Whom should I send the FSCA (Field Safety Corrective Action) to?

A

Arnthor

#1
Dear all,

With regards to “MEDDEV 2.12/1 rev.6 Medical devices vigilance system” page 13, it stated:

"Incidents which occurred outside the EEA and Switzerland and led to a FIELD SAFETY CORRECTIVE ACTION relevant to the above-mentioned geographical areas must be reported as a FIELD SAFETY CORRECTIVE ACTION."

If I have a incident outside EEA and Switzerland which lead to a FSCA, who should I send the report to?

Best regards,

Arnthor
 
Elsmar Forum Sponsor

somashekar

Staff member
Super Moderator
#3
Dear all,

With regards to “MEDDEV 2.12/1 rev.6 Medical devices vigilance system” page 13, it stated:

"Incidents which occurred outside the EEA and Switzerland and led to a FIELD SAFETY CORRECTIVE ACTION relevant to the above-mentioned geographical areas must be reported as a FIELD SAFETY CORRECTIVE ACTION."

If I have a incident outside EEA and Switzerland which lead to a FSCA, who should I send the report to?

Best regards,

Arnthor
Hii Arnthor...
If you are outside of the EU, please make your EU authorized representative the interface between you and the Authorities / NB, and he could do the needful. Send him the FSCA.

For Incidents occurring outside the EEA and Switzerland and do not lead to a Field Safety corrective action (FSCA) relevant to these geographic areas do not need to be Reported. For incidents occurring outside the EEA and Switzerland and led to a field Safety corrective action relevant to the above-mentioned geographical areas, the field safety corrective action is shared to the authorized representative who interfaces and submits the same to the appropriate Competent Authority, and to the notified body. Customers are notified via Field Safety Notice (FSN)

The above is an extract from our procedure...
 
Last edited:
Thread starter Similar threads Forum Replies Date
SK13485 How does the eMDVR works? To Whom all should the MDV to be reported? EU Medical Device Regulations 6
P Nonconformance Request should go to whom? Nonconformance and Corrective Action 7
K When, whom, how to conduct hazard analysis of PRP?s, OPRP?s and CCP?s? Food Safety - ISO 22000, HACCP (21 CFR 120) 1
T To Whom it may concern... Imported Legacy Blogs 0
P Special characteristics symbols in work instruction - For whom? IATF 16949 - Automotive Quality Systems Standard 6
J What certification is required of whom? Multiple Locations and Testing Laboratory IATF 16949 - Automotive Quality Systems Standard 8
Crusader 5.5.3 Internal Communication - Communicating the effectiveness of the QMS - To Whom? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
I Company and Departmental Measurable Goals - How many, by whom... ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Wes Bucey Heroes or Villains? Whom do we prefer? Training - Internal, External, Online and Distance Learning 0
Gman2 Internal Audits - Who Can Audit Whom? Internal Auditing 7
J UDI-DI how should we interpret Device version or model to determine if a new UDI-DI is needed? EU Medical Device Regulations 0
Sidney Vianna Interesting Discussion Should ISO 9004 be changed from a guidance standard to a requirements standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
A Should I take an online course for a career in Occupational Health and Safety? Career and Occupation Discussions 2
J Should a Class 1 medical device with an option to measure body weight be considered Class 1m? EU Medical Device Regulations 0
K Should APQP/PPAP has its own section in a QM? Quality Management System (QMS) Manuals 1
S What should i choose for "testing procedure" characteristics? (N95) General Information Resources 0
P Should eIFU link per ISO 15223-1:2016 be added to labels out of scope of Reg 207/2012? EU Medical Device Regulations 1
S Which Sampling Plan(s) Should I Use? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
A Document release vs its related training. Which should come first? ISO 13485:2016 - Medical Device Quality Management Systems 18
S Which department should prepare the control plan? could you show me a standard regarding to this matter. FMEA and Control Plans 17
J Help settle a disagreement: Should external providers of preventive maintenance be on your ASL? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
N Master Samples - What should we be keeping? IATF 16949 - Automotive Quality Systems Standard 9
G Supplier delivered recent PPAP, should he deliver yearly layout inspection? IATF 16949 - Automotive Quality Systems Standard 4
John Broomfield Vote - Should ISO9004 Become a Requirements Standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
A Capability Study - in the beginning of your career what should you have known about the tool Quality Tools, Improvement and Analysis 11
J Should Loading and Unloading be Included in Cycle Times? Lean in Manufacturing and Service Industries 14
E Manufacturers should develop a testing device for covid19 Service Industry Specific Topics 0
T 510(k) submission - Which name should I use in the submission? Other US Medical Device Regulations 3
N ISO 19011:2018 - 5.4.2 "...audit program should engage in appropriate continual development..." Training - Internal, External, Online and Distance Learning 4
G Should I perform Gage R&R only at the beginning of a new project? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
DuncanGibbons Should the requirements FAA/EASA Part 21 be addressed within the QMS and AS9100D quality manual? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
M Should 510(k) Predicates be Actively Listed Devices? Other US Medical Device Regulations 12
B Why the Greek god Hephaestus should have done a design FMEA (DFMEA) on his giant robot APQP and PPAP 1
J On PFMEA for danger labels - Label always should be assigned severity 10 ? FMEA and Control Plans 3
H Who should be listed as the manufacturer/distributor on the box? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
M MDR, RED and LVD - Should our device comply with them? EU Medical Device Regulations 3
BeaBea How Many Processes should be created for each Department? Process Maps, Process Mapping and Turtle Diagrams 5
M Should volume of sales be factored into risk probability assessments? ISO 14971 - Medical Device Risk Management 33
MrTetris Should potential bugs be considered in software risk analysis? ISO 14971 - Medical Device Risk Management 5
S Should safety checks be included in the Control Plan? IATF 16949 - Automotive Quality Systems Standard 5
M Which incubation condition should be selected to recover both bacteria and fungus effectively Miscellaneous Environmental Standards and EMS Related Discussions 3
D Is there a specific location for PPE such as safety glass holders and glove dispensers should be mounted Occupational Health & Safety Management Standards 10
Robert Stanley Which Registrar Should I Choose for ISO 9001:2015 registration? Registrars and Notified Bodies 10
M Who should receive the bills from suppliers and vendors, account payable or procurement? Consultants and Consulting 4
V IATF 16949 8.4.1 Control of externally provided processes, products and services - Should the CB be on our Approved Supplier List? IATF 16949 - Automotive Quality Systems Standard 10
A We are ISO 13485:2016 should we be audited to ISO 14971 ISO 13485:2016 - Medical Device Quality Management Systems 16
E Received a Major finding during IATF Surveillance audit for loss of BIQS Level 3 (more than 6 SPPS in 6 months)...how should we address SYSTEMIC CA? IATF 16949 - Automotive Quality Systems Standard 11
J Organization merger. Should we keep two separate ISO 13485 certificates? ISO 13485:2016 - Medical Device Quality Management Systems 6
S Companies that maintain your machine should be in ASL? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
S Use of "Shall" versus "Should" in Procedures ISO 13485:2016 - Medical Device Quality Management Systems 26

Similar threads

Top Bottom