EU: Significant changes are being made to several standards your company
references in the Essential Requirements checklists you completed for the
company's products. As the regulatory manager, what should you tell
other managers and executives in the company about these changes?
A) You can review the changes during your next surveillance audit by your
Notified Body.
B) You need to review the changes and document the effect on your
quality system, demonstration of conformance and any necessary actions.
C) You need to obtain the new standards and keep them on file.
D) The changes do not impact the organisation, so no action is needed. - ✔✔B)
You need to review the changes and document the effect on your quality
system, demonstration of conformance and any necessary actions.
, Your Notified Body is classifying your device differently from you assessment.
After reviewing the classification rules, you are certain your classification is
correct; however, the Notified Body is not willing to reconsider. What is the
BEST strategy to resolve this situation?
A) Change Notified Body
B) Discuss with the Notified Body the reasons for your opinion
C) Ask the Notified Body to get an opinion from its Competent Authority
D) Sign the Declaration of Conformity and CE mark your device - ✔✔C) Ask
the Notified Body to get an opinion from its Competent Authority
Your company is planning to make a custom-made device for a customer. What
CE marking strategy is required to sell the device?
A) Declaration of Conformity and CE Mark are required to market the device
B) A CE Mark is not required, but a Declaration of Conformity is required and the
Member State may request a list of custom devices in its territory
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