RAPS EXAM NEWEST 2025-2026
COMPLETE QUESTIONS AND CORRECT
ANSWERS (VERIFIED ANSWERS)
|ALREADY GRADED A+
A clinical trial of a medical device can begin how many
days after notification is sent to the Competent Authority?
A. 30 days
B. 45 days
C. 60 days
D. As soon as Ethical Committee approval is received
Correct Answer C. 60 days
A US manufacturer CE marks its Class IIa medical device
and labels it in English, French, German, Italian and
Spanish. A French based distributor has a contract with
the company to distribute, market and supply the product
in the UK, France, Germany, Italy and Spain. A hospital in
Sweden calls the distributor requesting a regular supply of
the product. The distributor should:
A. Notify the manufacturer and request the label be
changed to include Swedish.
B. Supply the product as labelled since English is
understood in Sweden.
C. Not supply into Sweden until a local distributor is
appointed.
D. Translate the label into Swedish and ship the product.
Correct Answer A. Notify the manufacturer and request
the label be changed to include Swedish.
,A company is planning to launch its new List B (Annex II)
IVD. Which of the following actions should the regulatory
professional recommend to the company?
A. Obtain Notified Body approval of the technical
documentation and the quality system
B. CE mark the device using the "self-certification" route
C. Ensure that the Notified Body conducts batch release
and examination of the dossier design
D. Conduct performance evaluation in accordance with
common technical specifications Correct Answer A. Obtain
Notified Body approval of the technical documentation and
the quality system
Which of the following BEST demonstrates conformance
with the Essential Requirements for a Class IIa device?
A. Test lab results that are authorised by the state
Competent Authority
B. Testing conducted by the manufacturer showing
conformance to harmonised standards
C. It is not necessary to show conformance through
testing because application of standards is voluntary
D. Testing conducted by the manufacturer showing
conformance to international or national standards.
Correct Answer B. Testing conducted by the manufacturer
showing conformance to harmonised standards
A mfger of a permanently implanted active device is
seeking guidance on conformance to Essential
Requirements. What advice would you give?
A. Conformance to 90/385/EEC is needed
,B. Conformance to 93/42/EEC is needed
C. Conformance to 98/79/EC is needed
D. For active implantable devices, CE Mark is not required
Correct Answer A. Conformance to 90/385/EEC is
necessary
The internal audit area of a company is itself due for an
internal review and audit. The internal audit procedure was
written by an external regulatory/quality consultant. The
quality manager is responsible for setting the internal audit
schedule, ensuring audit documentation is complete and
that actions are taken. The BEST person to conduct this
audit is the:
A. Document control manager
B. Regulatory/quality consultant
C. Quality manager
D. Quality inspector who reports to the quality manager
Correct Answer A. Document control manager
The Declaration of Conformity supporting the CE marking
of a Class I device includes all EXCEPT:
A. The signature of the NB
B. Identification of directives to which declaration is issued
C. The manufacturer's name and address
D. Product Information (name, type or model number)
Correct Answer A. The signature of the NB
To maintain a valid CE Mark for devices under Annex II,
the mfger should:
, A. Collect all relevant new information, compile it and
submit it to NB at end of three-year period following CE
marking
B. Collect all relevant new information, compile it and
update technical files for audit and review by NB as
required during five-year period following CE marking
C. Collect all relevant new information and update
technical documentation at end of five-year period
D. Follow the newly published EN standard to update
technical documentation every three years Correct Answer
B. Collect all relevant new information, compile it and
update technical files for audit and review by NB as
required during five-year period following CE marking
Your company is planning to make a custom-made device
for a customer. What CE marking strategy is required to
sell the device?
A. DoC and CE Mark are required to market the device
B. A CE Mark is not required, but DoC is required and the
Member State may request a list of custom devices in its
territory
C. A DoC has been produced by the manufacturer
D. A CE Mark is required and then the CE-marked device
can move freely throughout Europe Correct Answer B. A
CE Mark is not required, but DoC is required and the
Member State may request a list of custom devices in its
territory
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
COMPLETE QUESTIONS AND CORRECT
ANSWERS (VERIFIED ANSWERS)
|ALREADY GRADED A+
A clinical trial of a medical device can begin how many
days after notification is sent to the Competent Authority?
A. 30 days
B. 45 days
C. 60 days
D. As soon as Ethical Committee approval is received
Correct Answer C. 60 days
A US manufacturer CE marks its Class IIa medical device
and labels it in English, French, German, Italian and
Spanish. A French based distributor has a contract with
the company to distribute, market and supply the product
in the UK, France, Germany, Italy and Spain. A hospital in
Sweden calls the distributor requesting a regular supply of
the product. The distributor should:
A. Notify the manufacturer and request the label be
changed to include Swedish.
B. Supply the product as labelled since English is
understood in Sweden.
C. Not supply into Sweden until a local distributor is
appointed.
D. Translate the label into Swedish and ship the product.
Correct Answer A. Notify the manufacturer and request
the label be changed to include Swedish.
,A company is planning to launch its new List B (Annex II)
IVD. Which of the following actions should the regulatory
professional recommend to the company?
A. Obtain Notified Body approval of the technical
documentation and the quality system
B. CE mark the device using the "self-certification" route
C. Ensure that the Notified Body conducts batch release
and examination of the dossier design
D. Conduct performance evaluation in accordance with
common technical specifications Correct Answer A. Obtain
Notified Body approval of the technical documentation and
the quality system
Which of the following BEST demonstrates conformance
with the Essential Requirements for a Class IIa device?
A. Test lab results that are authorised by the state
Competent Authority
B. Testing conducted by the manufacturer showing
conformance to harmonised standards
C. It is not necessary to show conformance through
testing because application of standards is voluntary
D. Testing conducted by the manufacturer showing
conformance to international or national standards.
Correct Answer B. Testing conducted by the manufacturer
showing conformance to harmonised standards
A mfger of a permanently implanted active device is
seeking guidance on conformance to Essential
Requirements. What advice would you give?
A. Conformance to 90/385/EEC is needed
,B. Conformance to 93/42/EEC is needed
C. Conformance to 98/79/EC is needed
D. For active implantable devices, CE Mark is not required
Correct Answer A. Conformance to 90/385/EEC is
necessary
The internal audit area of a company is itself due for an
internal review and audit. The internal audit procedure was
written by an external regulatory/quality consultant. The
quality manager is responsible for setting the internal audit
schedule, ensuring audit documentation is complete and
that actions are taken. The BEST person to conduct this
audit is the:
A. Document control manager
B. Regulatory/quality consultant
C. Quality manager
D. Quality inspector who reports to the quality manager
Correct Answer A. Document control manager
The Declaration of Conformity supporting the CE marking
of a Class I device includes all EXCEPT:
A. The signature of the NB
B. Identification of directives to which declaration is issued
C. The manufacturer's name and address
D. Product Information (name, type or model number)
Correct Answer A. The signature of the NB
To maintain a valid CE Mark for devices under Annex II,
the mfger should:
, A. Collect all relevant new information, compile it and
submit it to NB at end of three-year period following CE
marking
B. Collect all relevant new information, compile it and
update technical files for audit and review by NB as
required during five-year period following CE marking
C. Collect all relevant new information and update
technical documentation at end of five-year period
D. Follow the newly published EN standard to update
technical documentation every three years Correct Answer
B. Collect all relevant new information, compile it and
update technical files for audit and review by NB as
required during five-year period following CE marking
Your company is planning to make a custom-made device
for a customer. What CE marking strategy is required to
sell the device?
A. DoC and CE Mark are required to market the device
B. A CE Mark is not required, but DoC is required and the
Member State may request a list of custom devices in its
territory
C. A DoC has been produced by the manufacturer
D. A CE Mark is required and then the CE-marked device
can move freely throughout Europe Correct Answer B. A
CE Mark is not required, but DoC is required and the
Member State may request a list of custom devices in its
territory
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
