The Medical Devices Introductory Course 2020

FSCA WHAT IS FSCA?

Field Safety Corrective Action

An action taken by a manufacturer to reduce the risk of death or serious deterioration in the state of health of a user, patient or other person associated with devices which are already in the market.

This may include:-

• Providing users with new IFU’ s

• Requesting users to return product

• Requesting users to destroy product

• Requesting users to modify product

• And much more…

The Organisation for Professionals in Regulatory Affairs

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FSCA

• 2017/745 Article 9, section 12

“Manufacturers who consider or have reason to believe that a device which they have placed on the market or put into service is not in conformity with this regulation shall immediately take the necessary corrective action to bring that device into conformity, to withdraw it or to recall it, as appropriate. They shall inform the distributors of the device in question and, where applicable, the EU AR and importers, accordingly. Where the device presents a serious risk manufacturers shall immediately inform the CA’s of the member states in which they made the device available and where applicable the NB that issued the certificate for the device in accordance with Article 56, in particular of the noncompliance and of any corrective action taken”

The Organisation for Professionals in Regulatory Affairs