RAC Devices Exam Questions and Answers Latest Updated 100% Fully Solved
What does the acronym MDR stand for?
A) Medical Device Regulation
B) Market Device Review
C) Medical Device Reporting
D) Manufacturer Device Regulation - Answer A) Medical Device Regulation
In the context of the E...
What does the acronym MDR stand for?
A) Medical Device Regulation
B) Market Device Review
C) Medical Device Reporting
D) Manufacturer Device Regulation - Answer ✔ A) Medical Device Regulation
In the context of the European Union, MDR refers to Regulation (EU) 2017/745, which
establishes the regulatory framework for medical devices to ensure their safety and
effectiveness within the EU market.
Which of the following best describes a Class I device?
A) High risk and requires PMA
B) Moderate risk and requires 510(k)
C) Low risk and subject to general controls
D) Requires clinical trials for approval - Answer ✔ C) Low risk and subject to general
controls
Class I devices are considered to be low-risk and are subject to general controls, which
include requirements for registration, labeling, and adherence to good manufacturing
practices. They generally do not require premarket approval (PMA) or 510(k) clearance,
though some may still require notification to the FDA.
Which regulation provides the framework for the approval of medical devices in
Canada?
A) Medical Device Regulation (MDR)
B) Food, Drug, and Cosmetic Act
C) Health Canada's Medical Devices Regulations
D) ISO 13485 - Answer ✔ C) Health Canada's Medical Devices Regulations
Health Canada's Medical Devices Regulations (Part of the Food and Drugs Act) outline
the requirements for the approval, classification, and monitoring of medical devices in
Canada. They govern the regulatory process for bringing medical devices to market in
the Canadian healthcare system.
, What is the purpose of the Labeling Requirements for medical devices in the U.S.?
A) To ensure that devices are marketed and promoted
B) To provide users with adequate instructions for use and safety information
C) To comply with international standards
D) To obtain CE marking - Answer ✔ B) To provide users with adequate instructions for
use and safety information
Labeling requirements are designed to ensure that medical devices are accompanied
by clear, accurate, and comprehensive information regarding their use, safety, and
performance. This information helps users operate the device correctly and understand
any potential risks associated with its use.
Which document is necessary for a U.S. manufacturer to demonstrate compliance with
quality system regulations?
A) Risk Management File
B) Device History Record (DHR)
C) Quality Manual
D) Clinical Evaluation Report - Answer ✔ C) Quality Manual
The Quality Manual is a crucial document that outlines the manufacturer's quality
management system, including policies, procedures, and responsibilities related to the
design, production, and control of medical devices. It serves as a comprehensive
reference for ensuring that the manufacturer meets the requirements of the Quality
System Regulation (QSR) under 21 CFR Part 820.
Which of the following is a primary regulatory body for medical devices in the United
States?
A) European Medicines Agency (EMA)
B) Medicines and Healthcare products Regulatory Agency (MHRA)
C) Food and Drug Administration (FDA)
D) Therapeutic Goods Administration (TGA) - Answer ✔ C) Food and Drug
Administration
What is the purpose of a 510(k) submission?
A) To obtain premarket approval for a high-risk device
B) To demonstrate that a device is substantially equivalent to a legally marketed device
C) To apply for a CE mark for European market entry
D) To report adverse events related to a device - Answer ✔ B) To demonstrate that a
device is substantially equivalent to a legally marketed device
Which of the following is true about ISO 13485?
A) It is a standard for environmental management systems
B) It provides guidelines for clinical trial design
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