Regulatory Open Forum

RAPS Expert,

Unfortunately, we got a complaint from one of our distributor in UK that end user injured himself because one of the component is broken during use.
Due to this issue, patient got minor cut and went to hospital for treatment. This is 1st incident specifically related to this problem since we started business (19 years).
We are EU MDR complaint but class I with DOC, FDA complaint, HC complaint, but again class I. 

What are the requirements of reporting to UK health authority and timeline?
Do I need to report EU competent authority as we are sending products as a CE marked in UK?
Do I need to report HC and US-FDA since we are selling same devices to these countries?

We are still collecting information from our distributor such as SRN so didn't log the customer complaint yet?
Also, why incident happened like is it manufacturer fault or user fault? When our time will start for vigilance reporting?

Just in case, if it's user fault, do I still need to report incident, etc. 

Thanks in advance for your expert opinion?

Hi Anon

First question - which jurisdiction is the manufacturer located in? That makes a difference for the reporting requirements.

There are some nuances, but generally the reporting timeline begins the day someone at your company found out there was an incident. And generally for reporting purposes it doesn't matter if it was anyone's fault.

You can read UK reporting rules here: https://www.gov.uk/government/collections/medical-devices-guidance-for-manufacturers-on-vigilance

It sounds like your company doesn't have an SOP explaining how to do the required vigilance activities, so you will want to address that gap, too.

RAPS Expert,

Unfortunately, we got a complaint from one of our distributor in UK that end user injured himself because one of the component is broken during use.
Due to this issue, patient got minor cut and went to hospital for treatment. This is 1st incident specifically related to this problem since we started business (19 years).
We are EU MDR complaint but class I with DOC, FDA complaint, HC complaint, but again class I. 

What are the requirements of reporting to UK health authority and timeline?
Do I need to report EU competent authority as we are sending products as a CE marked in UK?
Do I need to report HC and US-FDA since we are selling same devices to these countries?

We are still collecting information from our distributor such as SRN so didn't log the customer complaint yet?
Also, why incident happened like is it manufacturer fault or user fault? When our time will start for vigilance reporting?

Just in case, if it's user fault, do I still need to report incident, etc. 

Thanks in advance for your expert opinion?

Dear Anne,

Thanks for sharing useful link. 
As per instructions from MHRA, we created account but not sure about timeline 

unanticipated serious deterioration = do you know definition?
We found, end user got minor cuts only. Means, we have a timeline of 30 days. 

We are Canadian based manufacturer and have UK-RP. Do we need to report them as well or just upload information in MORE as MIR.

This is 1st minor incident since we started business (almost 20 years ago). 
Just in case, if we are not changing anything especially in service devices, I don't think so we need FSN and FSCA.
Please correct me if I'm wrong

Timescale for reporting an adverse incident to the MHRA

The manufacturer should notify the MHRA immediately upon becoming aware that one of its devices may have caused or contributed to an event meeting the above criteria.

The maximum permitted time between the manufacturer first becoming aware of the incident and notifying the MHRA are given below:

• Serious public health threat: No later than 2 calendar days after the manufacturer becomes aware
• Death or unanticipated serious deterioration in state of health: No later than 10 calendar days after the manufacturer becomes aware
• Others: No later than 30 calendar days after the manufacturer became aware

If after becoming aware of a potentially reportable incident it is unclear whether the event meets the reporting criteria above, the manufacturer must submit a report within the relevant timeframe.

Hi Anon

First question - which jurisdiction is the manufacturer located in? That makes a difference for the reporting requirements.

There are some nuances, but generally the reporting timeline begins the day someone at your company found out there was an incident. And generally for reporting purposes it doesn't matter if it was anyone's fault.

You can read UK reporting rules here: https://www.gov.uk/government/collections/medical-devices-guidance-for-manufacturers-on-vigilance

It sounds like your company doesn't have an SOP explaining how to do the required vigilance activities, so you will want to address that gap, too.

RAPS Expert,

Unfortunately, we got a complaint from one of our distributor in UK that end user injured himself because one of the component is broken during use.
Due to this issue, patient got minor cut and went to hospital for treatment. This is 1st incident specifically related to this problem since we started business (19 years).
We are EU MDR complaint but class I with DOC, FDA complaint, HC complaint, but again class I. 

What are the requirements of reporting to UK health authority and timeline?
Do I need to report EU competent authority as we are sending products as a CE marked in UK?
Do I need to report HC and US-FDA since we are selling same devices to these countries?

We are still collecting information from our distributor such as SRN so didn't log the customer complaint yet?
Also, why incident happened like is it manufacturer fault or user fault? When our time will start for vigilance reporting?

Just in case, if it's user fault, do I still need to report incident, etc. 

Thanks in advance for your expert opinion?

Dear Anne,

Thanks for sharing useful link. 
As per instructions from MHRA, we created account but not sure about timeline 

unanticipated serious deterioration = do you know definition?
We found, end user got minor cuts only. Means, we have a timeline of 30 days. 

We are Canadian based manufacturer and have UK-RP. Do we need to report them as well or just upload information in MORE as MIR.

This is 1st minor incident since we started business (almost 20 years ago). 
Just in case, if we are not changing anything especially in service devices, I don't think so we need FSN and FSCA.
Please correct me if I'm wrong

Timescale for reporting an adverse incident to the MHRA

The manufacturer should notify the MHRA immediately upon becoming aware that one of its devices may have caused or contributed to an event meeting the above criteria.

The maximum permitted time between the manufacturer first becoming aware of the incident and notifying the MHRA are given below:

• Serious public health threat: No later than 2 calendar days after the manufacturer becomes aware
• Death or unanticipated serious deterioration in state of health: No later than 10 calendar days after the manufacturer becomes aware
• Others: No later than 30 calendar days after the manufacturer became aware

If after becoming aware of a potentially reportable incident it is unclear whether the event meets the reporting criteria above, the manufacturer must submit a report within the relevant timeframe.

Hi Anon

First question - which jurisdiction is the manufacturer located in? That makes a difference for the reporting requirements.

There are some nuances, but generally the reporting timeline begins the day someone at your company found out there was an incident. And generally for reporting purposes it doesn't matter if it was anyone's fault.

You can read UK reporting rules here: https://www.gov.uk/government/collections/medical-devices-guidance-for-manufacturers-on-vigilance

It sounds like your company doesn't have an SOP explaining how to do the required vigilance activities, so you will want to address that gap, too.

RAPS Expert,

Unfortunately, we got a complaint from one of our distributor in UK that end user injured himself because one of the component is broken during use.
Due to this issue, patient got minor cut and went to hospital for treatment. This is 1st incident specifically related to this problem since we started business (19 years).
We are EU MDR complaint but class I with DOC, FDA complaint, HC complaint, but again class I. 

What are the requirements of reporting to UK health authority and timeline?
Do I need to report EU competent authority as we are sending products as a CE marked in UK?
Do I need to report HC and US-FDA since we are selling same devices to these countries?

We are still collecting information from our distributor such as SRN so didn't log the customer complaint yet?
Also, why incident happened like is it manufacturer fault or user fault? When our time will start for vigilance reporting?

Just in case, if it's user fault, do I still need to report incident, etc. 

Thanks in advance for your expert opinion?

Canada reporting guide:  https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/incident-reporting-medical-devices-guidance-2021.html

US reporting guide:  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-reporting-manufacturers

Dear Anne,

Thanks for sharing useful link. 
As per instructions from MHRA, we created account but not sure about timeline 

unanticipated serious deterioration = do you know definition?
We found, end user got minor cuts only. Means, we have a timeline of 30 days. 

We are Canadian based manufacturer and have UK-RP. Do we need to report them as well or just upload information in MORE as MIR.

This is 1st minor incident since we started business (almost 20 years ago). 
Just in case, if we are not changing anything especially in service devices, I don't think so we need FSN and FSCA.
Please correct me if I'm wrong

Timescale for reporting an adverse incident to the MHRA

The manufacturer should notify the MHRA immediately upon becoming aware that one of its devices may have caused or contributed to an event meeting the above criteria.

The maximum permitted time between the manufacturer first becoming aware of the incident and notifying the MHRA are given below:

• Serious public health threat: No later than 2 calendar days after the manufacturer becomes aware
• Death or unanticipated serious deterioration in state of health: No later than 10 calendar days after the manufacturer becomes aware
• Others: No later than 30 calendar days after the manufacturer became aware

If after becoming aware of a potentially reportable incident it is unclear whether the event meets the reporting criteria above, the manufacturer must submit a report within the relevant timeframe.

Hi Anon

First question - which jurisdiction is the manufacturer located in? That makes a difference for the reporting requirements.

There are some nuances, but generally the reporting timeline begins the day someone at your company found out there was an incident. And generally for reporting purposes it doesn't matter if it was anyone's fault.

You can read UK reporting rules here: https://www.gov.uk/government/collections/medical-devices-guidance-for-manufacturers-on-vigilance

It sounds like your company doesn't have an SOP explaining how to do the required vigilance activities, so you will want to address that gap, too.

RAPS Expert,

Unfortunately, we got a complaint from one of our distributor in UK that end user injured himself because one of the component is broken during use.
Due to this issue, patient got minor cut and went to hospital for treatment. This is 1st incident specifically related to this problem since we started business (19 years).
We are EU MDR complaint but class I with DOC, FDA complaint, HC complaint, but again class I. 

What are the requirements of reporting to UK health authority and timeline?
Do I need to report EU competent authority as we are sending products as a CE marked in UK?
Do I need to report HC and US-FDA since we are selling same devices to these countries?

We are still collecting information from our distributor such as SRN so didn't log the customer complaint yet?
Also, why incident happened like is it manufacturer fault or user fault? When our time will start for vigilance reporting?

Just in case, if it's user fault, do I still need to report incident, etc. 

Thanks in advance for your expert opinion?

RAPS Expert,

Unfortunately, we got a complaint from one of our distributor in UK that end user injured himself because one of the component is broken during use.
Due to this issue, patient got minor cut and went to hospital for treatment. This is 1st incident specifically related to this problem since we started business (19 years).
We are EU MDR complaint but class I with DOC, FDA complaint, HC complaint, but again class I. 

What are the requirements of reporting to UK health authority and timeline?
Do I need to report EU competent authority as we are sending products as a CE marked in UK?
Do I need to report HC and US-FDA since we are selling same devices to these countries?

We are still collecting information from our distributor such as SRN so didn't log the customer complaint yet?
Also, why incident happened like is it manufacturer fault or user fault? When our time will start for vigilance reporting?

Just in case, if it's user fault, do I still need to report incident, etc. 

Thanks in advance for your expert opinion?

RAPS Expert,

Unfortunately, we got a complaint from one of our distributor in UK that end user injured himself because one of the component is broken during use.
Due to this issue, patient got minor cut and went to hospital for treatment. This is 1st incident specifically related to this problem since we started business (19 years).
We are EU MDR complaint but class I with DOC, FDA complaint, HC complaint, but again class I. 

What are the requirements of reporting to UK health authority and timeline?
Do I need to report EU competent authority as we are sending products as a CE marked in UK?
Do I need to report HC and US-FDA since we are selling same devices to these countries?

We are still collecting information from our distributor such as SRN so didn't log the customer complaint yet?
Also, why incident happened like is it manufacturer fault or user fault? When our time will start for vigilance reporting?

Just in case, if it's user fault, do I still need to report incident, etc. 

Thanks in advance for your expert opinion?

We will need to know more organic details in order to give definitive direction for your particular case. And you need to be sure you have comprehensive and properly-written adverse event reporting procedures in place for all affected jurisdictions. But here are some rules of thumb in response to some basic questions:

Question: For a device placed on the market in the UK pursuant to a compliant EU MDR class I self-declaration conformity assessment, must a vigilance report be submitted to the UK's MHRA if there was a "minor cut" that happened in the UK where the patient went to the hospital for treatment?

Answer (Great Britain): If an event actually did occur (see MEDDEV 2 12-1 rev. 8), and if the manufacturer's device is suspected of being a contributory cause of the event, and if the event led to or might have led to (i.e., if it occurred again, it might lead to) a "minor cut" that was life-threatening or a permanent impairment of a body function or a permanent damage to a body structure or necessitated medical (e.g., hospital) or surgical intervention to prevent aforesaid consequences, then the "minor cut" is reportable to the MHRA. Unqualified persons should not be making these medical interpretations about the true clinical/medical nature and extent of the "minor cut"; instead, a person qualified to make such medical judgments is needed.

Note that these criteria are neither contingent on, nor in any way affected by, previously having a flawless 19-year track record.

Answer (Northern Ireland): Apply the EU MDR's serious incident reporting criteria instead, but then, if met, report to the MHRA nonetheless.

Question: What are the requirements of reporting to UK health authority and timeline?

Answer (Great Britain):(summary excluding statement of important details that must in addition be considered): Serious public health threat (see official definition): Immediately but not later than 2 calendar days after awareness by the manufacturer. Death or unanticipated serious deterioration in state of health (see official definition): Immediately but not later than 10 calendar days after date of awareness. Others: Immediately but not later than 30 calendar days after date of awareness.

Answer (Northern Ireland): See the EU MDR's Article 87(2) through 87(7) timelines.

Question: If the aforesaid event is reportable to the MHRA, is it also reportable to a European Competent Authority(s)?

Answer: If the UK incident led to FSCA of devices that were also placed on the market in Europe's Union, then an FSCA must also be initiated and reported with respect to the affected European Competent Authority(s).

Question: If the aforesaid event is reportable to the MHRA, is it also reportable to Health Canada?

Answer: Yes, if an FSCA has been initiated with the MHRA and the issue is relevant for devices authorized for sale in Canada and there is no prior Canadian Incident Report already submitted for a prior occurrence of this event that has the same root cause and the latest UK occurrence resulted in another corrective action separate from the first.

Question: If the aforesaid event is reportable to the MHRA, is it also reportable to the U.S. FDA?

Answer: If the subject device is legally marketed in the U.S. (e.g., is the subject of a valid medical device listing among possible other U.S. market authorization attributes) and if the nature and details of the MHRA event meet the U.S. FDA's Medical Device Reporting (MDR) criteria, then a corresponding MDR(s) must be submitted to the FDA within its respective timelines. See 21 CFR Part 803.

Question: If the event which meets the reporting criteria was caused by user error or use error, is the manufacturer required to report?

Answer: Because human factors and usability are expected to be considered when designing a device, use errors/misuse are generally considered to be device nonconformities for which the manufacturer is responsible, not user nonconformities. Yet the MEDDEV generally establishes that use error should be reported if it led to death or serious deterioration in state of health, but not reportable if not unless its trending shows a potential for death or serious deterioration in state of health or public health threat or if a corresponding FSCA was initiated to prevent these outcomes. The U.S. FDA does not give these liberties and generally requires reportable events to be reported regardless of whether, and especially if, it was attributed to user error. FDA has literally said that misuse is a device nonconformity. Health Canada's approach to reporting of use errors is somewhat of a hybrid of Europe's and the U.S.'s (see GUI-0059).

RAPS Expert,

Unfortunately, we got a complaint from one of our distributor in UK that end user injured himself because one of the component is broken during use.
Due to this issue, patient got minor cut and went to hospital for treatment. This is 1st incident specifically related to this problem since we started business (19 years).
We are EU MDR complaint but class I with DOC, FDA complaint, HC complaint, but again class I. 

What are the requirements of reporting to UK health authority and timeline?
Do I need to report EU competent authority as we are sending products as a CE marked in UK?
Do I need to report HC and US-FDA since we are selling same devices to these countries?

We are still collecting information from our distributor such as SRN so didn't log the customer complaint yet?
Also, why incident happened like is it manufacturer fault or user fault? When our time will start for vigilance reporting?

Just in case, if it's user fault, do I still need to report incident, etc. 

Thanks in advance for your expert opinion?

Thanks @Kevin Randall for super detailed response. 

We did some initial investigations with limited information as end user is not very responsive and not providing enough information.
Can we complete investigation and finalize report with very limited info. They just informed, this part is broken and got cuts. Not sure, How we can do complete investigation with limited info?

We're not initiating any FSN / FSCA based on investigation so we don't need to report EU MDR Competent Authority and Health Canada.

Do you have reference links?

Also, I checked FDA requirements for foreign Manufacturer and confirmed we don't need to report FDA as minor cuts incidents have not contributed a death or serious injury.  

We will need to know more organic details in order to give definitive direction for your particular case. And you need to be sure you have comprehensive and properly-written adverse event reporting procedures in place for all affected jurisdictions. But here are some rules of thumb in response to some basic questions:

Question: For a device placed on the market in the UK pursuant to a compliant EU MDR class I self-declaration conformity assessment, must a vigilance report be submitted to the UK's MHRA if there was a "minor cut" that happened in the UK where the patient went to the hospital for treatment?

Answer (Great Britain): If an event actually did occur (see MEDDEV 2 12-1 rev. 8), and if the manufacturer's device is suspected of being a contributory cause of the event, and if the event led to or might have led to (i.e., if it occurred again, it might lead to) a "minor cut" that was life-threatening or a permanent impairment of a body function or a permanent damage to a body structure or necessitated medical (e.g., hospital) or surgical intervention to prevent aforesaid consequences, then the "minor cut" is reportable to the MHRA. Unqualified persons should not be making these medical interpretations about the true clinical/medical nature and extent of the "minor cut"; instead, a person qualified to make such medical judgments is needed.

Note that these criteria are neither contingent on, nor in any way affected by, previously having a flawless 19-year track record.

Answer (Northern Ireland): Apply the EU MDR's serious incident reporting criteria instead, but then, if met, report to the MHRA nonetheless.

Question: What are the requirements of reporting to UK health authority and timeline?

Answer (Great Britain):(summary excluding statement of important details that must in addition be considered): Serious public health threat (see official definition): Immediately but not later than 2 calendar days after awareness by the manufacturer. Death or unanticipated serious deterioration in state of health (see official definition): Immediately but not later than 10 calendar days after date of awareness. Others: Immediately but not later than 30 calendar days after date of awareness.

Answer (Northern Ireland): See the EU MDR's Article 87(2) through 87(7) timelines.

Question: If the aforesaid event is reportable to the MHRA, is it also reportable to a European Competent Authority(s)?

Answer: If the UK incident led to FSCA of devices that were also placed on the market in Europe's Union, then an FSCA must also be initiated and reported with respect to the affected European Competent Authority(s).

Question: If the aforesaid event is reportable to the MHRA, is it also reportable to Health Canada?

Answer: Yes, if an FSCA has been initiated with the MHRA and the issue is relevant for devices authorized for sale in Canada and there is no prior Canadian Incident Report already submitted for a prior occurrence of this event that has the same root cause and the latest UK occurrence resulted in another corrective action separate from the first.

Question: If the aforesaid event is reportable to the MHRA, is it also reportable to the U.S. FDA?

Answer: If the subject device is legally marketed in the U.S. (e.g., is the subject of a valid medical device listing among possible other U.S. market authorization attributes) and if the nature and details of the MHRA event meet the U.S. FDA's Medical Device Reporting (MDR) criteria, then a corresponding MDR(s) must be submitted to the FDA within its respective timelines. See 21 CFR Part 803.

Question: If the event which meets the reporting criteria was caused by user error or use error, is the manufacturer required to report?

Answer: Because human factors and usability are expected to be considered when designing a device, use errors/misuse are generally considered to be device nonconformities for which the manufacturer is responsible, not user nonconformities. Yet the MEDDEV generally establishes that use error should be reported if it led to death or serious deterioration in state of health, but not reportable if not unless its trending shows a potential for death or serious deterioration in state of health or public health threat or if a corresponding FSCA was initiated to prevent these outcomes. The U.S. FDA does not give these liberties and generally requires reportable events to be reported regardless of whether, and especially if, it was attributed to user error. FDA has literally said that misuse is a device nonconformity. Health Canada's approach to reporting of use errors is somewhat of a hybrid of Europe's and the U.S.'s (see GUI-0059).

RAPS Expert,

Unfortunately, we got a complaint from one of our distributor in UK that end user injured himself because one of the component is broken during use.
Due to this issue, patient got minor cut and went to hospital for treatment. This is 1st incident specifically related to this problem since we started business (19 years).
We are EU MDR complaint but class I with DOC, FDA complaint, HC complaint, but again class I. 

What are the requirements of reporting to UK health authority and timeline?
Do I need to report EU competent authority as we are sending products as a CE marked in UK?
Do I need to report HC and US-FDA since we are selling same devices to these countries?

We are still collecting information from our distributor such as SRN so didn't log the customer complaint yet?
Also, why incident happened like is it manufacturer fault or user fault? When our time will start for vigilance reporting?

Just in case, if it's user fault, do I still need to report incident, etc. 

Thanks in advance for your expert opinion?

Glad to help; remember that my answers were just some basic rules of thumb not meant to specifically address any particular actual real-life scenario. We would need to know more organic details to be able to definitively advise.

Once a manufacturer has concluded that the event information meets the reportability criteria, then it is generally understood and required that we always submit the adverse event reports by the reporting deadlines even if there is incomplete information. All four of these jurisdictions (EU, UK, CA, FDA) require such initial reports followed by final or follow-up reports to fill in missing information that was not provided or available when the initial report was due.

The expected rule of thumb is that when in doubt (such as due to limited information from the complainant), we report due to the "may have" aspects of the reporting thresholds.

Reference links for?...

The descriptor "minor cuts" is subjective and doesn't clearly align with the fact that the patient went to the hospital for treatment. Thus, without further evaluation by a person qualified to make medical judgments, it leaves open the possibility that the "minor cut" which nonetheless involved a hospital visit meets the definition of serious injury (such as due to a need to seek medical intervention to avoid death or permanent injury; e.g., maybe the patient has a bleeding disorder, maybe the cuts were more severe than you know, maybe the person is vulnerable to infections, or maybe the person just had extra time and money to burn via a trip to the hospital). You need to be able to objectively and medically answer/disarm the dichotomy between the subjective descriptor "minor cuts" allegedly not needing medical intervention vs. the fact that there was a visit to the hospital for treatment.

Be sure you get this right, as failure to submit required adverse event reports is one of the most inflammatory findings for the regulators. For example, with the FDA, failure to submit MDR reports is one of the few direct triggers for a Warning Letter.

There are many nuances and interpretations associated with proper adverse event reporting. Be sure your written procedures systematically incorporate these various permutations into a functional operating solution so that you can make these decisions quickly and properly and methodically on the fly when a deadline is looming over you, rather than trying to scramble with an incomplete understanding. Feel free to reach out to us if you'd like assistance with any of these challenges.

Thanks @Kevin Randall for super detailed response. 

We did some initial investigations with limited information as end user is not very responsive and not providing enough information.
Can we complete investigation and finalize report with very limited info. They just informed, this part is broken and got cuts. Not sure, How we can do complete investigation with limited info?

We're not initiating any FSN / FSCA based on investigation so we don't need to report EU MDR Competent Authority and Health Canada.

Do you have reference links?

Also, I checked FDA requirements for foreign Manufacturer and confirmed we don't need to report FDA as minor cuts incidents have not contributed a death or serious injury.  

We will need to know more organic details in order to give definitive direction for your particular case. And you need to be sure you have comprehensive and properly-written adverse event reporting procedures in place for all affected jurisdictions. But here are some rules of thumb in response to some basic questions:

Question: For a device placed on the market in the UK pursuant to a compliant EU MDR class I self-declaration conformity assessment, must a vigilance report be submitted to the UK's MHRA if there was a "minor cut" that happened in the UK where the patient went to the hospital for treatment?

Answer (Great Britain): If an event actually did occur (see MEDDEV 2 12-1 rev. 8), and if the manufacturer's device is suspected of being a contributory cause of the event, and if the event led to or might have led to (i.e., if it occurred again, it might lead to) a "minor cut" that was life-threatening or a permanent impairment of a body function or a permanent damage to a body structure or necessitated medical (e.g., hospital) or surgical intervention to prevent aforesaid consequences, then the "minor cut" is reportable to the MHRA. Unqualified persons should not be making these medical interpretations about the true clinical/medical nature and extent of the "minor cut"; instead, a person qualified to make such medical judgments is needed.

Note that these criteria are neither contingent on, nor in any way affected by, previously having a flawless 19-year track record.

Answer (Northern Ireland): Apply the EU MDR's serious incident reporting criteria instead, but then, if met, report to the MHRA nonetheless.

Question: What are the requirements of reporting to UK health authority and timeline?

Answer (Great Britain):(summary excluding statement of important details that must in addition be considered): Serious public health threat (see official definition): Immediately but not later than 2 calendar days after awareness by the manufacturer. Death or unanticipated serious deterioration in state of health (see official definition): Immediately but not later than 10 calendar days after date of awareness. Others: Immediately but not later than 30 calendar days after date of awareness.

Answer (Northern Ireland): See the EU MDR's Article 87(2) through 87(7) timelines.

Question: If the aforesaid event is reportable to the MHRA, is it also reportable to a European Competent Authority(s)?

Answer: If the UK incident led to FSCA of devices that were also placed on the market in Europe's Union, then an FSCA must also be initiated and reported with respect to the affected European Competent Authority(s).

Question: If the aforesaid event is reportable to the MHRA, is it also reportable to Health Canada?

Answer: Yes, if an FSCA has been initiated with the MHRA and the issue is relevant for devices authorized for sale in Canada and there is no prior Canadian Incident Report already submitted for a prior occurrence of this event that has the same root cause and the latest UK occurrence resulted in another corrective action separate from the first.

Question: If the aforesaid event is reportable to the MHRA, is it also reportable to the U.S. FDA?

Answer: If the subject device is legally marketed in the U.S. (e.g., is the subject of a valid medical device listing among possible other U.S. market authorization attributes) and if the nature and details of the MHRA event meet the U.S. FDA's Medical Device Reporting (MDR) criteria, then a corresponding MDR(s) must be submitted to the FDA within its respective timelines. See 21 CFR Part 803.

Question: If the event which meets the reporting criteria was caused by user error or use error, is the manufacturer required to report?

Answer: Because human factors and usability are expected to be considered when designing a device, use errors/misuse are generally considered to be device nonconformities for which the manufacturer is responsible, not user nonconformities. Yet the MEDDEV generally establishes that use error should be reported if it led to death or serious deterioration in state of health, but not reportable if not unless its trending shows a potential for death or serious deterioration in state of health or public health threat or if a corresponding FSCA was initiated to prevent these outcomes. The U.S. FDA does not give these liberties and generally requires reportable events to be reported regardless of whether, and especially if, it was attributed to user error. FDA has literally said that misuse is a device nonconformity. Health Canada's approach to reporting of use errors is somewhat of a hybrid of Europe's and the U.S.'s (see GUI-0059).

RAPS Expert,

Unfortunately, we got a complaint from one of our distributor in UK that end user injured himself because one of the component is broken during use.
Due to this issue, patient got minor cut and went to hospital for treatment. This is 1st incident specifically related to this problem since we started business (19 years).
We are EU MDR complaint but class I with DOC, FDA complaint, HC complaint, but again class I. 

What are the requirements of reporting to UK health authority and timeline?
Do I need to report EU competent authority as we are sending products as a CE marked in UK?
Do I need to report HC and US-FDA since we are selling same devices to these countries?

We are still collecting information from our distributor such as SRN so didn't log the customer complaint yet?
Also, why incident happened like is it manufacturer fault or user fault? When our time will start for vigilance reporting?

Just in case, if it's user fault, do I still need to report incident, etc. 

Thanks in advance for your expert opinion?

Again thanks.

I guess, it's better to report to FDA and UK-MHRA even though minor cuts because end user went to hospital.
Since, we are not initiating FSCA so don't need to report to HC, EU.

If it's reportable incident as per UK-MHRA then it would make adverse event incident in FDA and thus reporting to FDA is required even though incident happened in UK.
Is that you mean in above response?

Note: We do sell same kinda products in US, EU as well. 

Glad to help; remember that my answers were just some basic rules of thumb not meant to specifically address any particular actual real-life scenario. We would need to know more organic details to be able to definitively advise.

Once a manufacturer has concluded that the event information meets the reportability criteria, then it is generally understood and required that we always submit the adverse event reports by the reporting deadlines even if there is incomplete information. All four of these jurisdictions (EU, UK, CA, FDA) require such initial reports followed by final or follow-up reports to fill in missing information that was not provided or available when the initial report was due.

The expected rule of thumb is that when in doubt (such as due to limited information from the complainant), we report due to the "may have" aspects of the reporting thresholds.

Reference links for?...

The descriptor "minor cuts" is subjective and doesn't clearly align with the fact that the patient went to the hospital for treatment. Thus, without further evaluation by a person qualified to make medical judgments, it leaves open the possibility that the "minor cut" which nonetheless involved a hospital visit meets the definition of serious injury (such as due to a need to seek medical intervention to avoid death or permanent injury; e.g., maybe the patient has a bleeding disorder, maybe the cuts were more severe than you know, maybe the person is vulnerable to infections, or maybe the person just had extra time and money to burn via a trip to the hospital). You need to be able to objectively and medically answer/disarm the dichotomy between the subjective descriptor "minor cuts" allegedly not needing medical intervention vs. the fact that there was a visit to the hospital for treatment.

Be sure you get this right, as failure to submit required adverse event reports is one of the most inflammatory findings for the regulators. For example, with the FDA, failure to submit MDR reports is one of the few direct triggers for a Warning Letter.

There are many nuances and interpretations associated with proper adverse event reporting. Be sure your written procedures systematically incorporate these various permutations into a functional operating solution so that you can make these decisions quickly and properly and methodically on the fly when a deadline is looming over you, rather than trying to scramble with an incomplete understanding. Feel free to reach out to us if you'd like assistance with any of these challenges.

Thanks @Kevin Randall for super detailed response. 

We did some initial investigations with limited information as end user is not very responsive and not providing enough information.
Can we complete investigation and finalize report with very limited info. They just informed, this part is broken and got cuts. Not sure, How we can do complete investigation with limited info?

We're not initiating any FSN / FSCA based on investigation so we don't need to report EU MDR Competent Authority and Health Canada.

Do you have reference links?

Also, I checked FDA requirements for foreign Manufacturer and confirmed we don't need to report FDA as minor cuts incidents have not contributed a death or serious injury.  

We will need to know more organic details in order to give definitive direction for your particular case. And you need to be sure you have comprehensive and properly-written adverse event reporting procedures in place for all affected jurisdictions. But here are some rules of thumb in response to some basic questions:

Question: For a device placed on the market in the UK pursuant to a compliant EU MDR class I self-declaration conformity assessment, must a vigilance report be submitted to the UK's MHRA if there was a "minor cut" that happened in the UK where the patient went to the hospital for treatment?

Answer (Great Britain): If an event actually did occur (see MEDDEV 2 12-1 rev. 8), and if the manufacturer's device is suspected of being a contributory cause of the event, and if the event led to or might have led to (i.e., if it occurred again, it might lead to) a "minor cut" that was life-threatening or a permanent impairment of a body function or a permanent damage to a body structure or necessitated medical (e.g., hospital) or surgical intervention to prevent aforesaid consequences, then the "minor cut" is reportable to the MHRA. Unqualified persons should not be making these medical interpretations about the true clinical/medical nature and extent of the "minor cut"; instead, a person qualified to make such medical judgments is needed.

Note that these criteria are neither contingent on, nor in any way affected by, previously having a flawless 19-year track record.

Answer (Northern Ireland): Apply the EU MDR's serious incident reporting criteria instead, but then, if met, report to the MHRA nonetheless.

Question: What are the requirements of reporting to UK health authority and timeline?

Answer (Great Britain):(summary excluding statement of important details that must in addition be considered): Serious public health threat (see official definition): Immediately but not later than 2 calendar days after awareness by the manufacturer. Death or unanticipated serious deterioration in state of health (see official definition): Immediately but not later than 10 calendar days after date of awareness. Others: Immediately but not later than 30 calendar days after date of awareness.

Answer (Northern Ireland): See the EU MDR's Article 87(2) through 87(7) timelines.

Question: If the aforesaid event is reportable to the MHRA, is it also reportable to a European Competent Authority(s)?

Answer: If the UK incident led to FSCA of devices that were also placed on the market in Europe's Union, then an FSCA must also be initiated and reported with respect to the affected European Competent Authority(s).

Question: If the aforesaid event is reportable to the MHRA, is it also reportable to Health Canada?

Answer: Yes, if an FSCA has been initiated with the MHRA and the issue is relevant for devices authorized for sale in Canada and there is no prior Canadian Incident Report already submitted for a prior occurrence of this event that has the same root cause and the latest UK occurrence resulted in another corrective action separate from the first.

Question: If the aforesaid event is reportable to the MHRA, is it also reportable to the U.S. FDA?

Answer: If the subject device is legally marketed in the U.S. (e.g., is the subject of a valid medical device listing among possible other U.S. market authorization attributes) and if the nature and details of the MHRA event meet the U.S. FDA's Medical Device Reporting (MDR) criteria, then a corresponding MDR(s) must be submitted to the FDA within its respective timelines. See 21 CFR Part 803.

Question: If the event which meets the reporting criteria was caused by user error or use error, is the manufacturer required to report?

Answer: Because human factors and usability are expected to be considered when designing a device, use errors/misuse are generally considered to be device nonconformities for which the manufacturer is responsible, not user nonconformities. Yet the MEDDEV generally establishes that use error should be reported if it led to death or serious deterioration in state of health, but not reportable if not unless its trending shows a potential for death or serious deterioration in state of health or public health threat or if a corresponding FSCA was initiated to prevent these outcomes. The U.S. FDA does not give these liberties and generally requires reportable events to be reported regardless of whether, and especially if, it was attributed to user error. FDA has literally said that misuse is a device nonconformity. Health Canada's approach to reporting of use errors is somewhat of a hybrid of Europe's and the U.S.'s (see GUI-0059).

RAPS Expert,

Unfortunately, we got a complaint from one of our distributor in UK that end user injured himself because one of the component is broken during use.
Due to this issue, patient got minor cut and went to hospital for treatment. This is 1st incident specifically related to this problem since we started business (19 years).
We are EU MDR complaint but class I with DOC, FDA complaint, HC complaint, but again class I. 

What are the requirements of reporting to UK health authority and timeline?
Do I need to report EU competent authority as we are sending products as a CE marked in UK?
Do I need to report HC and US-FDA since we are selling same devices to these countries?

We are still collecting information from our distributor such as SRN so didn't log the customer complaint yet?
Also, why incident happened like is it manufacturer fault or user fault? When our time will start for vigilance reporting?

Just in case, if it's user fault, do I still need to report incident, etc. 

Thanks in advance for your expert opinion?

Sometimes there can be a fair amount of subjectivity on this topic, and there may be divergent opinions or different ways to look at it. My replies are just my interpretations based on prior experience (nearly 30 years). Others are welcomed to chime in too, as all insights are welcomed. 

Regarding FDA's requirement for reporting of foreign events, here is a snippet from FDA's guidance document:

4.11.3 I'm a foreign manufacturer of a device that has been cleared or approved in the US and is also lawfully marketed in a foreign country. If an adverse event occurs in a foreign country with the device, must the event in the foreign country be reported under the MDR regulation?

Yes, FDA considers an event that occurs in a foreign country reportable under the MDR regulation if it involves a device that has been cleared or approved in the US – or a device similar to a device marketed by the manufacturer that has been cleared or approved in the US – and is also lawfully marketed in a foreign country. Devices may be manufactured to slightly modified specifications to meet standards in different countries. If these changes do not substantially alter the performance of the device, then any device events that are MDR reportable events relating to such modified devices should be reported under the MDR regulation (see section 2.14 of this guidance).

Again thanks.

I guess, it's better to report to FDA and UK-MHRA even though minor cuts because end user went to hospital.
Since, we are not initiating FSCA so don't need to report to HC, EU.

If it's reportable incident as per UK-MHRA then it would make adverse event incident in FDA and thus reporting to FDA is required even though incident happened in UK.
Is that you mean in above response?

Note: We do sell same kinda products in US, EU as well. 

Glad to help; remember that my answers were just some basic rules of thumb not meant to specifically address any particular actual real-life scenario. We would need to know more organic details to be able to definitively advise.

Once a manufacturer has concluded that the event information meets the reportability criteria, then it is generally understood and required that we always submit the adverse event reports by the reporting deadlines even if there is incomplete information. All four of these jurisdictions (EU, UK, CA, FDA) require such initial reports followed by final or follow-up reports to fill in missing information that was not provided or available when the initial report was due.

The expected rule of thumb is that when in doubt (such as due to limited information from the complainant), we report due to the "may have" aspects of the reporting thresholds.

Reference links for?...

The descriptor "minor cuts" is subjective and doesn't clearly align with the fact that the patient went to the hospital for treatment. Thus, without further evaluation by a person qualified to make medical judgments, it leaves open the possibility that the "minor cut" which nonetheless involved a hospital visit meets the definition of serious injury (such as due to a need to seek medical intervention to avoid death or permanent injury; e.g., maybe the patient has a bleeding disorder, maybe the cuts were more severe than you know, maybe the person is vulnerable to infections, or maybe the person just had extra time and money to burn via a trip to the hospital). You need to be able to objectively and medically answer/disarm the dichotomy between the subjective descriptor "minor cuts" allegedly not needing medical intervention vs. the fact that there was a visit to the hospital for treatment.

Be sure you get this right, as failure to submit required adverse event reports is one of the most inflammatory findings for the regulators. For example, with the FDA, failure to submit MDR reports is one of the few direct triggers for a Warning Letter.

There are many nuances and interpretations associated with proper adverse event reporting. Be sure your written procedures systematically incorporate these various permutations into a functional operating solution so that you can make these decisions quickly and properly and methodically on the fly when a deadline is looming over you, rather than trying to scramble with an incomplete understanding. Feel free to reach out to us if you'd like assistance with any of these challenges.

Thanks @Kevin Randall for super detailed response. 

We did some initial investigations with limited information as end user is not very responsive and not providing enough information.
Can we complete investigation and finalize report with very limited info. They just informed, this part is broken and got cuts. Not sure, How we can do complete investigation with limited info?

We're not initiating any FSN / FSCA based on investigation so we don't need to report EU MDR Competent Authority and Health Canada.

Do you have reference links?

Also, I checked FDA requirements for foreign Manufacturer and confirmed we don't need to report FDA as minor cuts incidents have not contributed a death or serious injury.  

We will need to know more organic details in order to give definitive direction for your particular case. And you need to be sure you have comprehensive and properly-written adverse event reporting procedures in place for all affected jurisdictions. But here are some rules of thumb in response to some basic questions:

Question: For a device placed on the market in the UK pursuant to a compliant EU MDR class I self-declaration conformity assessment, must a vigilance report be submitted to the UK's MHRA if there was a "minor cut" that happened in the UK where the patient went to the hospital for treatment?

Answer (Great Britain): If an event actually did occur (see MEDDEV 2 12-1 rev. 8), and if the manufacturer's device is suspected of being a contributory cause of the event, and if the event led to or might have led to (i.e., if it occurred again, it might lead to) a "minor cut" that was life-threatening or a permanent impairment of a body function or a permanent damage to a body structure or necessitated medical (e.g., hospital) or surgical intervention to prevent aforesaid consequences, then the "minor cut" is reportable to the MHRA. Unqualified persons should not be making these medical interpretations about the true clinical/medical nature and extent of the "minor cut"; instead, a person qualified to make such medical judgments is needed.

Note that these criteria are neither contingent on, nor in any way affected by, previously having a flawless 19-year track record.

Answer (Northern Ireland): Apply the EU MDR's serious incident reporting criteria instead, but then, if met, report to the MHRA nonetheless.

Question: What are the requirements of reporting to UK health authority and timeline?

Answer (Great Britain):(summary excluding statement of important details that must in addition be considered): Serious public health threat (see official definition): Immediately but not later than 2 calendar days after awareness by the manufacturer. Death or unanticipated serious deterioration in state of health (see official definition): Immediately but not later than 10 calendar days after date of awareness. Others: Immediately but not later than 30 calendar days after date of awareness.

Answer (Northern Ireland): See the EU MDR's Article 87(2) through 87(7) timelines.

Question: If the aforesaid event is reportable to the MHRA, is it also reportable to a European Competent Authority(s)?

Answer: If the UK incident led to FSCA of devices that were also placed on the market in Europe's Union, then an FSCA must also be initiated and reported with respect to the affected European Competent Authority(s).

Question: If the aforesaid event is reportable to the MHRA, is it also reportable to Health Canada?

Answer: Yes, if an FSCA has been initiated with the MHRA and the issue is relevant for devices authorized for sale in Canada and there is no prior Canadian Incident Report already submitted for a prior occurrence of this event that has the same root cause and the latest UK occurrence resulted in another corrective action separate from the first.

Question: If the aforesaid event is reportable to the MHRA, is it also reportable to the U.S. FDA?

Answer: If the subject device is legally marketed in the U.S. (e.g., is the subject of a valid medical device listing among possible other U.S. market authorization attributes) and if the nature and details of the MHRA event meet the U.S. FDA's Medical Device Reporting (MDR) criteria, then a corresponding MDR(s) must be submitted to the FDA within its respective timelines. See 21 CFR Part 803.

Question: If the event which meets the reporting criteria was caused by user error or use error, is the manufacturer required to report?

Answer: Because human factors and usability are expected to be considered when designing a device, use errors/misuse are generally considered to be device nonconformities for which the manufacturer is responsible, not user nonconformities. Yet the MEDDEV generally establishes that use error should be reported if it led to death or serious deterioration in state of health, but not reportable if not unless its trending shows a potential for death or serious deterioration in state of health or public health threat or if a corresponding FSCA was initiated to prevent these outcomes. The U.S. FDA does not give these liberties and generally requires reportable events to be reported regardless of whether, and especially if, it was attributed to user error. FDA has literally said that misuse is a device nonconformity. Health Canada's approach to reporting of use errors is somewhat of a hybrid of Europe's and the U.S.'s (see GUI-0059).

RAPS Expert,

Unfortunately, we got a complaint from one of our distributor in UK that end user injured himself because one of the component is broken during use.
Due to this issue, patient got minor cut and went to hospital for treatment. This is 1st incident specifically related to this problem since we started business (19 years).
We are EU MDR complaint but class I with DOC, FDA complaint, HC complaint, but again class I. 

What are the requirements of reporting to UK health authority and timeline?
Do I need to report EU competent authority as we are sending products as a CE marked in UK?
Do I need to report HC and US-FDA since we are selling same devices to these countries?

We are still collecting information from our distributor such as SRN so didn't log the customer complaint yet?
Also, why incident happened like is it manufacturer fault or user fault? When our time will start for vigilance reporting?

Just in case, if it's user fault, do I still need to report incident, etc. 

Thanks in advance for your expert opinion?