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RAC Exam Prep - EU Exam Questions and Answers
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RAC Exam Prep - EU Exam Questions and Answers
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RAC Exam Prep - EU Exam Questions andAnswers
Similar but more detailed than the Essential Requirements -
Correct Answer ✅ General Safety and Performance
Requirements
This ISO standard includes the most recent update to specific
medical device companies quality management system? -
Correct Answer ✅ 13485:2016
Which entity affixes it's identification number near the CE
Mark? - Correct Answer ✅ Notified Body, if involved in the
conformity assessment
Un-classified devices not requiring CE mark - Correct
Answer ✅ Custom-made, Investigational,
Compassionate/Orphan
All ----- contributing to the intended purpose must be
considered - Correct Answer ✅ Modes of action
Define transient use - Correct Answer ✅ less than 60
minutes
,RAC Exam Prep - EU Exam Questions and
Answers
Define short-term use - Correct Answer ✅ between 60
minutes and 30 days
A material is considered to have a biological effect if it
actively and intentionally ---- - Correct 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 - Correct Answer ✅ Absorption
Combination devices are most often classified as - Correct
Answer ✅ Class III
MEDDEV 2.4/1^7 is a guidance for - Correct Answer ✅
Classification under MDD
Standalone software is considered what type of device -
Correct Answer ✅ Active
, RAC Exam Prep - EU Exam Questions and
Answers
Software that drives a device or influences its use
automatically falls in to which classification? - Correct
Answer ✅ That of the device
If a manufacturer and an NB cannot agree on the
classification who is consulted for a solution? - Correct
Answer ✅ Competent Authority
How can a manufacturer appeal the CA's decision of a
classification? - Correct Answer ✅ in the national courts
Define horizontal/Level I standards - Correct Answer ✅
General Standards relevant to all/wide range of product types
define Semi-horizontal/level 2 standards - Correct Answer
✅ requirements applicable to a range of similar products
(surgical instruments)
Define vertical/level 3 standards - Correct Answer ✅ apply
to a single product type or narrow range of products
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