RAC Exam Prep - EU MDD/AIMDD & MDR UPDATED Exam Questions and CORRECT Answers
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Course
RAC
Institution
RAC
RAC Exam Prep - EU MDD/AIMDD &
MDR UPDATED Exam Questions and
CORRECT Answers
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
qual...
RAC Exam Prep - EU MDD/AIMDD &
MDR UPDATED Exam Questions and
CORRECT Answers
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
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
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
Define comparator device - Correct Answer- established device bearing a CE Mark that is
used as a reference in a clinical investigation NOT a predicate device like FDA)
What is the ISO for biocompatibility? - Correct Answer- ISO 10993
IEC 60601 regards - - Correct Answer- electrical safety and electric magnetic disturbance
The amount of a medical device's testing is/should be commensurate with - - Correct Answer-
it's potential RISK to human health
Name the two forms of clinical data used in CE marking - Correct Answer- 1. compilation of
relevant scientific literature currently available on the device's intended purpose, techniques
employed and critical evaluation of the compilation
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