorities

Correct Answer: Identify and report device-related incidents, participate in root cause analysis, and educate staff on safe device use

Q19. Which statement about device recalls is true?

• All recalls are voluntary and do not involve regulators
• Recalls vary in urgency and scope, from advisory notices to complete market withdrawal based on risk assessment
• Recalls only apply to expired devices
• Recalls are initiated only after mass media reports

Correct Answer: Recalls vary in urgency and scope, from advisory notices to complete market withdrawal based on risk assessment

Q20. For effective materiovigilance data analysis, which practice improves the quality of signal detection?

• Ignoring duplicates and incomplete reports
• Standardized reporting formats, data harmonization, and active follow-up to complete critical information
• Relying solely on spontaneous reports without any proactive surveillance
• Publishing raw patient identifiers for community review

Correct Answer: Standardized reporting formats, data harmonization, and active follow-up to complete critical information

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