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RAC Exam Prep - EU MDD/AIMDD & MDR Study Aid with Complete Solutions
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RAC Exam Prep - EU MDD/AIMDD & MDR Study Aid with Complete SolutionsRAC Exam Prep - EU MDD/AIMDD & MDR Study Aid with Complete SolutionsRAC Exam Prep - EU MDD/AIMDD & MDR Study Aid with Complete SolutionsRAC Exam Prep - EU MDD/AIMDD & MDR Study Aid with Complete Solutions Similar but more detailed...

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  • September 29, 2024
  • 23
  • 2024/2025
  • Exam (elaborations)
  • Questions & answers

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  • rac exam prep eu mddaimdd mdr study aid with
  • rac exam prep eu mddaimdd mdr study aid stuvi
  • similar but more detailed than the essential requi

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RAC Exam Prep - EU MDD/AIMDD

& MDR Study Aid with Complete

Solutions


Similar but more detailed than the Essential Requirements - ANSWER-

General Safety and Performance Requirements




This ISO standard includes the most recent update to specific medical device

companies quality management system? - ANSWER-13485:2016




Which entity affixes it's identification number near the CE Mark? - ANSWER-

Notified Body, if involved in the conformity assessment




Un-classified devices not requiring CE mark - ANSWER-Custom-made,

Investigational, Compassionate/Orphan




All ----- contributing to the intended purpose must be considered - ANSWER-

Modes of action

,Define transient use - ANSWER-less than 60 minutes




Define short-term use - ANSWER-between 60 minutes and 30 days




What are the entities that make up the "economic operators"? - ANSWER-

manufacturers, Authorised Reps, importers, and distributors




When is a PMCF study mandatory? (MDD) - ANSWER-When CE marking is

based solely on clinical data from equivalent devices




A material is considered to have a biological effect if it actively and

intentionally ---- - ANSWER-induces, alters, or prevents a response from

tissues that is mediated by specific reactions at a molecular level




refers to a material's degradation within the body and metabolic elimination

of the resulting degradation products from the body - ANSWER-Absorption




Combination devices are most often classified as - ANSWER-Class III

, MEDDEV 2.4/1^7 is a guidance for - ANSWER-Classification under MDD




Standalone software is considered what type of device - ANSWER-Active




Software that drives a device or influences its use automatically falls in to

which classification? - ANSWER-That of the device




A clinical evaluation is required for - - ANSWER-every device, Class I through

III under all directives




If the literature shows new or other risks what may need to be updated? -

ANSWER-risk management plan




What is not required if a manufacturer can collect clinical evidence from

literature? - ANSWER-Clinical investigation




If a manufacturer and an NB cannot agree on the classification who is

consulted for a solution? - ANSWER-Competent Authority

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