RAC Exam Prep - EU MDD/AIMDD & MDR Exam Test Questions
with 100% Verified Answers graded A+
Similar but more detailed than the Essential ANSWERS - Absorption
Requirements - ANSWERS - General
Safety and Performance Requirements
Combination devices are most often classified as
- ANSWERS - Class III
This ISO standard includes the most recent
update to specific medical device companies
quality management system? - MEDDEV 2.4/1^7 is a guidance for -
ANSWERS - 13485:2016 ANSWERS - Classification under MDD
Which entity affixes it's identification number Standalone software is considered what type of
near the CE Mark? - ANSWERS - Notified device - ANSWERS - Active
Body, if involved in the conformity assessment
Software that drives a device or influences its use
Un-classified devices not requiring CE mark - automatically falls in to which classification? -
ANSWERS - Custom-made, ANSWERS - That of the device
Investigational, Compassionate/Orphan
If a manufacturer and an NB cannot agree on the
All ----- contributing to the intended purpose must classification who is consulted for a solution? -
be considered - ANSWERS - Modes of ANSWERS - Competent Authority
action
How can a manufacturer appeal the CA's
Define transient use - ANSWERS - less decision of a classification? - ANSWERS -
than 60 minutes in the national courts
Define short-term use - ANSWERS - Define horizontal/Level I standards -
between 60 minutes and 30 days ANSWERS - General Standards relevant to
all/wide range of product types
A material is considered to have a biological
effect if it actively and intentionally ---- - define Semi-horizontal/level 2 standards -
ANSWERS - induces, alters, or prevents a ANSWERS - requirements applicable to a
response from tissues that is mediated by range of similar products (surgical instruments)
specific reactions at a molecular level
Define vertical/level 3 standards -
refers to a material's degradation within the body ANSWERS - apply to a single product type
and metabolic elimination of the resulting or narrow range of products
degradation products from the body -
1/9
, RAC Exam Prep - EU MDD/AIMDD & MDR Exam Test Questions
with 100% Verified Answers graded A+
risk management plan
Define comparator device - ANSWERS -
established device bearing a CE Mark that is
used as a reference in a clinical investigation What is not required if a manufacturer can collect
NOT a predicate device like FDA) clinical evidence from literature? -
ANSWERS - Clinical investigation
What is the ISO for biocompatibility? -
ANSWERS - ISO 10993 State of the art = - ANSWERS - current
generally accepted technology and performance
output not to be confused with top-of-the-line.
IEC 60601 regards - - ANSWERS -
electrical safety and electric magnetic
disturbance FSCA - ANSWERS - Field Safety
Corrective Action
The amount of a medical device's testing
is/should be commensurate with - - ISO 14155 - ANSWERS - Clinical
ANSWERS - it's potential RISK to human investigations of medical devices in human
health subjects
Name the two forms of clinical data used in CE IB - ANSWERS - Investigators brochure -
marking - ANSWERS - 1. compilation of compilation of the current clinical and non-clinical
relevant scientific literature currently available on information on the investigational medical
the device's intended purpose, techniques device(s) relevant to the clinical investigation.
employed and critical evaluation of the
compilation
2. results and conclusions of a specifically CIR - ANSWERS - Clinical Investigation
designed clinical investigation report
What is contained in Annex 1 of the MDD, Whish entity is legally responsible for compliance
AIMDD and MDR? - ANSWERS - Essential with regulations and the first point of contact for
Requirements (GSPRs in MDR) EU authorities? - ANSWERS - Authorised
Representative (as applicable, if not the
manufacturer itself)
A clinical evaluation is required for - -
ANSWERS - every device, Class I through
III under all directives Which entity is liable for defective products in the
post market phase - ANSWERS -
Authorised rep
If the literature shows new or other risks what
may need to be updated? - ANSWERS -
2/9
with 100% Verified Answers graded A+
Similar but more detailed than the Essential ANSWERS - Absorption
Requirements - ANSWERS - General
Safety and Performance Requirements
Combination devices are most often classified as
- ANSWERS - Class III
This ISO standard includes the most recent
update to specific medical device companies
quality management system? - MEDDEV 2.4/1^7 is a guidance for -
ANSWERS - 13485:2016 ANSWERS - Classification under MDD
Which entity affixes it's identification number Standalone software is considered what type of
near the CE Mark? - ANSWERS - Notified device - ANSWERS - Active
Body, if involved in the conformity assessment
Software that drives a device or influences its use
Un-classified devices not requiring CE mark - automatically falls in to which classification? -
ANSWERS - Custom-made, ANSWERS - That of the device
Investigational, Compassionate/Orphan
If a manufacturer and an NB cannot agree on the
All ----- contributing to the intended purpose must classification who is consulted for a solution? -
be considered - ANSWERS - Modes of ANSWERS - Competent Authority
action
How can a manufacturer appeal the CA's
Define transient use - ANSWERS - less decision of a classification? - ANSWERS -
than 60 minutes in the national courts
Define short-term use - ANSWERS - Define horizontal/Level I standards -
between 60 minutes and 30 days ANSWERS - General Standards relevant to
all/wide range of product types
A material is considered to have a biological
effect if it actively and intentionally ---- - define Semi-horizontal/level 2 standards -
ANSWERS - induces, alters, or prevents a ANSWERS - requirements applicable to a
response from tissues that is mediated by range of similar products (surgical instruments)
specific reactions at a molecular level
Define vertical/level 3 standards -
refers to a material's degradation within the body ANSWERS - apply to a single product type
and metabolic elimination of the resulting or narrow range of products
degradation products from the body -
1/9
, RAC Exam Prep - EU MDD/AIMDD & MDR Exam Test Questions
with 100% Verified Answers graded A+
risk management plan
Define comparator device - ANSWERS -
established device bearing a CE Mark that is
used as a reference in a clinical investigation What is not required if a manufacturer can collect
NOT a predicate device like FDA) clinical evidence from literature? -
ANSWERS - Clinical investigation
What is the ISO for biocompatibility? -
ANSWERS - ISO 10993 State of the art = - ANSWERS - current
generally accepted technology and performance
output not to be confused with top-of-the-line.
IEC 60601 regards - - ANSWERS -
electrical safety and electric magnetic
disturbance FSCA - ANSWERS - Field Safety
Corrective Action
The amount of a medical device's testing
is/should be commensurate with - - ISO 14155 - ANSWERS - Clinical
ANSWERS - it's potential RISK to human investigations of medical devices in human
health subjects
Name the two forms of clinical data used in CE IB - ANSWERS - Investigators brochure -
marking - ANSWERS - 1. compilation of compilation of the current clinical and non-clinical
relevant scientific literature currently available on information on the investigational medical
the device's intended purpose, techniques device(s) relevant to the clinical investigation.
employed and critical evaluation of the
compilation
2. results and conclusions of a specifically CIR - ANSWERS - Clinical Investigation
designed clinical investigation report
What is contained in Annex 1 of the MDD, Whish entity is legally responsible for compliance
AIMDD and MDR? - ANSWERS - Essential with regulations and the first point of contact for
Requirements (GSPRs in MDR) EU authorities? - ANSWERS - Authorised
Representative (as applicable, if not the
manufacturer itself)
A clinical evaluation is required for - -
ANSWERS - every device, Class I through
III under all directives Which entity is liable for defective products in the
post market phase - ANSWERS -
Authorised rep
If the literature shows new or other risks what
may need to be updated? - ANSWERS -
2/9
