Post-market surveillance and vigilance for devices MCQs With Answer

Introduction:

Post-market surveillance and vigilance are essential for ensuring the safety, performance, and continued regulatory compliance of medical devices after they enter the market. For M.Pharm students, understanding these systems helps link clinical outcomes with regulatory action, quality management, and risk mitigation. This topic covers post-market surveillance plans, adverse event reporting, trend analysis, post-market clinical follow-up (PMCF), field safety corrective actions, recalls, and interaction with regulatory authorities. Mastery of these concepts prepares pharmacists to contribute to complaint handling, vigilance reporting, root cause analysis, and corrective and preventive actions (CAPA), safeguarding patients while meeting national and international regulatory expectations.

Q1. What is the primary objective of a post-market surveillance (PMS) system for medical devices?

• To collect sales data for marketing purposes
• To monitor device performance and detect safety issues after market placement
• To replace pre-market clinical trials
• To reduce manufacturing costs

Correct Answer: To monitor device performance and detect safety issues after market placement

Q2. Which document typically describes the manufacturer’s systematic process for collecting and evaluating data from the field about a device?

• Device master record
• Post-market surveillance plan (PMS plan)
• Design history file
• Material safety data sheet

Correct Answer: Post-market surveillance plan (PMS plan)

Q3. In the context of device vigilance, which of the following best defines a “serious incident”?

• An event resulting in inconvenience to the user
• An incident that leads to or could lead to death or serious deterioration of health
• A routine maintenance issue
• A packaging defect without clinical consequence

Correct Answer: An incident that leads to or could lead to death or serious deterioration of health

Q4. What is the purpose of a Field Safety Corrective Action (FSCA)?

• To increase device sales in target markets
• To withdraw promotional materials from circulation
• To reduce risk by correcting or removing a marketed device that presents a safety issue
• To change the device classification

Correct Answer: To reduce risk by correcting or removing a marketed device that presents a safety issue

Q5. Which activity is a core element of trend reporting in post-market surveillance?

• Analyzing long-term patterns of non-serious complaints to identify emerging risks
• Measuring advertising reach
• Recording shipment delays
• Tracking supplier invoices

Correct Answer: Analyzing long-term patterns of non-serious complaints to identify emerging risks

Q6. Post-market clinical follow-up (PMCF) is primarily intended to:

• Replace pre-market safety data
• Generate ongoing clinical evidence to confirm the device’s safety and performance
• Market the device to clinicians
• Document manufacturing batch numbers

Correct Answer: Generate ongoing clinical evidence to confirm the device’s safety and performance

Q7. Which of the following best describes a manufacturer’s vigilance responsibility?

• Maintaining a marketing database
• Detecting, evaluating, reporting, and correcting incidents and safety issues
• Providing free replacements for all complaints
• Granting warranties to end users

Correct Answer: Detecting, evaluating, reporting, and correcting incidents and safety issues

Q8. Which regulatory requirement commonly mandates periodic safety update reports (PSURs) or equivalent for higher-risk devices?

• Routine inventory audits
• Periodic clinical evaluation and post-market surveillance outputs
• Packaging optimization studies
• Supplier qualification letters

Correct Answer: Periodic clinical evaluation and post-market surveillance outputs

Q9. What role does root cause analysis play in post-market surveillance?

• It identifies financial costs of recalls
• It determines the underlying cause of an incident to inform corrective actions
• It schedules marketing campaigns
• It certifies device labeling

Correct Answer: It determines the underlying cause of an incident to inform corrective actions

Q10. Which process is directly linked to implementing and verifying corrective and preventive actions (CAPA) after an adverse event?

• Design transfer
• Complaint handling and investigation
• Pre-market authorization
• Advertising approval

Correct Answer: Complaint handling and investigation

Q11. Which of the following is a key data source for a post-market surveillance program?

• Clinical complaint records, literature, registries, and user feedback
• Supplier brochures
• Internal HR documents
• Company annual party minutes

Correct Answer: Clinical complaint records, literature, registries, and user feedback

Q12. What is a “safety signal” in the context of device vigilance?

• An advertising tagline that resonates with clinicians
• An observed pattern of events or data that suggests a new or changed risk
• A manufacturer’s quality certificate
• A planned product enhancement

Correct Answer: An observed pattern of events or data that suggests a new or changed risk

Q13. Under many regulatory frameworks, which of the following actions is often required within a defined timeframe after becoming aware of a serious incident?

• Immediate redesign of the product
• Submission of a vigilance report to the competent authority
• Release of a press statement
• Termination of all manufacturing

Correct Answer: Submission of a vigilance report to the competent authority

Q14. Why is Unique Device Identification (UDI) important for post-market surveillance?

• It improves packaging aesthetics
• It facilitates traceability, rapid identification, and targeted corrective actions
• It encrypts patient data
• It replaces batch numbers

Correct Answer: It facilitates traceability, rapid identification, and targeted corrective actions

Q15. Which quality management standard explicitly supports post-market activities through requirements for feedback, complaint handling, and corrective actions?

• ISO 9001 only
• ISO 13485
• Good Laboratory Practice (GLP)
• ICH Q7

Correct Answer: ISO 13485

Q16. What is the main difference between a recall and a field safety corrective action?

• Recall is voluntary, FSCA is always mandatory
• Recall typically removes product from market; FSCA may include broader corrective measures including communications and updates
• Recall applies only to pharmaceuticals
• There is no difference; terms are interchangeable everywhere

Correct Answer: Recall typically removes product from market; FSCA may include broader corrective measures including communications and updates

Q17. What is the importance of post-market surveillance data for clinical evaluation?

• It provides commercial pricing benchmarks
• It supplies real-world evidence to confirm benefit-risk profile and to update clinical evaluation
• It replaces the need for pre-market testing
• It documents employee performance

Correct Answer: It supplies real-world evidence to confirm benefit-risk profile and to update clinical evaluation

Q18. Which of these is an expected output of an effective vigilance system?

• Faster product launches
• Timely detection and reporting of safety issues and implementation of effective corrective actions
• Reduced training requirements for users
• Increased warranty claims

Correct Answer: Timely detection and reporting of safety issues and implementation of effective corrective actions

Q19. How should manufacturers handle information that could indicate a public health threat?

• Delay reporting until internal meetings conclude
• Immediately assess and rapidly report to regulatory authorities per applicable timelines
• Only inform the local sales team
• Delete it from the complaint database

Correct Answer: Immediately assess and rapidly report to regulatory authorities per applicable timelines

Q20. Which activity helps prioritize risks identified through post-market surveillance for corrective action?

• Risk assessment and benefit-risk analysis
• Increasing production volume
• Designing new packaging
• Advertising the product to new markets

Correct Answer: Risk assessment and benefit-risk analysis

Download