RAC Post-Market Surveillance Questions and Answers 1 — 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?
- File a Medical Device Report (MDR) with the FDA within 5 working days.
- Immediately initiate a Class I recall and notify all customers.
- Investigate the complaints as part of the formal complaint handling process to determine the root cause and assess the risk. (Correct answer)
- Note the events and summarize them in the next annual report to the FDA.
Correct answer: Investigate the complaints as part of the formal complaint handling process to determine the root cause and assess the risk.
According to the FDA's Quality System Regulation (21 CFR 820.198), manufacturers must have procedures for receiving, reviewing, and evaluating complaints. The required initial action is to investigate the issue to understand its root cause, frequency, and potential risk. This investigation will determine if further actions, such as a Medical Device Report (MDR) or a recall/correction, are necessary. Acting without a proper investigation would be premature.
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?
- To gather marketing data and user preferences for the next product generation.
- To proactively collect and evaluate clinical data to confirm the safety and performance of the device throughout its expected lifetime. (Correct answer)
- To fulfill the reporting requirements for individual serious adverse events to competent authorities.
- To replace the need for pre-market clinical investigation data for high-risk devices.
Correct answer: To proactively collect and evaluate clinical data to confirm the safety and performance of the device throughout its expected lifetime.
The EU MDR, Annex XIV, Part B, defines Post-Market Clinical Follow-up (PMCF) as a continuous process to update the clinical evaluation. Its main purpose is to proactively gather clinical data on a CE-marked device to confirm its ongoing safety and performance and to ensure the continued acceptability of identified risks.
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?
- Within 10 working days
- Within 30 calendar days (Correct answer)
- Within 5 working days
- This event does not require a report
Correct answer: Within 30 calendar days
According to 21 CFR 803.50(a)(2), a manufacturer must submit a Medical Device Report (MDR) no later than 30 calendar days after becoming aware of information that reasonably suggests a device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
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?
- A Post-Market Surveillance Report (PMSR)
- A Medical Device Report (MDR)
- An Annual Clinical Evaluation Report (CER)
- A Periodic Safety Update Report (PSUR) (Correct answer)
Correct answer: A Periodic Safety Update Report (PSUR)
According to Article 86 of the EU MDR (2017/745), manufacturers of Class IIa, IIb, and III devices must prepare a Periodic Safety Update Report (PSUR). For Class IIb and III devices, this report must be updated at least annually and made available to the Notified Body.
Question 5: Which of the following activities is the BEST example of proactive post-market surveillance?
- Investigating a customer complaint about a device failure.
- Conducting a customer survey to gather data on device usability and performance in a real-world setting. (Correct answer)
- Submitting a vigilance report to a competent authority after a serious injury.
- Issuing a field safety corrective action to address a known product defect.
Correct answer: Conducting a customer survey to gather data on device usability and performance in a real-world setting.
Proactive post-market surveillance involves activities initiated by the manufacturer to actively search for information about a device's performance, rather than waiting for events to be reported. A customer survey is a method of actively seeking out this information. Investigating complaints, submitting vigilance reports, and issuing corrections are all reactive measures taken in response to an identified issue or event.
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?
- Management Review
- Risk Management (Correct answer)
- Supplier Controls
- Design Controls
Correct answer: Risk Management
Post-market surveillance is a critical input to the risk management process, as described in ISO 14971. Data gathered from the market is used to review and update the risk management file, confirming that risk controls are effective and identifying any new hazards. This creates a continuous feedback loop, ensuring the risk profile of the device remains accurate throughout its lifecycle.
RAC Post-Market Surveillance Questions and Answers 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?