RAC Exam - EU MDDA / MDD MDR NEWEST ACTUAL EXAM
COMPLETE 130 QUESTIONS AND CORRECT DETAILED ANSWERS/
GRADE A+ ASSURED
1. Similar but more detailed than the Essential Requirements: General Safety and
Performance Requirements
2. This ISO standard includes the most recent update to specific medical device
companies quality management system?: 13485:2016
3. Which entity affixes it's identification number near the CE Mark?: Notified Body, if
involved in the conformity assessment
4. Un-classified devices not requiring CE mark: Custom-made, Investigational,
Compassionate/Orphan
5. All ----- contributing to the intended purpose must be considered: Modes of action
6. Define transient use: less than 60 minutes
7. Define short-term use: between 60 minutes and 30 days
8. A material is considered to have a biological effect if it actively and intentionally
----: induces, alters, or prevents a response from tissues that is mediated by specific
reactions at a molecular level
9. Refers to a material's degradation within the body and metabolic elimination of the
resulting degradation products from the body: Absorption
10. Combination devices are most often classified as: Class III
11. MEDDEV 2.4/1^7 is a guidance for: Classification under MDD
12. Standalone software is considered what type of device: Active
13. Software that drives a device or influences its use automatically falls in to which
classification?: That of the device
14. If a manufacturer and an NB cannot agree on the classification who is consulted
for a solution?: Competent Authority
15. How can a manufacturer appeal the CA's decision of a classification?: in the national
courts
16. Define horizontal/Level I standards: General Standards relevant to all/wide range of
product types
17. Define Semi-horizontal/level 2 standards: requirements applicable to a range of
similar products (surgical instruments)
18. Define vertical/level 3 standards: apply to a single product type or narrow range
of products
19. Define comparator device: established device bearing a CE Mark that is used as a
reference in a clinical investigation NOT a predicate device like FDA)
20. What is the ISO for biocompatibility?: ISO 10993
21. IEC 60601 regards -: electrical safety and electric magnetic disturbance
22. The amount of a medical device's testing is/should be commensurate with
, -: it's potential RISK to human health
23. Name the two forms of clinical data used in CE marking: 1. Compilation of relevant
scientific literature currently available on the device's intended purpose, techniques
employed and critical evaluation of the compilation
2. Results and conclusions of a specifically designed clinical investigation
24. What is contained in Annex 1 of the MDD, AIMDD and MDR?: Essential
Requirements (gsprs in MDR)
25. A clinical evaluation is required for -: every device, Class I through III under all
directives
26. If the literature shows new or other risks what may need to be updated?: -
Risk management plan
27. What is not required if a manufacturer can collect clinical evidence from
literature?: Clinical investigation
28. State of the art =: current generally accepted technology and performance output
not to be confused with top-of-the-line.
29. FSCA: Field Safety Corrective Action
30. ISO 14155: Clinical investigations of medical devices in human subjects
31. IB: Investigators brochure - compilation of the current clinical and non-clinical
information on the investigational medical device(s) relevant to the clinical investigation.
32. CIR: Clinical Investigation report
33. Whish entity is legally responsible for compliance with regulations and the first
point of contact for EU authorities?: Authorised Representative (as applicable, if not the
manufacturer itself)
34. Which entity is liable for defective products in the post market phase: Authorised rep
35. EMA: European Medicines Agency
36. Define EC type-examination: NB body reviews and, at times, performs device testing
37. The post market surveillance concept is concept is addressed in these two ISO
standards: 13485 and 14971
38. The criteria and procedures used by mfr's, CA's and other interested parties to
notify and handle incidents and FSCA's or recalls are known col- lectively as the -:
Medical Device Vigilance System
39. GPSD: General Product Safety Directive
40. What are the entities that make up the "economic operators"?: manufactur- ers,
Authorised Reps, importers, and distributors
41. When is a PMCF study mandatory? (MDD): When CE marking is based solely on clinical
data from equivalent devices
42. PSUR: Periodic Safety Update Report
COMPLETE 130 QUESTIONS AND CORRECT DETAILED ANSWERS/
GRADE A+ ASSURED
1. Similar but more detailed than the Essential Requirements: General Safety and
Performance Requirements
2. This ISO standard includes the most recent update to specific medical device
companies quality management system?: 13485:2016
3. Which entity affixes it's identification number near the CE Mark?: Notified Body, if
involved in the conformity assessment
4. Un-classified devices not requiring CE mark: Custom-made, Investigational,
Compassionate/Orphan
5. All ----- contributing to the intended purpose must be considered: Modes of action
6. Define transient use: less than 60 minutes
7. Define short-term use: between 60 minutes and 30 days
8. A material is considered to have a biological effect if it actively and intentionally
----: induces, alters, or prevents a response from tissues that is mediated by specific
reactions at a molecular level
9. Refers to a material's degradation within the body and metabolic elimination of the
resulting degradation products from the body: Absorption
10. Combination devices are most often classified as: Class III
11. MEDDEV 2.4/1^7 is a guidance for: Classification under MDD
12. Standalone software is considered what type of device: Active
13. Software that drives a device or influences its use automatically falls in to which
classification?: That of the device
14. If a manufacturer and an NB cannot agree on the classification who is consulted
for a solution?: Competent Authority
15. How can a manufacturer appeal the CA's decision of a classification?: in the national
courts
16. Define horizontal/Level I standards: General Standards relevant to all/wide range of
product types
17. Define Semi-horizontal/level 2 standards: requirements applicable to a range of
similar products (surgical instruments)
18. Define vertical/level 3 standards: apply to a single product type or narrow range
of products
19. Define comparator device: established device bearing a CE Mark that is used as a
reference in a clinical investigation NOT a predicate device like FDA)
20. What is the ISO for biocompatibility?: ISO 10993
21. IEC 60601 regards -: electrical safety and electric magnetic disturbance
22. The amount of a medical device's testing is/should be commensurate with
, -: it's potential RISK to human health
23. Name the two forms of clinical data used in CE marking: 1. Compilation of relevant
scientific literature currently available on the device's intended purpose, techniques
employed and critical evaluation of the compilation
2. Results and conclusions of a specifically designed clinical investigation
24. What is contained in Annex 1 of the MDD, AIMDD and MDR?: Essential
Requirements (gsprs in MDR)
25. A clinical evaluation is required for -: every device, Class I through III under all
directives
26. If the literature shows new or other risks what may need to be updated?: -
Risk management plan
27. What is not required if a manufacturer can collect clinical evidence from
literature?: Clinical investigation
28. State of the art =: current generally accepted technology and performance output
not to be confused with top-of-the-line.
29. FSCA: Field Safety Corrective Action
30. ISO 14155: Clinical investigations of medical devices in human subjects
31. IB: Investigators brochure - compilation of the current clinical and non-clinical
information on the investigational medical device(s) relevant to the clinical investigation.
32. CIR: Clinical Investigation report
33. Whish entity is legally responsible for compliance with regulations and the first
point of contact for EU authorities?: Authorised Representative (as applicable, if not the
manufacturer itself)
34. Which entity is liable for defective products in the post market phase: Authorised rep
35. EMA: European Medicines Agency
36. Define EC type-examination: NB body reviews and, at times, performs device testing
37. The post market surveillance concept is concept is addressed in these two ISO
standards: 13485 and 14971
38. The criteria and procedures used by mfr's, CA's and other interested parties to
notify and handle incidents and FSCA's or recalls are known col- lectively as the -:
Medical Device Vigilance System
39. GPSD: General Product Safety Directive
40. What are the entities that make up the "economic operators"?: manufactur- ers,
Authorised Reps, importers, and distributors
41. When is a PMCF study mandatory? (MDD): When CE marking is based solely on clinical
data from equivalent devices
42. PSUR: Periodic Safety Update Report
