RAC device quiz questions | Q&A Latest 2024/2025 | 100% PASS

RAC device quiz questions | Q&A Latest 2024/2025 | 100% PASS 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