RAC EU MDD/AIMDD & MDR EXAM 2025
RAC EU MDD/AIMDD & MDR EXAM 2025 WITH GUARANTEED ACCURATE
ANSWERS
Similar but more detailed than the Essential Requirements -
ACCURATE ANSWERS✔✔ General Safety and Performance
Requirements
This ISO standard includes the most recent update to specific medical
device companies quality management system? - ACCURATE
ANSWERS✔✔ 13485:2016
Which entity affixes it's identification number near the CE Mark? -
ACCURATE ANSWERS✔✔ Notified Body, if involved in the
conformity assessment
,Un-classified devices not requiring CE mark - ACCURATE
ANSWERS✔✔ Custom-made, Investigational, Compassionate/Orphan
All ----- contributing to the intended purpose must be considered -
ACCURATE ANSWERS✔✔ Modes of action
Define transient use - ACCURATE ANSWERS✔✔ less than 60 minutes
Define short-term use - ACCURATE ANSWERS✔✔ between 60
minutes and 30 days
A material is considered to have a biological effect if it actively and
intentionally ---- - ACCURATE ANSWERS✔✔ 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 -
ACCURATE ANSWERS✔✔ Absorption
Combination devices are most often classified as - ACCURATE
ANSWERS✔✔ Class III
MEDDEV 2.4/1^7 is a guidance for - ACCURATE ANSWERS✔✔
Classification under MDD
, Standalone software is considered what type of device - ACCURATE
ANSWERS✔✔ Active
Software that drives a device or influences its use automatically falls in
to which classification? - ACCURATE ANSWERS✔✔ That of the
device
If a manufacturer and an NB cannot agree on the classification who is
consulted for a solution? - ACCURATE ANSWERS✔✔ Competent
Authority
How can a manufacturer appeal the CA's decision of a classification? -
ACCURATE ANSWERS✔✔ in the national courts
Define horizontal/Level I standards - ACCURATE ANSWERS✔✔
General Standards relevant to all/wide range of product types
define Semi-horizontal/level 2 standards - ACCURATE ANSWERS✔✔
requirements applicable to a range of similar products (surgical
instruments)
Define vertical/level 3 standards - ACCURATE ANSWERS✔✔ apply to
a single product type or narrow range of products
RAC EU MDD/AIMDD & MDR EXAM 2025 WITH GUARANTEED ACCURATE
ANSWERS
Similar but more detailed than the Essential Requirements -
ACCURATE ANSWERS✔✔ General Safety and Performance
Requirements
This ISO standard includes the most recent update to specific medical
device companies quality management system? - ACCURATE
ANSWERS✔✔ 13485:2016
Which entity affixes it's identification number near the CE Mark? -
ACCURATE ANSWERS✔✔ Notified Body, if involved in the
conformity assessment
,Un-classified devices not requiring CE mark - ACCURATE
ANSWERS✔✔ Custom-made, Investigational, Compassionate/Orphan
All ----- contributing to the intended purpose must be considered -
ACCURATE ANSWERS✔✔ Modes of action
Define transient use - ACCURATE ANSWERS✔✔ less than 60 minutes
Define short-term use - ACCURATE ANSWERS✔✔ between 60
minutes and 30 days
A material is considered to have a biological effect if it actively and
intentionally ---- - ACCURATE ANSWERS✔✔ 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 -
ACCURATE ANSWERS✔✔ Absorption
Combination devices are most often classified as - ACCURATE
ANSWERS✔✔ Class III
MEDDEV 2.4/1^7 is a guidance for - ACCURATE ANSWERS✔✔
Classification under MDD
, Standalone software is considered what type of device - ACCURATE
ANSWERS✔✔ Active
Software that drives a device or influences its use automatically falls in
to which classification? - ACCURATE ANSWERS✔✔ That of the
device
If a manufacturer and an NB cannot agree on the classification who is
consulted for a solution? - ACCURATE ANSWERS✔✔ Competent
Authority
How can a manufacturer appeal the CA's decision of a classification? -
ACCURATE ANSWERS✔✔ in the national courts
Define horizontal/Level I standards - ACCURATE ANSWERS✔✔
General Standards relevant to all/wide range of product types
define Semi-horizontal/level 2 standards - ACCURATE ANSWERS✔✔
requirements applicable to a range of similar products (surgical
instruments)
Define vertical/level 3 standards - ACCURATE ANSWERS✔✔ apply to
a single product type or narrow range of products
