RAC Exam - EU MDD/AIMDD & MDR NEWEST 2024- 2025
ACTUAL EXAM COMPLETE 120 QUESTIONS AND CORRECT
DETAILED ANSWERS (VERIFIED ANSWERS)
随着信息技术的迅猛发展，数字
时代已经成为现代社会的标志性
Which entity affixes it's identification number near the CE Mark? - (answer) Notified Body, if involved
in the conformity assessment
特征。互联网、大数据、人工智
能等技术的普及和应用，不仅深
刻地改变了人类的生产方式、生
Un-classified devices not requiring CE mark - (answer) Custom-made, Investigational,
Compassionate/Orphan
活方式和思维方式，也在全球范
围内引发了一系列深远的社会变
All ----- contributing to the intended purpose must be considered - (answer)
迁。在这样的背景下，探讨数字 Modes of action
时代对社会的影响及其对人类未
来的意义，具有重要的现实意义
Define transient use - (answer) less than 60 minutes
和理论价值。随着信息技术的迅
猛发展，数字时代已经成为现代
Define short-term use - (answer) between 60 minutes and 30 days
社会的标志性特征。互联网、大
数据、人工智能等技术的普及和
A material is considered to have a biological effect if it actively and intentionally ---- - (answer)
induces, alters, or prevents a 应用，不仅深刻地改变了人类的
response from tissues that is mediated by specific reactions at a molecular
level
生产方式、生活方式和思维方式
，也在全球范围内引发了一系列
深远的社会变迁。在这样的背景
refers to a material's degradation within the body and metabolic elimination of the resulting degradation
products from the body - (answer) Absorption
下，探讨数字时代对社会的影响
及其对人类未来的意义，具有重
Combination devices are most often classified as - (answer) Class III
要的现实意义和理论价值。随着
信息技术的迅猛发展，数字时代
已经成为现代社会的标志性特征
MEDDEV 2.4/1^7 is a guidance for - (answer) Classification under MDD
。互联网、大数据、人工智能等
技术的普及和应用，不仅深刻地
Standalone software is considered what type of device - (answer) Active
改变了人类的生产方式、生活方
式和思维方式，也在全球范围内
Software that drives a device or influences its use automatically falls in to which classification? -
(answer) That of the device引发了一系列深远的社会变迁。
在这样的背景下，探讨数字时代
对社会的影响及其对人类未来的
意义，具有重要的现实意义和理
论价值。
, If a manufacturer and an NB cannot agree on the classification who is consulted for a solution? -
(answer) Competent Authority
随着信息技术的迅猛发展，数字
How can a manufacturer appeal the CA's decision of a classification? - (answer) in the national courts
时代已经成为现代社会的标志性
特征。互联网、大数据、人工智
Define horizontal/Level I standards - (answer) General Standards relevant to all/wide range of
能等技术的普及和应用，不仅深
product types
刻地改变了人类的生产方式、生
活方式和思维方式，也在全球范
define Semi-horizontal/level 2 standards - (answer) requirements applicable to a range of similar
围内引发了一系列深远的社会变
products (surgical instruments)
迁。在这样的背景下，探讨数字
时代对社会的影响及其对人类未
Define vertical/level 3 standards - (answer) apply to a single product type or narrow range of
products 来的意义，具有重要的现实意义
和理论价值。随着信息技术的迅
猛发展，数字时代已经成为现代
Define comparator device - (answer) established device bearing a CE Mark that is used as a reference
in a clinical investigation NOT社会的标志性特征。互联网、大
a predicate device like FDA)
数据、人工智能等技术的普及和
应用，不仅深刻地改变了人类的
What is the ISO for biocompatibility? - (answer) ISO 10993
生产方式、生活方式和思维方式
，也在全球范围内引发了一系列
IEC 60601 regards - - (answer) electrical safety and electric magnetic disturbance
深远的社会变迁。在这样的背景
下，探讨数字时代对社会的影响
The amount of a medical device's testing is/should be commensurate with - - (answer) it's potential
及其对人类未来的意义，具有重
RISK to human health
要的现实意义和理论价值。随着
信息技术的迅猛发展，数字时代
Name the two forms of clinical data used in CE marking - (answer)
已经成为现代社会的标志性特征
1. compilation of relevant scientific literature currently available on the device's intended purpose,
。互联网、大数据、人工智能等
techniques employed and critical evaluation of the compilation
技术的普及和应用，不仅深刻地
2. results and conclusions of a specifically designed clinical investigation
改变了人类的生产方式、生活方
式和思维方式，也在全球范围内
What is contained in Annex 1 of the MDD, AIMDD and MDR? - (answer) Essential Requirements
引发了一系列深远的社会变迁。
(GSPRs in MDR)
在这样的背景下，探讨数字时代
对社会的影响及其对人类未来的
意义，具有重要的现实意义和理
论价值。
ACTUAL EXAM COMPLETE 120 QUESTIONS AND CORRECT
DETAILED ANSWERS (VERIFIED ANSWERS)
随着信息技术的迅猛发展，数字
时代已经成为现代社会的标志性
Which entity affixes it's identification number near the CE Mark? - (answer) Notified Body, if involved
in the conformity assessment
特征。互联网、大数据、人工智
能等技术的普及和应用，不仅深
刻地改变了人类的生产方式、生
Un-classified devices not requiring CE mark - (answer) Custom-made, Investigational,
Compassionate/Orphan
活方式和思维方式，也在全球范
围内引发了一系列深远的社会变
All ----- contributing to the intended purpose must be considered - (answer)
迁。在这样的背景下，探讨数字 Modes of action
时代对社会的影响及其对人类未
来的意义，具有重要的现实意义
Define transient use - (answer) less than 60 minutes
和理论价值。随着信息技术的迅
猛发展，数字时代已经成为现代
Define short-term use - (answer) between 60 minutes and 30 days
社会的标志性特征。互联网、大
数据、人工智能等技术的普及和
A material is considered to have a biological effect if it actively and intentionally ---- - (answer)
induces, alters, or prevents a 应用，不仅深刻地改变了人类的
response from tissues that is mediated by specific reactions at a molecular
level
生产方式、生活方式和思维方式
，也在全球范围内引发了一系列
深远的社会变迁。在这样的背景
refers to a material's degradation within the body and metabolic elimination of the resulting degradation
products from the body - (answer) Absorption
下，探讨数字时代对社会的影响
及其对人类未来的意义，具有重
Combination devices are most often classified as - (answer) Class III
要的现实意义和理论价值。随着
信息技术的迅猛发展，数字时代
已经成为现代社会的标志性特征
MEDDEV 2.4/1^7 is a guidance for - (answer) Classification under MDD
。互联网、大数据、人工智能等
技术的普及和应用，不仅深刻地
Standalone software is considered what type of device - (answer) Active
改变了人类的生产方式、生活方
式和思维方式，也在全球范围内
Software that drives a device or influences its use automatically falls in to which classification? -
(answer) That of the device引发了一系列深远的社会变迁。
在这样的背景下，探讨数字时代
对社会的影响及其对人类未来的
意义，具有重要的现实意义和理
论价值。
, If a manufacturer and an NB cannot agree on the classification who is consulted for a solution? -
(answer) Competent Authority
随着信息技术的迅猛发展，数字
How can a manufacturer appeal the CA's decision of a classification? - (answer) in the national courts
时代已经成为现代社会的标志性
特征。互联网、大数据、人工智
Define horizontal/Level I standards - (answer) General Standards relevant to all/wide range of
能等技术的普及和应用，不仅深
product types
刻地改变了人类的生产方式、生
活方式和思维方式，也在全球范
define Semi-horizontal/level 2 standards - (answer) requirements applicable to a range of similar
围内引发了一系列深远的社会变
products (surgical instruments)
迁。在这样的背景下，探讨数字
时代对社会的影响及其对人类未
Define vertical/level 3 standards - (answer) apply to a single product type or narrow range of
products 来的意义，具有重要的现实意义
和理论价值。随着信息技术的迅
猛发展，数字时代已经成为现代
Define comparator device - (answer) established device bearing a CE Mark that is used as a reference
in a clinical investigation NOT社会的标志性特征。互联网、大
a predicate device like FDA)
数据、人工智能等技术的普及和
应用，不仅深刻地改变了人类的
What is the ISO for biocompatibility? - (answer) ISO 10993
生产方式、生活方式和思维方式
，也在全球范围内引发了一系列
IEC 60601 regards - - (answer) electrical safety and electric magnetic disturbance
深远的社会变迁。在这样的背景
下，探讨数字时代对社会的影响
The amount of a medical device's testing is/should be commensurate with - - (answer) it's potential
及其对人类未来的意义，具有重
RISK to human health
要的现实意义和理论价值。随着
信息技术的迅猛发展，数字时代
Name the two forms of clinical data used in CE marking - (answer)
已经成为现代社会的标志性特征
1. compilation of relevant scientific literature currently available on the device's intended purpose,
。互联网、大数据、人工智能等
techniques employed and critical evaluation of the compilation
技术的普及和应用，不仅深刻地
2. results and conclusions of a specifically designed clinical investigation
改变了人类的生产方式、生活方
式和思维方式，也在全球范围内
What is contained in Annex 1 of the MDD, AIMDD and MDR? - (answer) Essential Requirements
引发了一系列深远的社会变迁。
(GSPRs in MDR)
在这样的背景下，探讨数字时代
对社会的影响及其对人类未来的
意义，具有重要的现实意义和理
论价值。
