RAC Post-Market Surveillance 5

Question 1

What is the main function of the EUDAMED database in EU MDR post-market surveillance?

Accepted Answer

Centralized European database for device registration, UDI, and vigilance reporting

Answer

EUDAMED (European Database on Medical Devices) centralizes UDI data, economic operator registration, notified body involvement, and vigilance and market surveillance information.

Question 2

Which action is required when a manufacturer's PMS data shows that a device's benefit-risk profile is no longer acceptable?

Accepted Answer

Initiate a field safety corrective action and notify relevant competent authorities

Answer

When PMS data invalidates the benefit-risk profile, the manufacturer must take a field safety corrective action and report it to regulators as required.

Question 3

Under FDA's 522 Postmarket Surveillance Order authority, which device characteristic most often triggers a mandatory postmarket surveillance study order?

Accepted Answer

Implanted for more than one year or used in life-supporting applications

Answer

FDA issues 522 orders primarily for devices that are implanted, life-supporting, or life-sustaining, or where failure could cause serious adverse health consequences.

Question 4

Which of the following best describes the concept of 'state of the art' as applied to post-market surveillance under EU MDR?

Accepted Answer

The current best available technology, clinical evidence, and regulatory guidance relevant to the device

Answer

Under EU MDR, 'state of the art' encompasses the best current knowledge in technology, clinical evidence, and safety standards, and PMS must benchmark performance against it.

Question 5

A manufacturer discovers through PMS literature review that a competing device with the same intended use had a safety recall. What is the appropriate regulatory response?

Accepted Answer

Assess whether the same failure mode exists in their device and update the risk management file

Answer

Vigilance regarding equivalent or similar devices is a PMS obligation; competitor safety data must be evaluated to determine relevance to the manufacturer's own risk management file.

(RAC) Regulatory Affairs Certification Practice Test

(RAC) Regulatory Affairs Certification Practice Test

RAC Post-Market Surveillance 5