The Medical Devices Introductory Course 2020

FSCA

 The Report

• Complete the FSCA report for in MEDDEV 2.12-1 rev 8

– Complete as much of the form as possible but do not delay submission or implementation of FSCA to gather missing information

• FSCA must be reported to the CA in each of the countries where it is being conducted

– Before the action is implemented • Provide lead CA opportunity to comment (suggest 48hrs) but not at the expense of patient safety !!

• What about member states which are not affected by the FSCA ?

• What about your Notified Body ?

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FSCA  FSCA Strategy

• Must be co-ordinated !

• Agree upon and document

– timing, – notifications, – method of message delivery,

– reconciliation method and targets, – how to provide replacement product, – communication strategy – media, press, customers, regulators, investors …

• Marketing impact ? Positive or Negative ?

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