Regulatory Open Forum

In general the reporting period begins on the day after the awareness date of any potential serious incident at 00:00:01 (12:00:01 AM).

There can be a little more to it depending on bank holidays etc if you want to put in some more details on specifics please do.

Christina,

It is generally understood as a single incident, e.g. a customer complaint which is received, where each one would need to be evaluated for reportability.  Each complaint would be evaluated for a Serious Public Health Threat (SPHT) to determine if the "time" would start or not.  This may not be readily evident with only one complaint or the first complaint.  Therefore, when a SPHT becomes apparent or potentially identified, then that is when the time starts.  Also keep in mind, the determination or potential determination can be quite subjective to many different people - in my experience a serious public threat is readily apparent because there is something serious happening or has happened.

In general the reporting period begins on the day after the awareness date of any potential serious incident at 00:00:01 (12:00:01 AM).

There can be a little more to it depending on bank holidays etc if you want to put in some more details on specifics please do.

Hi Christina,

As Bryndis Gudnadottir already mentioned, see MDCG 2023-3. This states that the clock starts ticking at midnight (your local time) at the end of the day you first became aware. These are callendar days. As an example, if you would have learned last year on Friday 22 December, you would have had until Sunday 24, Christmas evening, to submit. 

If you want to have a smart procedure, just be aware that you don't need to label an incident as being a serious public health threat. It can be anything, it is up to the authorities to label this event. By reporting within two days, you will be in time regardless of the type of incident. It is also important to realise, you can enter a report that is still missing data and update later. With that in mind, I would recommend to develop a procedure that quickly identifies potential high-risk cases and escalates them to a high level of attention. Bottom line: when in doubt, report immediately and fill in the blanks later. If you do this, you will make life for the vigilance staff (and for the rest of the organization) much easier. 

For those thinking they will draw attention if they report incidents, just realise that the authorities have dozens of incidents coming in every day. For them, these reports are routine matters. In the case you draw attention, it will most likely be in the form of scoring bonus points for being early with your reports. I know this, because I worked there and helped developing risk based reporting systems. 

Hi Christina,

As Bryndis Gudnadottir already mentioned, see MDCG 2023-3. This states that the clock starts ticking at midnight (your local time) at the end of the day you first became aware. These are callendar days. As an example, if you would have learned last year on Friday 22 December, you would have had until Sunday 24, Christmas evening, to submit. 

If you want to have a smart procedure, just be aware that you don't need to label an incident as being a serious public health threat. It can be anything, it is up to the authorities to label this event. By reporting within two days, you will be in time regardless of the type of incident. It is also important to realise, you can enter a report that is still missing data and update later. With that in mind, I would recommend to develop a procedure that quickly identifies potential high-risk cases and escalates them to a high level of attention. Bottom line: when in doubt, report immediately and fill in the blanks later. If you do this, you will make life for the vigilance staff (and for the rest of the organization) much easier. 

For those thinking they will draw attention if they report incidents, just realise that the authorities have dozens of incidents coming in every day. For them, these reports are routine matters. In the case you draw attention, it will most likely be in the form of scoring bonus points for being early with your reports. I know this, because I worked there and helped developing risk based reporting systems. 

Common misconception here is that it is always 2 days and it's a big fat can of worms but in the above example where the last day of a period is a bank holiday, saturday or sunday the reporting period shall end at the end of the following working day. So depending on your member state where the 25th and 26th are public holidays and you could have until the 27th to report.

I do full agree that best practice as ever - is to report immediately.

Hi Christina,

As Bryndis Gudnadottir already mentioned, see MDCG 2023-3. This states that the clock starts ticking at midnight (your local time) at the end of the day you first became aware. These are callendar days. As an example, if you would have learned last year on Friday 22 December, you would have had until Sunday 24, Christmas evening, to submit. 

If you want to have a smart procedure, just be aware that you don't need to label an incident as being a serious public health threat. It can be anything, it is up to the authorities to label this event. By reporting within two days, you will be in time regardless of the type of incident. It is also important to realise, you can enter a report that is still missing data and update later. With that in mind, I would recommend to develop a procedure that quickly identifies potential high-risk cases and escalates them to a high level of attention. Bottom line: when in doubt, report immediately and fill in the blanks later. If you do this, you will make life for the vigilance staff (and for the rest of the organization) much easier. 

For those thinking they will draw attention if they report incidents, just realise that the authorities have dozens of incidents coming in every day. For them, these reports are routine matters. In the case you draw attention, it will most likely be in the form of scoring bonus points for being early with your reports. I know this, because I worked there and helped developing risk based reporting systems. 

Common misconception here is that it is always 2 days and it's a big fat can of worms but in the above example where the last day of a period is a bank holiday, saturday or sunday the reporting period shall end at the end of the following working day. So depending on your member state where the 25th and 26th are public holidays and you could have until the 27th to report.

I do full agree that best practice as ever - is to report immediately.

Hi Christina,

As Bryndis Gudnadottir already mentioned, see MDCG 2023-3. This states that the clock starts ticking at midnight (your local time) at the end of the day you first became aware. These are callendar days. As an example, if you would have learned last year on Friday 22 December, you would have had until Sunday 24, Christmas evening, to submit. 

If you want to have a smart procedure, just be aware that you don't need to label an incident as being a serious public health threat. It can be anything, it is up to the authorities to label this event. By reporting within two days, you will be in time regardless of the type of incident. It is also important to realise, you can enter a report that is still missing data and update later. With that in mind, I would recommend to develop a procedure that quickly identifies potential high-risk cases and escalates them to a high level of attention. Bottom line: when in doubt, report immediately and fill in the blanks later. If you do this, you will make life for the vigilance staff (and for the rest of the organization) much easier. 

For those thinking they will draw attention if they report incidents, just realise that the authorities have dozens of incidents coming in every day. For them, these reports are routine matters. In the case you draw attention, it will most likely be in the form of scoring bonus points for being early with your reports. I know this, because I worked there and helped developing risk based reporting systems. 

Common misconception here is that it is always 2 days and it's a big fat can of worms but in the above example where the last day of a period is a bank holiday, saturday or sunday the reporting period shall end at the end of the following working day. So depending on your member state where the 25th and 26th are public holidays and you could have until the 27th to report.

I do full agree that best practice as ever - is to report immediately.

Hi Christina,

As Bryndis Gudnadottir already mentioned, see MDCG 2023-3. This states that the clock starts ticking at midnight (your local time) at the end of the day you first became aware. These are callendar days. As an example, if you would have learned last year on Friday 22 December, you would have had until Sunday 24, Christmas evening, to submit. 

If you want to have a smart procedure, just be aware that you don't need to label an incident as being a serious public health threat. It can be anything, it is up to the authorities to label this event. By reporting within two days, you will be in time regardless of the type of incident. It is also important to realise, you can enter a report that is still missing data and update later. With that in mind, I would recommend to develop a procedure that quickly identifies potential high-risk cases and escalates them to a high level of attention. Bottom line: when in doubt, report immediately and fill in the blanks later. If you do this, you will make life for the vigilance staff (and for the rest of the organization) much easier. 

For those thinking they will draw attention if they report incidents, just realise that the authorities have dozens of incidents coming in every day. For them, these reports are routine matters. In the case you draw attention, it will most likely be in the form of scoring bonus points for being early with your reports. I know this, because I worked there and helped developing risk based reporting systems. 

Hi Chris

I think you are right that in most cases the SPHT will be identified through investigation, so the clock will begin at the time when the investigation reaches that conclusion. Not necessarily when the investigation is complete, because that might take longer. And not necessarily when the complaint first comes in, because you might not know at first that there is a SPHT, although if there is a suspicion of something serious you will want to expedite the investigation.

Trying to imagine a case where a SPHT might be identified on receipt of a complaint... Maybe if you had a threshold for a number of incidents, one complaint would be the one that crossed the threshold. Maybe one complaint says something alarming like "we tested your sterile substance on receipt and found massive contamination".

Complaint handlers may not have the expertise to judge SPHT for any given complaint, but they probably do have the expertise to select a subset of complaints that warrant escalation for additional review.

Common misconception here is that it is always 2 days and it's a big fat can of worms but in the above example where the last day of a period is a bank holiday, saturday or sunday the reporting period shall end at the end of the following working day. So depending on your member state where the 25th and 26th are public holidays and you could have until the 27th to report.

I do full agree that best practice as ever - is to report immediately.

Hi Christina,

As Bryndis Gudnadottir already mentioned, see MDCG 2023-3. This states that the clock starts ticking at midnight (your local time) at the end of the day you first became aware. These are callendar days. As an example, if you would have learned last year on Friday 22 December, you would have had until Sunday 24, Christmas evening, to submit. 

If you want to have a smart procedure, just be aware that you don't need to label an incident as being a serious public health threat. It can be anything, it is up to the authorities to label this event. By reporting within two days, you will be in time regardless of the type of incident. It is also important to realise, you can enter a report that is still missing data and update later. With that in mind, I would recommend to develop a procedure that quickly identifies potential high-risk cases and escalates them to a high level of attention. Bottom line: when in doubt, report immediately and fill in the blanks later. If you do this, you will make life for the vigilance staff (and for the rest of the organization) much easier. 

For those thinking they will draw attention if they report incidents, just realise that the authorities have dozens of incidents coming in every day. For them, these reports are routine matters. In the case you draw attention, it will most likely be in the form of scoring bonus points for being early with your reports. I know this, because I worked there and helped developing risk based reporting systems. 

Hi Chris

I think you are right that in most cases the SPHT will be identified through investigation, so the clock will begin at the time when the investigation reaches that conclusion. Not necessarily when the investigation is complete, because that might take longer. And not necessarily when the complaint first comes in, because you might not know at first that there is a SPHT, although if there is a suspicion of something serious you will want to expedite the investigation.

Trying to imagine a case where a SPHT might be identified on receipt of a complaint... Maybe if you had a threshold for a number of incidents, one complaint would be the one that crossed the threshold. Maybe one complaint says something alarming like "we tested your sterile substance on receipt and found massive contamination".

Complaint handlers may not have the expertise to judge SPHT for any given complaint, but they probably do have the expertise to select a subset of complaints that warrant escalation for additional review.

Common misconception here is that it is always 2 days and it's a big fat can of worms but in the above example where the last day of a period is a bank holiday, saturday or sunday the reporting period shall end at the end of the following working day. So depending on your member state where the 25th and 26th are public holidays and you could have until the 27th to report.

I do full agree that best practice as ever - is to report immediately.

Hi Christina,

As Bryndis Gudnadottir already mentioned, see MDCG 2023-3. This states that the clock starts ticking at midnight (your local time) at the end of the day you first became aware. These are callendar days. As an example, if you would have learned last year on Friday 22 December, you would have had until Sunday 24, Christmas evening, to submit. 

If you want to have a smart procedure, just be aware that you don't need to label an incident as being a serious public health threat. It can be anything, it is up to the authorities to label this event. By reporting within two days, you will be in time regardless of the type of incident. It is also important to realise, you can enter a report that is still missing data and update later. With that in mind, I would recommend to develop a procedure that quickly identifies potential high-risk cases and escalates them to a high level of attention. Bottom line: when in doubt, report immediately and fill in the blanks later. If you do this, you will make life for the vigilance staff (and for the rest of the organization) much easier. 

For those thinking they will draw attention if they report incidents, just realise that the authorities have dozens of incidents coming in every day. For them, these reports are routine matters. In the case you draw attention, it will most likely be in the form of scoring bonus points for being early with your reports. I know this, because I worked there and helped developing risk based reporting systems. 

Notwithstanding considerations of practicality or sensibility, MDCG 2023-3 seems quite clear that we aren't allowed to wait until after our investigation to start the clock. Instead, MDCG 2023-3 starts the clock when the complaint is received.  Here are a couple excerpts:

• "...The awareness date (day=0) refers to the date when the manufacturer is first made aware or receives information of the occurrence of the (potentially) serious incident and not after it has conducted its investigation..." [emphasis added]

• "...the 'manufacturer awareness date' is the date when the first employee or representative of the manufacturer's organisation, receives information (e.g. a complaint) regarding the potentially serious incident..." [emphasis added]

Hi Chris

I think you are right that in most cases the SPHT will be identified through investigation, so the clock will begin at the time when the investigation reaches that conclusion. Not necessarily when the investigation is complete, because that might take longer. And not necessarily when the complaint first comes in, because you might not know at first that there is a SPHT, although if there is a suspicion of something serious you will want to expedite the investigation.

Trying to imagine a case where a SPHT might be identified on receipt of a complaint... Maybe if you had a threshold for a number of incidents, one complaint would be the one that crossed the threshold. Maybe one complaint says something alarming like "we tested your sterile substance on receipt and found massive contamination".

Complaint handlers may not have the expertise to judge SPHT for any given complaint, but they probably do have the expertise to select a subset of complaints that warrant escalation for additional review.

Common misconception here is that it is always 2 days and it's a big fat can of worms but in the above example where the last day of a period is a bank holiday, saturday or sunday the reporting period shall end at the end of the following working day. So depending on your member state where the 25th and 26th are public holidays and you could have until the 27th to report.

I do full agree that best practice as ever - is to report immediately.

Hi Christina,

As Bryndis Gudnadottir already mentioned, see MDCG 2023-3. This states that the clock starts ticking at midnight (your local time) at the end of the day you first became aware. These are callendar days. As an example, if you would have learned last year on Friday 22 December, you would have had until Sunday 24, Christmas evening, to submit. 

If you want to have a smart procedure, just be aware that you don't need to label an incident as being a serious public health threat. It can be anything, it is up to the authorities to label this event. By reporting within two days, you will be in time regardless of the type of incident. It is also important to realise, you can enter a report that is still missing data and update later. With that in mind, I would recommend to develop a procedure that quickly identifies potential high-risk cases and escalates them to a high level of attention. Bottom line: when in doubt, report immediately and fill in the blanks later. If you do this, you will make life for the vigilance staff (and for the rest of the organization) much easier. 

For those thinking they will draw attention if they report incidents, just realise that the authorities have dozens of incidents coming in every day. For them, these reports are routine matters. In the case you draw attention, it will most likely be in the form of scoring bonus points for being early with your reports. I know this, because I worked there and helped developing risk based reporting systems. 

Hi Kevin

Yes, for serious incidents in general, and potentially serious incidents, awareness usually begins when the complaint is received. Specifically for serious public health threats, though, see MDCG 2023-3 sections

"A serious threat to public health will in principle not be limited to one isolated case or individual patient issue, and identifying these events may depend on signal detection or trending of multiple events of the same nature/typology, same root cause, etc." And

"A serious public health threat must be reported immediately, and not later than 2 days after the manufacturer becomes aware of that threat (Article 87(4) MDR)"

Then the report will probably go on to explain what pieces of information were received when and how the manufacturer came to that state of awareness.

Practically and sensibly, I'd hope when SPHTs do happen there's a channel available for immediate recognition and escalation, to solve the problem as well as reporting it.

Notwithstanding considerations of practicality or sensibility, MDCG 2023-3 seems quite clear that we aren't allowed to wait until after our investigation to start the clock. Instead, MDCG 2023-3 starts the clock when the complaint is received.  Here are a couple excerpts:

• "...The awareness date (day=0) refers to the date when the manufacturer is first made aware or receives information of the occurrence of the (potentially) serious incident and not after it has conducted its investigation..." [emphasis added]

• "...the 'manufacturer awareness date' is the date when the first employee or representative of the manufacturer's organisation, receives information (e.g. a complaint) regarding the potentially serious incident..." [emphasis added]

Hi Chris

I think you are right that in most cases the SPHT will be identified through investigation, so the clock will begin at the time when the investigation reaches that conclusion. Not necessarily when the investigation is complete, because that might take longer. And not necessarily when the complaint first comes in, because you might not know at first that there is a SPHT, although if there is a suspicion of something serious you will want to expedite the investigation.

Trying to imagine a case where a SPHT might be identified on receipt of a complaint... Maybe if you had a threshold for a number of incidents, one complaint would be the one that crossed the threshold. Maybe one complaint says something alarming like "we tested your sterile substance on receipt and found massive contamination".

Complaint handlers may not have the expertise to judge SPHT for any given complaint, but they probably do have the expertise to select a subset of complaints that warrant escalation for additional review.

Common misconception here is that it is always 2 days and it's a big fat can of worms but in the above example where the last day of a period is a bank holiday, saturday or sunday the reporting period shall end at the end of the following working day. So depending on your member state where the 25th and 26th are public holidays and you could have until the 27th to report.

I do full agree that best practice as ever - is to report immediately.

Hi Christina,

As Bryndis Gudnadottir already mentioned, see MDCG 2023-3. This states that the clock starts ticking at midnight (your local time) at the end of the day you first became aware. These are callendar days. As an example, if you would have learned last year on Friday 22 December, you would have had until Sunday 24, Christmas evening, to submit. 

If you want to have a smart procedure, just be aware that you don't need to label an incident as being a serious public health threat. It can be anything, it is up to the authorities to label this event. By reporting within two days, you will be in time regardless of the type of incident. It is also important to realise, you can enter a report that is still missing data and update later. With that in mind, I would recommend to develop a procedure that quickly identifies potential high-risk cases and escalates them to a high level of attention. Bottom line: when in doubt, report immediately and fill in the blanks later. If you do this, you will make life for the vigilance staff (and for the rest of the organization) much easier. 

For those thinking they will draw attention if they report incidents, just realise that the authorities have dozens of incidents coming in every day. For them, these reports are routine matters. In the case you draw attention, it will most likely be in the form of scoring bonus points for being early with your reports. I know this, because I worked there and helped developing risk based reporting systems. 

I see that everybody is happily using the term complaint, but note that as Tom Patten stated: complaint is not the trigger event, it's awareness. Awareness does not necessarily start upon receipt of a complaint. As lawyer to a lot of medical devices companies I see the focus on receipt of a complaint as a trigger event for vigilance reporting cause problems time and time again. Complaint is not a defined concept in the MDR, so it's very tricky to rely on this as a trigger event, even if it's defined in other legal systems. So in the above example the clock may in fact have started BEFORE the complaint was received, if the manufacturer had awareness before this moment. 

------------------------------
Erik Vollebregt
Partner
Amsterdam
Netherlands

Original Message:
Sent: 04-Jan-2024 02:09
From: Christina Donegan
Subject: Complaint Handling and Reporting - MDR - Serious Public Health Threat

I see that everybody is happily using the term complaint, but note that as Tom Patten stated: complaint is not the trigger event, it's awareness. Awareness does not necessarily start upon receipt of a complaint. As lawyer to a lot of medical devices companies I see the focus on receipt of a complaint as a trigger event for vigilance reporting cause problems time and time again. Complaint is not a defined concept in the MDR, so it's very tricky to rely on this as a trigger event, even if it's defined in other legal systems. So in the above example the clock may in fact have started BEFORE the complaint was received, if the manufacturer had awareness before this moment. 

------------------------------
Erik Vollebregt
Partner
Amsterdam
Netherlands

Original Message:
Sent: 04-Jan-2024 02:09
From: Christina Donegan
Subject: Complaint Handling and Reporting - MDR - Serious Public Health Threat