RAC device Quiz Questions With Complete Solutions 2023-

RAC device Quiz Questions With Complete Solutions 2023-2024

EU: Which of the following does NOT describe the CE Mark or its use?

A) The CE Mark is an external indication that a device meets the Essential Requirements

B) The manufacturer and/or the Notified Body have checked the device against specifications using a ConformityAssessment Procedure

C) A Declaration of Conformity has been produced by the manufacturer

D) The CE Mark allows the device to move freely throughout Europe only

[Ans: - D) The CE Mark allows the device to move freely throughout Europe only

EU: The following are components of routine risk minimisation EXCEPT:

A) Adding protective measures in the manufacturing process

B) Application of relevant standards

C) An evaluation of the need for risk minimisation activities

D) A marketing plan

[Ans: - D) A marketing plan

EU: Classification of medical devices is based upon all of the following EXCEPT the:

A) Device's intended purpose

B) Device's implantability

C) Devise invasiveness

D) Device's indications for use

[Ans: - D) Device's indications for use

Note: MDR Chapter V Article 51: "Devices shall be divided into classes I, IIa, IIb and III, taking into account the intended purpose of the devices and their inherent risks"

EU: Which of the following does NOT describe a "custom device”?

A) It is made specifically in accordance with a duly qualified medical practitioner's written prescription, which gives specific design characteristics

B) The manufacturer and/or the Notified Body have checked the device against specifications using a Conformity Assessment Procedure

C) It is intended for the sole use of a particular patient

D) The device cannot exhibit the CE Mark to move freely throughout Europe

[Ans: - B) The manufacturer and/or the Notified Body have checked the device against specifications using a Conformity Assessment Procedure