RAC Post-Market Surveillance Questions and Answers

Question 1

A manufacturer of a Class II medical device in the U.S. receives several customer complaints about a software glitch that causes the device to temporarily freeze.
No patient injury has been reported, and the issue is resolved by rebooting the device.
What is the most appropriate initial action for the manufacturer?

Accepted Answer

Investigate the complaints as part of the formal complaint handling process to determine the root cause and assess the risk.

Answer

File a Medical Device Report (MDR) with the FDA within 5 working days.

Answer

Immediately initiate a Class I recall and notify all customers.

Answer

Note the events and summarize them in the next annual report to the FDA.

Question 2

Under the EU Medical Device Regulation (MDR 2017/745), which of the following is a primary objective of a Post-Market Clinical Follow-up (PMCF) plan?

Accepted Answer

To proactively collect and evaluate clinical data to confirm the safety and performance of the device throughout its expected lifetime.

Answer

To gather marketing data and user preferences for the next product generation.

Answer

To fulfill the reporting requirements for individual serious adverse events to competent authorities.

Answer

To replace the need for pre-market clinical investigation data for high-risk devices.

Question 3

A manufacturer becomes aware that its marketed medical device has malfunctioned. Although the event did not cause a death or serious injury, the manufacturer determines that if the malfunction were to recur, it would be likely to cause or contribute to a death or serious injury. Under US FDA regulations (21 CFR 803), how soon must the manufacturer report this event?

Accepted Answer

Within 30 calendar days

Answer

Within 10 working days

Answer

Within 5 working days

Answer

This event does not require a report

Question 4

A manufacturer of a Class IIb implantable device, which is CE Marked under the EU MDR, must periodically prepare a comprehensive post-market surveillance document for review by their Notified Body. What is this report called?

Accepted Answer

A Periodic Safety Update Report (PSUR)

Answer

A Post-Market Surveillance Report (PMSR)

Answer

A Medical Device Report (MDR)

Answer

An Annual Clinical Evaluation Report (CER)

Question 5

Which of the following activities is the BEST example of proactive post-market surveillance?

Accepted Answer

Conducting a customer survey to gather data on device usability and performance in a real-world setting.

Answer

Investigating a customer complaint about a device failure.

Answer

Submitting a vigilance report to a competent authority after a serious injury.

Answer

Issuing a field safety corrective action to address a known product defect.

Question 6

The systematic collection and analysis of real-world data from post-market surveillance serves as a primary input for the continuous update of which other key quality system process?

Accepted Answer

Risk Management

Answer

Management Review

Answer

Supplier Controls

Answer

Design Controls