RAC Device Quiz Questions and Answers (Graded A)RAC Device Quiz Questions and Answers (Graded A)RAC Device Quiz Questions and Answers (Graded A)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 ...
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
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