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!
 
Elsmar Forum Sponsor

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."
 
Thread starter Similar threads Forum Replies Date
W SOP for Vigilance reporting covering multiple requirements Document Control Systems, Procedures, Forms and Templates 3
S Help with EU Medical Device Vigilance Reporting Requirements EU Medical Device Regulations 0
D Vigilance Trend reporting requirements of Meddev 2.12/ver 7 in the EU Document Control Systems, Procedures, Forms and Templates 1
T EU Medical Device Vigilance Reporting Requirements EU Medical Device Regulations 3
arios Flowchart to explain the Medical Device Vigilance Reporting Process wanted EU Medical Device Regulations 4
B Medical Device Vigilance Reporting Multi Markets Other ISO and International Standards and European Regulations 2
bio_subbu MHRA - Draft guidance on specific device vigilance reporting EU Medical Device Regulations 0
Z MEDDEV 2.12-1 Rev 5 Reportability Decision Tree? Vigilance Reporting Procedure EU Medical Device Regulations 18
A Who is in charge of Vigilance reporting in your company? ISO 13485:2016 - Medical Device Quality Management Systems 1
A Medical Device Vigilance decision tree for Japan for class 2 devices. Japan Medical Device Regulations 1
L Global distributor vigilance responsibility Medical Device and FDA Regulations and Standards News 14
M Informational DSVG 04 – Breast Implants – Guidance on the vigilance system for CE-marked medical devices Medical Device and FDA Regulations and Standards News 0
M Informational EU – DSVG 03 – Cardiac Implantable Electronic Devices (CIED) – Guidance on the vigilance system for CE-marked medical devices Medical Device and FDA Regulations and Standards News 0
M Saudi Arabia (KSA) - Medical Device Vigilance according to 93/42/CEE Other Medical Device Regulations World-Wide 0
K Vigilance process flow chart EU Medical Device Regulations 1
dgrainger Informational Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev. 8 EU Medical Device Regulations 1
M Informational MHRA update – Medical devices: guidance for manufacturers on vigilance - June 2019 Medical Device and FDA Regulations and Standards News 0
J Medical Device Vigilance decision tree FORM - Please share yours EU Medical Device Regulations 14
M Definition Vigilance - What is the definition of "Vigilance"? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 5
S Understanding PMS (Post Market Surveillance) and PMCF (Vigilance and PMCF) Quality Manager and Management Related Issues 1
J Can I combine Recalls, Advisory notices, and Vigilance systems into one procedure? ISO 13485:2016 - Medical Device Quality Management Systems 2
A Japan Medical Devices Vigilance Regulations or Guidelines Japan Medical Device Regulations 4
S Revised MEDDEV 2.12-1 rev 8 Vigilance System - Released EU Medical Device Regulations 3
bio_subbu EU publishes revised guidance on Medical Devices Vigilance system MEDDEV 2.12-1 Rev7 EU Medical Device Regulations 8
K Vigilance, MDR, Recall, Complaint Procedures - Can this all be one single procedure ISO 13485:2016 - Medical Device Quality Management Systems 3
P Good Vigilance Practice (GVP) - Japan - English translation and explanation of Japan Medical Device Regulations 8
I Vigilance SOP that covers Australia, Taiwan, Japan or Brazil wanted Other Medical Device Regulations World-Wide 1
P Medical Device Vigilance - MDR or MDD? EU Medical Device Regulations 9
T Vigilance System MEDDEV 2009 changes - MEDDEV 2.12-1 rev 6 for Vigilance System EU Medical Device Regulations 1
V Evidence for Preventive Action & Early Warning Vigilance procedure Preventive Action and Continuous Improvement 4
D Vigilance - Public database of Vigilance reports (similar to FDA MAUDE database)? Other Medical Device and Orthopedic Related Topics 1
J Vigilance Report Required for Incidents Outside the EU? EU Medical Device Regulations 2
J EU Vigilance (updated MEDDEV rev.5) - Internal Forms EU Medical Device Regulations 12
E How to practically organize the 'Vigilance' function? ISO 13485:2016 - Medical Device Quality Management Systems 7
J Distributor Requirements - Vigilance and Traceability ISO 13485:2016 - Medical Device Quality Management Systems 7
R Medical Device Vigilance System Requirements - CE Mark Products EU Medical Device Regulations 4
D Official Government Regulatory Body Vigilance Contacts to use for China and for India ISO 13485:2016 - Medical Device Quality Management Systems 4
C Audit NonConformance - Evidence of Post Market Vigilance and Product Recall. ISO 13485:2016 - Medical Device Quality Management Systems 6
O Medical Device (MedDev) Vigilance Guidelines for Importers into the UE EU Medical Device Regulations 5
J Medical Devices Vigilance Procedure Example needed Document Control Systems, Procedures, Forms and Templates 12
U Regulatory Contacts in every country for Medical Device Vigilance purposes ISO 13485:2016 - Medical Device Quality Management Systems 3
O Vigilance System - Seeking example Procedure and Implementation Advice ISO 13485:2016 - Medical Device Quality Management Systems 4
G ISO 17025-2017 Management Review reporting items - Inputs ISO 17025 related Discussions 1
A Medical device Reporting : Good Faith Effort for Additional information Other US Medical Device Regulations 2
B FDA-Medical Device Reporting (MDR )procedure compliant with 21CFR section 803 US Food and Drug Administration (FDA) 0
F Risk for Quality Assurance Department in a Hospital - Hospital Incident Reporting ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Differences in post market safety reporting for Combination Product Applicants Medical Device and FDA Regulations and Standards News 1
F ISO 13485 8.2.3 Reporting to regulatory authorities: Question regarding a procedure for this clause. ISO 13485:2016 - Medical Device Quality Management Systems 4
L Adverse Event Reporting New Zealand Other Medical Device Regulations World-Wide 11
M Informational New Zealand – Changes to Medical Device Adverse Event Reporting process Medical Device and FDA Regulations and Standards News 0
Similar threads


















































Top Bottom