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Hello and thanks for your participation.
Queston is on vigilance reporting for medical device
have a 1st draft deision document whichjI will try to incorporate
I am looking for a decision tree or SOP that presents the same process of when and where to file incident (serious event reporting,
Reporting situation draft is pasted below.
This is not my strong suit. Any feedback is appreciated.
MDR and Incident Reporting Decision Situations
Based on Location of Occurrence:
SituationUSA01:
Adverse event occurs only in USA
Same or similar Device with feature/mechanism involved not sold anywhere else
Report to FDA using Form 3500A
SituationUSA02:
Adverse event occurs only in USA
Same or similar Device with feature/mechanism involved sold in EU
Report to FDA using Form 3500A
SituationUSA03:
Adverse event occurs only in USA
Same or similar Device with feature/mechanism involved sold in Canada
Report to FDA using Form 3500A
Report as required to Health Canada
SituationUSA04:
Adverse event occurs only in USA
Same or similar Device with feature/mechanism involved sold in Japan
Report to FDA using Form 3500A
Report to JAL
SituationUSA05:
Adverse event occurs only in USA
Same or similar Device with feature/mechanism involved sold in Canada
Same or similar Device with feature/mechanism involved sold in Japan
Report to FDA using Form 3500A
Report as required to Health Canada
Report to JAL
SituationUSA&EU 01:
Adverse events occurs in USA and EU
Same or similar Device with feature/mechanism involved sold in both Markets
Report through Authorized representative and determine all EU markets
Report to FDA using Form 3500A
SituationUSA&EU 02:
Adverse events occurs in USA and EU
Same or similar Device with feature/mechanism involved sold in both Markets
Same or similar Device with feature/mechanism involved sold in Canada
Report through Authorized representative and determine all EU markets
Report to FDA using Form 3500A
Report as required to Health Canada
SituationUSA&EU 03:
Adverse events occurs in USA and EU
Same or similar Device with feature/mechanism involved sold in both Markets
Same or similar Device with feature/mechanism involved sold in Japan
Report through Authorized representative and determine all EU markets
Report to FDA using Form 3500A
Report to JAL
SituationUSA&EU 04:
Adverse events occurs in USA and EU
Same or similar Device with feature/mechanism involved sold in both Markets
Same or similar Device with feature/mechanism involved sold in Canada
Same or similar Device with feature/mechanism involved sold in Japan
Report through Authorized representative and determine all EU markets
Report to FDA using Form 3500A
Report to JAL
SituationEU01:
Adverse event occurs only in EU
Same or similar Device with feature/mechanism involved sold in USA
Report through Authorized representative
Report to FDA using Form 3500A
SituationEU02:
Adverse event occurs only in EU
Same or similar Device with feature/mechanism involved sold in USA
Same or similar Device with feature/mechanism involved sold in other EU countries
Report through Authorized representative and determine all EU markets
Report to FDA using Form 3500A
SituationEU03:
Adverse event occurs only in EU
Same or similar Device with feature/mechanism involved sold in USA
Same or similar Device with feature/mechanism involved sold in other EU countries
Same or similar Device with feature/mechanism involved sold in Canada
Report through Authorized representative and determine all EU markets
Report to FDA using Form 3500A
Report as required to Health Canada
SituationEU04:
Adverse event occurs only in EU
Same or similar Device with feature/mechanism involved sold in other EU countries
Report through Authorized representative and determine all EU markets
SituationEU05:
Adverse event occurs only in single EU market/State
Report through Authorized representative
SituationCA01:
Adverse event occurs only in Canada
Same or similar Device with feature/mechanism involved sold in USA
Report as required to Health Canada
Report to FDA using Form 3500A
SituationCA02:
Adverse event occurs only in Canada
Same or similar Device with feature/mechanism involved sold in USA
Same or similar Device with feature/mechanism involved sold in EU
Report as required to Health Canada
Report as required to FDA using Form 3500A
Report through Authorized representative and determine all EU markets
SituationCA03:
Adverse event occurs only in Canada
Same or similar Device with feature/mechanism involved sold in USA
Same or similar Device with feature/mechanism involved sold in EU
Same or similar Device with feature/mechanism involved sold in Japan
Report as required to Health Canada
Report as required to FDA using Form 3500A
Report through Authorized representative and determine all EU markets
Report to JAL
Queston is on vigilance reporting for medical device
have a 1st draft deision document whichjI will try to incorporate
I am looking for a decision tree or SOP that presents the same process of when and where to file incident (serious event reporting,
Reporting situation draft is pasted below.
This is not my strong suit. Any feedback is appreciated.
MDR and Incident Reporting Decision Situations
Based on Location of Occurrence:
SituationUSA01:
Adverse event occurs only in USA
Same or similar Device with feature/mechanism involved not sold anywhere else
Report to FDA using Form 3500A
SituationUSA02:
Adverse event occurs only in USA
Same or similar Device with feature/mechanism involved sold in EU
Report to FDA using Form 3500A
SituationUSA03:
Adverse event occurs only in USA
Same or similar Device with feature/mechanism involved sold in Canada
Report to FDA using Form 3500A
Report as required to Health Canada
SituationUSA04:
Adverse event occurs only in USA
Same or similar Device with feature/mechanism involved sold in Japan
Report to FDA using Form 3500A
Report to JAL
SituationUSA05:
Adverse event occurs only in USA
Same or similar Device with feature/mechanism involved sold in Canada
Same or similar Device with feature/mechanism involved sold in Japan
Report to FDA using Form 3500A
Report as required to Health Canada
Report to JAL
SituationUSA&EU 01:
Adverse events occurs in USA and EU
Same or similar Device with feature/mechanism involved sold in both Markets
Report through Authorized representative and determine all EU markets
Report to FDA using Form 3500A
SituationUSA&EU 02:
Adverse events occurs in USA and EU
Same or similar Device with feature/mechanism involved sold in both Markets
Same or similar Device with feature/mechanism involved sold in Canada
Report through Authorized representative and determine all EU markets
Report to FDA using Form 3500A
Report as required to Health Canada
SituationUSA&EU 03:
Adverse events occurs in USA and EU
Same or similar Device with feature/mechanism involved sold in both Markets
Same or similar Device with feature/mechanism involved sold in Japan
Report through Authorized representative and determine all EU markets
Report to FDA using Form 3500A
Report to JAL
SituationUSA&EU 04:
Adverse events occurs in USA and EU
Same or similar Device with feature/mechanism involved sold in both Markets
Same or similar Device with feature/mechanism involved sold in Canada
Same or similar Device with feature/mechanism involved sold in Japan
Report through Authorized representative and determine all EU markets
Report to FDA using Form 3500A
Report to JAL
SituationEU01:
Adverse event occurs only in EU
Same or similar Device with feature/mechanism involved sold in USA
Report through Authorized representative
Report to FDA using Form 3500A
SituationEU02:
Adverse event occurs only in EU
Same or similar Device with feature/mechanism involved sold in USA
Same or similar Device with feature/mechanism involved sold in other EU countries
Report through Authorized representative and determine all EU markets
Report to FDA using Form 3500A
SituationEU03:
Adverse event occurs only in EU
Same or similar Device with feature/mechanism involved sold in USA
Same or similar Device with feature/mechanism involved sold in other EU countries
Same or similar Device with feature/mechanism involved sold in Canada
Report through Authorized representative and determine all EU markets
Report to FDA using Form 3500A
Report as required to Health Canada
SituationEU04:
Adverse event occurs only in EU
Same or similar Device with feature/mechanism involved sold in other EU countries
Report through Authorized representative and determine all EU markets
SituationEU05:
Adverse event occurs only in single EU market/State
Report through Authorized representative
SituationCA01:
Adverse event occurs only in Canada
Same or similar Device with feature/mechanism involved sold in USA
Report as required to Health Canada
Report to FDA using Form 3500A
SituationCA02:
Adverse event occurs only in Canada
Same or similar Device with feature/mechanism involved sold in USA
Same or similar Device with feature/mechanism involved sold in EU
Report as required to Health Canada
Report as required to FDA using Form 3500A
Report through Authorized representative and determine all EU markets
SituationCA03:
Adverse event occurs only in Canada
Same or similar Device with feature/mechanism involved sold in USA
Same or similar Device with feature/mechanism involved sold in EU
Same or similar Device with feature/mechanism involved sold in Japan
Report as required to Health Canada
Report as required to FDA using Form 3500A
Report through Authorized representative and determine all EU markets
Report to JAL