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RAC EXAM - EU MDD/AIMDD & MDR
|ACTUAL EXAM WITH COMPLETE
QUESTIONS AND 100% VERIFIED
ANSWERS|ACE YOUR SCORES
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
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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
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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
What is an FSCA also referred to as? - CORRECT-ANSWER-(Field Safety
Corrective Action) aka Recall or withdrawal
When an FSCA is implemented the mfr must send copies of the FSN to -
- CORRECT-ANSWER-1. CA's in countries where FSCA is performed
2. affected customers
3. If NB involved for conformity assessment, FSN should also be sent to
CA in member state where NB is located
When should a trend report be submitted? - CORRECT-ANSWER-If
there is a significant increase in -
1. already reported incidents
2. incidents usually exempt from reporting
RAC EXAM - EU MDD/AIMDD & MDR
|ACTUAL EXAM WITH COMPLETE
QUESTIONS AND 100% VERIFIED
ANSWERS|ACE YOUR SCORES
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
, Page 2 of 29
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
, Page 3 of 29
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
What is an FSCA also referred to as? - CORRECT-ANSWER-(Field Safety
Corrective Action) aka Recall or withdrawal
When an FSCA is implemented the mfr must send copies of the FSN to -
- CORRECT-ANSWER-1. CA's in countries where FSCA is performed
2. affected customers
3. If NB involved for conformity assessment, FSN should also be sent to
CA in member state where NB is located
When should a trend report be submitted? - CORRECT-ANSWER-If
there is a significant increase in -
1. already reported incidents
2. incidents usually exempt from reporting
