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Assess the worldwide regulatory impact of the changes

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Reference no: EM132826880

In order to transition in commercialized device from MDD to MDR in the EU, a medical device company need to update the IFU to include additional information regarding clinical benefits. Which Which action should the regulatory professional perform FIRST in this situation?

a. Assess the worldwide regulatory impact of the changes to the IFU to determine, if further reg. actions will be needed

b. Initiate regulatory, submission worldwide so all geographic can gain approval for the updated IFU prior to implementation

c. Recommend withdrawal from the EU market until IFU changes are implemented

d. Implement the changes immediately to ensure timely transition to MDR

Reference no: EM132826880

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