RAPS PRACTICE TEST QUESTIONS &
ANSWERS SOLVED 100% CORRECT!!
1 of 87
Term
The number of times a recognized hazardous situation occurs when
a device is used as intended is higher than the manufacturer
expected. Which action should the manufacturer take?
A. Immediately recall the product
B. Continue to gather data to see if this trend continues
C. Revise labelling to inform user
D. Feed this information back to the risk management process
Give this one a try later!
, D. Feed this information back
A. Accounting for product labeling to the risk management
pre- and post-processing process
A. Device fails to comply with any A. CE marking under MDD
paragraph of the QSR 93/42/EEC is sufficient
Don't know?
2 of 87
Term
An article published in scientific journal based on experiences in
Korean hospital indicates there are problems with use of a mfger's
CE-marked device. Medical intervention was necessary to prevent
serious injury; however, it was determined FSCA is not necessary.
Whom should mfger inform of the situation?
A. CA
B. NB
C. EU Commission
D. No reporting is required
Give this one a try later!
D. No reporting is required B. Compatibility and safety
A. CE marking under MDD
A. Document control manager
93/42/EEC is sufficient
, Don't know?
3 of 87
Term
A US based manufacturer produces a Class I medical device with a
CE mark that is sold in Germany. The authorized representative is
located in the Netherlands. An identical medical device is sold
outside of the EU. An incident is reported in Japan and leads to an
FSCA. The US based manufacturer immediately identifies the
problem and makes a change to a mold to prevent future incidents.
Whom should the US based manufacturer inform of the situation?
A. Appropriate authorities outside the EU
B. CA in Germany
C. CA in Netherlands
D. NB
Give this one a try later!
D. Initiate the manufacturer's CAPA
C. CA in Netherlands
process
C. Market retrieval of product D. No reporting is required
Don't know?
4 of 87
, Term
A manufacturer is developing bioresorbable plug and delivery
devices sold together as a single kit. The bioresorbable plug is
placed in the femoral artery to close a puncture site after an
angioplasty procedure. The manufacturer has determined through
testing the plug is resorbed after 90 days. What is the device's
classification?
A. Class IIb device per Annex IX, Rule 6 as it is "wholly or mainly
absorbed"
B. Class IIa device per Annex IX, Rule 6 as the device is used for
transient use and is not used in the central
circulatory system
C. Class III device per Annex IX, Rule 8 as it is "wholly or mainly
absorbed"
D. Class III device per Annex IX, Rule 7 as it is "wholly or mainly
absorbed"
Give this one a try later!
A. Obtain Notified Body approval of C. Class III device per Annex
the technical documentation and IX, Rule 8 as it is "wholly or
the quality system mainly absorbed"
A. Notify the manufacturer and B. Confirm risk management file
request the label be changed to references information contained in
include Swedish. the R&D, mfging, and QA docs
Don't know?
5 of 87
ANSWERS SOLVED 100% CORRECT!!
1 of 87
Term
The number of times a recognized hazardous situation occurs when
a device is used as intended is higher than the manufacturer
expected. Which action should the manufacturer take?
A. Immediately recall the product
B. Continue to gather data to see if this trend continues
C. Revise labelling to inform user
D. Feed this information back to the risk management process
Give this one a try later!
, D. Feed this information back
A. Accounting for product labeling to the risk management
pre- and post-processing process
A. Device fails to comply with any A. CE marking under MDD
paragraph of the QSR 93/42/EEC is sufficient
Don't know?
2 of 87
Term
An article published in scientific journal based on experiences in
Korean hospital indicates there are problems with use of a mfger's
CE-marked device. Medical intervention was necessary to prevent
serious injury; however, it was determined FSCA is not necessary.
Whom should mfger inform of the situation?
A. CA
B. NB
C. EU Commission
D. No reporting is required
Give this one a try later!
D. No reporting is required B. Compatibility and safety
A. CE marking under MDD
A. Document control manager
93/42/EEC is sufficient
, Don't know?
3 of 87
Term
A US based manufacturer produces a Class I medical device with a
CE mark that is sold in Germany. The authorized representative is
located in the Netherlands. An identical medical device is sold
outside of the EU. An incident is reported in Japan and leads to an
FSCA. The US based manufacturer immediately identifies the
problem and makes a change to a mold to prevent future incidents.
Whom should the US based manufacturer inform of the situation?
A. Appropriate authorities outside the EU
B. CA in Germany
C. CA in Netherlands
D. NB
Give this one a try later!
D. Initiate the manufacturer's CAPA
C. CA in Netherlands
process
C. Market retrieval of product D. No reporting is required
Don't know?
4 of 87
, Term
A manufacturer is developing bioresorbable plug and delivery
devices sold together as a single kit. The bioresorbable plug is
placed in the femoral artery to close a puncture site after an
angioplasty procedure. The manufacturer has determined through
testing the plug is resorbed after 90 days. What is the device's
classification?
A. Class IIb device per Annex IX, Rule 6 as it is "wholly or mainly
absorbed"
B. Class IIa device per Annex IX, Rule 6 as the device is used for
transient use and is not used in the central
circulatory system
C. Class III device per Annex IX, Rule 8 as it is "wholly or mainly
absorbed"
D. Class III device per Annex IX, Rule 7 as it is "wholly or mainly
absorbed"
Give this one a try later!
A. Obtain Notified Body approval of C. Class III device per Annex
the technical documentation and IX, Rule 8 as it is "wholly or
the quality system mainly absorbed"
A. Notify the manufacturer and B. Confirm risk management file
request the label be changed to references information contained in
include Swedish. the R&D, mfging, and QA docs
Don't know?
5 of 87
