RAC Device Quiz & Answers Correct Review Solution

RAC Device Quiz & Answers Correct Review Solution 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 MDR: 'custom-made device' means any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person's professional qualifications which gives, under that person's responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs. 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?... CONTINUES...