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
& 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
