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Vigilance Reporting - Requirements for manufacturer Field Corrective Actions (FCAs)

fialor

Involved In Discussions
#1
Hi All, help please., thank you.
I am aware of the reporting criteria for FSCAs but are there any requirement for manufacturer Field Corrective Actions (FCAs) to be reported to NCAs as well?
A notified body for a client seems to think it is a requirement for the EU.
Thank you for any feedback!
 
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Jane_S

Starting to get Involved
#2
According to Article 92 (7):

"The reports on field safety corrective actions referred to in point (b) of Article 87(1) shall be automatically transmitted upon receipt via the electronic system referred to in paragraph 1 of this Article to the competent authorities of the following Member States:
(a) the Member States in which the field safety corrective action is being or is to be undertaken;
(b) the Member State in which the manufacturer has its registered place of business."

Basically, you have to report FSCA to your NCA and CAs of the Member States where affected products are distributed.
 

fialor

Involved In Discussions
#3
Jane_S, thank you.
I am aware of the FSCA reporting requirements.
My question was for FCAs (field corrective actions).
Thank you.
 

Jane_S

Starting to get Involved
#4
Jane_S, thank you.
I am aware of the FSCA reporting requirements.
My question was for FCAs (field corrective actions).
Thank you.

I am sorry, maybe I missed something, are we talking about the requirements of MDR? The only term for Field corrective action I can find in there is 'Field safety corrective action'. Are you referring to field safety notice?
 

chris1price

Trusted Information Resource
#6
Hi, I can't find the term Field Corrective Action in either 93/2/EC MDD or MEDDEV 2-12-1. Can you point to the appropriate clause?

Regarding Field Safety Corrective Actions (FSCA) Section 5.4.4.1 of the Meddev, does say:

"The MANUFACTURER should issue a notification (see below) to the Competent Authorities of all countries affected at the same time and also to the National Competent Authority responsible for the MANUFACTURER or AUTHORISED REPRESENTATIVE"

also

"MANUFACTURERs should also include a copy of the FIELD SAFETY NOTICE to the Competent Authorities along with the notification. This should be done before or at the same time as FSCA is being issued."
 
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