RAC Device Quiz Questions and Answers (Graded A)

RAC Device Quiz Questions and

Answers (Graded A)


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 -

ANSWER-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 - ANSWER-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 - ANSWER-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"

Your US-based company has a medical device manufacturing site in the

Netherlands. It wishes to relocate that facility to Belgium. Which of the

following BEST describes the actions required?




A) No regulatory actions are required to move facilities within the EU