Regulatory Open Forum

I'm a bit confused. My company seems to use the terms "medical device reporting" and "vigilance requirements" interchangeably. Also which markets are using the term "adverse event" vs "incident"? Those seem to get thrown around interchangeably as well.

FDA: Medical Device Reporting / adverse event?
ROW: Vigilance Requirements / incident?

I've seen companies try to combine multiple jurisdictions' adverse event reporting requirements into a single universal set of criteria and terminology.  But that approach inevitably leads to under-reporting or over-reporting in certain jurisdictions.  Accordingly, my generally preferred approach is to keep the reporting thresholds and terminology for each jurisdiction separated from the others.  This is done by way of a separate SOP / WI for each jurisdiction.  A few examples are:

U.S. FDA: Here, FDA's Medical Device Reporting (MDR) regulations expect that all "complaints" and "adverse events", as officially defined by the FDA, be screened using FDA's MDR reportability criteria, which lead to still other officially-defined FDA terms.  In fact, FDA is so strongly committed to ensuring we use their terms, that you can find FDA Warning Letters citing failure to include FDA's specific terms in the firm's MDR reporting SOP.  The FDA's reporting criteria and regulations don't use language like, "incident", "serious incident", "vigilance", etc.  Moreover, FDA's reporting thresholds contain unique attributes not directly reflected in those of other jurisdictions.

European MDR/IVDR: Here, the requirement is to report "serious incidents".  The requirement is to screen any "incidents" to determine if they are "serious incidents", and then if so, a serious incident report must be made.  The term "vigilance" reporting has strong roots in the European jurisdiction.  The terms "incident" and "serious incident", along with related terms like "serious public health threat", have officially-defined meanings for Europe's Union; and those meanings don't always align with the terms / concepts / reporting thresholds used by other jurisdictions. To make things even trickier for Europe, they also officially define and use the reportability terms "adverse event" and "serious adverse event".  But when using those, it is only in regards to devices in clinical investigations.

Canada: Here, "incidents" that meet certain reporting criteria (see CMDR sections 59 -61 subparts) shall be reported.  While the CMDR don't officially define "incident", Health Canada does define this informally via guidance.  My experience with Health Canada inspections is that they will enforce the parameters of their guidance documents as if they were regulations; so be sure you incorporate those into your procedures.  On that note, your procedures might still refer to Canadian "Mandatory Problem Reporting".  That Canadian terminology was recently retired and replaced with the term "incident reporting".

UK and Australia: These have used terminology modeled after the retired EU MDD/IVDD approach which were precursors to the current EU MDR/IVDR requirements.

And so on.

Again, my strong recommendation is to forego trying to universalize these different terms.  Instead, we should have a dedicated reporting SOP/WI and decision tree form for each one. Hope this helps get you pointed in the right direction.

    

I'm a bit confused. My company seems to use the terms "medical device reporting" and "vigilance requirements" interchangeably. Also which markets are using the term "adverse event" vs "incident"? Those seem to get thrown around interchangeably as well.

FDA: Medical Device Reporting / adverse event?
ROW: Vigilance Requirements / incident?

Hi Stephanie

I partly use Kevin's type approach. I have created a master SOP on Safety Reporting and defined  terms in there and have a table an some high level text of each relevant countries' requirements.  The SOP gets ong, but it is an awareness SOP for Management.

Underneath that, for each country, as approval re gathered or nearing, and product will need written procedures for launch support, I create a RA  Department level procedure,  more on technical content of  work instruction on exactly how to report.

I've seen companies try to combine multiple jurisdictions' adverse event reporting requirements into a single universal set of criteria and terminology.  But that approach inevitably leads to under-reporting or over-reporting in certain jurisdictions.  Accordingly, my generally preferred approach is to keep the reporting thresholds and terminology for each jurisdiction separated from the others.  This is done by way of a separate SOP / WI for each jurisdiction.  A few examples are:

U.S. FDA: Here, FDA's Medical Device Reporting (MDR) regulations expect that all "complaints" and "adverse events", as officially defined by the FDA, be screened using FDA's MDR reportability criteria, which lead to still other officially-defined FDA terms.  In fact, FDA is so strongly committed to ensuring we use their terms, that you can find FDA Warning Letters citing failure to include FDA's specific terms in the firm's MDR reporting SOP.  The FDA's reporting criteria and regulations don't use language like, "incident", "serious incident", "vigilance", etc.  Moreover, FDA's reporting thresholds contain unique attributes not directly reflected in those of other jurisdictions.

European MDR/IVDR: Here, the requirement is to report "serious incidents".  The requirement is to screen any "incidents" to determine if they are "serious incidents", and then if so, a serious incident report must be made.  The term "vigilance" reporting has strong roots in the European jurisdiction.  The terms "incident" and "serious incident", along with related terms like "serious public health threat", have officially-defined meanings for Europe's Union; and those meanings don't always align with the terms / concepts / reporting thresholds used by other jurisdictions. To make things even trickier for Europe, they also officially define and use the reportability terms "adverse event" and "serious adverse event".  But when using those, it is only in regards to devices in clinical investigations.

Canada: Here, "incidents" that meet certain reporting criteria (see CMDR sections 59 -61 subparts) shall be reported.  While the CMDR don't officially define "incident", Health Canada does define this informally via guidance.  My experience with Health Canada inspections is that they will enforce the parameters of their guidance documents as if they were regulations; so be sure you incorporate those into your procedures.  On that note, your procedures might still refer to Canadian "Mandatory Problem Reporting".  That Canadian terminology was recently retired and replaced with the term "incident reporting".

UK and Australia: These have used terminology modeled after the retired EU MDD/IVDD approach which were precursors to the current EU MDR/IVDR requirements.

And so on.

Again, my strong recommendation is to forego trying to universalize these different terms.  Instead, we should have a dedicated reporting SOP/WI and decision tree form for each one. Hope this helps get you pointed in the right direction.

    

I'm a bit confused. My company seems to use the terms "medical device reporting" and "vigilance requirements" interchangeably. Also which markets are using the term "adverse event" vs "incident"? Those seem to get thrown around interchangeably as well.

FDA: Medical Device Reporting / adverse event?
ROW: Vigilance Requirements / incident?

I've seen companies try to combine multiple jurisdictions' adverse event reporting requirements into a single universal set of criteria and terminology.  But that approach inevitably leads to under-reporting or over-reporting in certain jurisdictions.  Accordingly, my generally preferred approach is to keep the reporting thresholds and terminology for each jurisdiction separated from the others.  This is done by way of a separate SOP / WI for each jurisdiction.  A few examples are:

U.S. FDA: Here, FDA's Medical Device Reporting (MDR) regulations expect that all "complaints" and "adverse events", as officially defined by the FDA, be screened using FDA's MDR reportability criteria, which lead to still other officially-defined FDA terms.  In fact, FDA is so strongly committed to ensuring we use their terms, that you can find FDA Warning Letters citing failure to include FDA's specific terms in the firm's MDR reporting SOP.  The FDA's reporting criteria and regulations don't use language like, "incident", "serious incident", "vigilance", etc.  Moreover, FDA's reporting thresholds contain unique attributes not directly reflected in those of other jurisdictions.

European MDR/IVDR: Here, the requirement is to report "serious incidents".  The requirement is to screen any "incidents" to determine if they are "serious incidents", and then if so, a serious incident report must be made.  The term "vigilance" reporting has strong roots in the European jurisdiction.  The terms "incident" and "serious incident", along with related terms like "serious public health threat", have officially-defined meanings for Europe's Union; and those meanings don't always align with the terms / concepts / reporting thresholds used by other jurisdictions. To make things even trickier for Europe, they also officially define and use the reportability terms "adverse event" and "serious adverse event".  But when using those, it is only in regards to devices in clinical investigations.

Canada: Here, "incidents" that meet certain reporting criteria (see CMDR sections 59 -61 subparts) shall be reported.  While the CMDR don't officially define "incident", Health Canada does define this informally via guidance.  My experience with Health Canada inspections is that they will enforce the parameters of their guidance documents as if they were regulations; so be sure you incorporate those into your procedures.  On that note, your procedures might still refer to Canadian "Mandatory Problem Reporting".  That Canadian terminology was recently retired and replaced with the term "incident reporting".

UK and Australia: These have used terminology modeled after the retired EU MDD/IVDD approach which were precursors to the current EU MDR/IVDR requirements.

And so on.

Again, my strong recommendation is to forego trying to universalize these different terms.  Instead, we should have a dedicated reporting SOP/WI and decision tree form for each one. Hope this helps get you pointed in the right direction.

    

I'm a bit confused. My company seems to use the terms "medical device reporting" and "vigilance requirements" interchangeably. Also which markets are using the term "adverse event" vs "incident"? Those seem to get thrown around interchangeably as well.

FDA: Medical Device Reporting / adverse event?
ROW: Vigilance Requirements / incident?

To add some more complications, at least FDA, if not other jurisdictions, expects you to report to their MDR system events that meet their definitions that occur on products that are distributed in US, NO MATTER WHERE THE EVENT OCCURS. So theoretically yo could have an event occur in Europe that has to be reported in US because the product was also distributed in the US. 

I've seen companies try to combine multiple jurisdictions' adverse event reporting requirements into a single universal set of criteria and terminology.  But that approach inevitably leads to under-reporting or over-reporting in certain jurisdictions.  Accordingly, my generally preferred approach is to keep the reporting thresholds and terminology for each jurisdiction separated from the others.  This is done by way of a separate SOP / WI for each jurisdiction.  A few examples are:

U.S. FDA: Here, FDA's Medical Device Reporting (MDR) regulations expect that all "complaints" and "adverse events", as officially defined by the FDA, be screened using FDA's MDR reportability criteria, which lead to still other officially-defined FDA terms.  In fact, FDA is so strongly committed to ensuring we use their terms, that you can find FDA Warning Letters citing failure to include FDA's specific terms in the firm's MDR reporting SOP.  The FDA's reporting criteria and regulations don't use language like, "incident", "serious incident", "vigilance", etc.  Moreover, FDA's reporting thresholds contain unique attributes not directly reflected in those of other jurisdictions.

European MDR/IVDR: Here, the requirement is to report "serious incidents".  The requirement is to screen any "incidents" to determine if they are "serious incidents", and then if so, a serious incident report must be made.  The term "vigilance" reporting has strong roots in the European jurisdiction.  The terms "incident" and "serious incident", along with related terms like "serious public health threat", have officially-defined meanings for Europe's Union; and those meanings don't always align with the terms / concepts / reporting thresholds used by other jurisdictions. To make things even trickier for Europe, they also officially define and use the reportability terms "adverse event" and "serious adverse event".  But when using those, it is only in regards to devices in clinical investigations.

Canada: Here, "incidents" that meet certain reporting criteria (see CMDR sections 59 -61 subparts) shall be reported.  While the CMDR don't officially define "incident", Health Canada does define this informally via guidance.  My experience with Health Canada inspections is that they will enforce the parameters of their guidance documents as if they were regulations; so be sure you incorporate those into your procedures.  On that note, your procedures might still refer to Canadian "Mandatory Problem Reporting".  That Canadian terminology was recently retired and replaced with the term "incident reporting".

UK and Australia: These have used terminology modeled after the retired EU MDD/IVDD approach which were precursors to the current EU MDR/IVDR requirements.

And so on.

Again, my strong recommendation is to forego trying to universalize these different terms.  Instead, we should have a dedicated reporting SOP/WI and decision tree form for each one. Hope this helps get you pointed in the right direction.

    

I'm a bit confused. My company seems to use the terms "medical device reporting" and "vigilance requirements" interchangeably. Also which markets are using the term "adverse event" vs "incident"? Those seem to get thrown around interchangeably as well.

FDA: Medical Device Reporting / adverse event?
ROW: Vigilance Requirements / incident?

I've seen companies try to combine multiple jurisdictions' adverse event reporting requirements into a single universal set of criteria and terminology.  But that approach inevitably leads to under-reporting or over-reporting in certain jurisdictions.  Accordingly, my generally preferred approach is to keep the reporting thresholds and terminology for each jurisdiction separated from the others.  This is done by way of a separate SOP / WI for each jurisdiction.  A few examples are:

U.S. FDA: Here, FDA's Medical Device Reporting (MDR) regulations expect that all "complaints" and "adverse events", as officially defined by the FDA, be screened using FDA's MDR reportability criteria, which lead to still other officially-defined FDA terms.  In fact, FDA is so strongly committed to ensuring we use their terms, that you can find FDA Warning Letters citing failure to include FDA's specific terms in the firm's MDR reporting SOP.  The FDA's reporting criteria and regulations don't use language like, "incident", "serious incident", "vigilance", etc.  Moreover, FDA's reporting thresholds contain unique attributes not directly reflected in those of other jurisdictions.

European MDR/IVDR: Here, the requirement is to report "serious incidents".  The requirement is to screen any "incidents" to determine if they are "serious incidents", and then if so, a serious incident report must be made.  The term "vigilance" reporting has strong roots in the European jurisdiction.  The terms "incident" and "serious incident", along with related terms like "serious public health threat", have officially-defined meanings for Europe's Union; and those meanings don't always align with the terms / concepts / reporting thresholds used by other jurisdictions. To make things even trickier for Europe, they also officially define and use the reportability terms "adverse event" and "serious adverse event".  But when using those, it is only in regards to devices in clinical investigations.

Canada: Here, "incidents" that meet certain reporting criteria (see CMDR sections 59 -61 subparts) shall be reported.  While the CMDR don't officially define "incident", Health Canada does define this informally via guidance.  My experience with Health Canada inspections is that they will enforce the parameters of their guidance documents as if they were regulations; so be sure you incorporate those into your procedures.  On that note, your procedures might still refer to Canadian "Mandatory Problem Reporting".  That Canadian terminology was recently retired and replaced with the term "incident reporting".

UK and Australia: These have used terminology modeled after the retired EU MDD/IVDD approach which were precursors to the current EU MDR/IVDR requirements.

And so on.

Again, my strong recommendation is to forego trying to universalize these different terms.  Instead, we should have a dedicated reporting SOP/WI and decision tree form for each one. Hope this helps get you pointed in the right direction.

    

I'm a bit confused. My company seems to use the terms "medical device reporting" and "vigilance requirements" interchangeably. Also which markets are using the term "adverse event" vs "incident"? Those seem to get thrown around interchangeably as well.

FDA: Medical Device Reporting / adverse event?
ROW: Vigilance Requirements / incident?

I'm a bit confused. My company seems to use the terms "medical device reporting" and "vigilance requirements" interchangeably. Also which markets are using the term "adverse event" vs "incident"? Those seem to get thrown around interchangeably as well.

FDA: Medical Device Reporting / adverse event?
ROW: Vigilance Requirements / incident?

I'm a bit confused. My company seems to use the terms "medical device reporting" and "vigilance requirements" interchangeably. Also which markets are using the term "adverse event" vs "incident"? Those seem to get thrown around interchangeably as well.

FDA: Medical Device Reporting / adverse event?
ROW: Vigilance Requirements / incident?

I'm a bit confused. My company seems to use the terms "medical device reporting" and "vigilance requirements" interchangeably. Also which markets are using the term "adverse event" vs "incident"? Those seem to get thrown around interchangeably as well.

FDA: Medical Device Reporting / adverse event?
ROW: Vigilance Requirements / incident?