Post-Market Surveillance Flashcards

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

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

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

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

Answer: Initiate a field safety corrective action and notify relevant competent authorities

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

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

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

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

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

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

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.

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?

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

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.

Which element is MANDATORY in a PMS plan according to EU MDR Annex III?

Answer: A proactive and systematic procedure to collect and review post-market experience

EU MDR Annex III requires the PMS plan to specify a proactive, systematic procedure for gathering and reviewing post-market experience from clinical and non-clinical sources.

Under US MDR regulations, what is the consequence of a manufacturer failing to submit a required MDR within the mandated timeframe?

Answer: FDA may issue a Warning Letter, initiate seizure, or pursue injunctive relief

Failure to submit timely MDRs is a violation of 21 CFR Part 803 and can result in Warning Letters, injunctions, seizure actions, or civil money penalties.