Regulatory Open Forum

Hi,

Could someone clarify the difference between Residual risks and side effects in the context of the MDR ? or do they mean the same ?

thanks

Residual risks come from EN ISO 14971:2019/A11:2021. They are the risks remaining after implementing the risk control measures.

Side effects are unintended results of using the device. Side effects are residual risks, but not all residual risks are side effects.

Because of the EU-MDR I recommend that in the risk management hazard analysis include a column for both residual risks and side effects. While side effects are residual risks, it is more convenient to break them out separately.

Under the EU-MDR, disclose all residual risks (including side effects) in the limitations, contra-indications, precautions, or warnings section of the information supplied by the manufacturer.

Use the information on side effects in the Article 88 Trend reporting.

Hi,

Could someone clarify the difference between Residual risks and side effects in the context of the MDR ? or do they mean the same ?

thanks

Good day Anon,

Concur with Dan that side effects are residual risks, but not all residual risks are side effects.  Definitely either put a "notation" of a residual risk being a side effect or potential side effect or keep a separate list somewhere in the risk summary report of side effects.  Think of residual risks as something that could happen if something was done wrong or the hazardous situation decided to pop its head up.  Whereas a side effect is usually something which can often happen with a quite small percent of the population, i.e. a good example is an allergic reaction to some material.  Also keep in mind, most medical devices do not have side effects (such as in the pharmaceutical world), though many medical devices have residual risks.

Residual risks come from EN ISO 14971:2019/A11:2021. They are the risks remaining after implementing the risk control measures.

Side effects are unintended results of using the device. Side effects are residual risks, but not all residual risks are side effects.

Because of the EU-MDR I recommend that in the risk management hazard analysis include a column for both residual risks and side effects. While side effects are residual risks, it is more convenient to break them out separately.

Under the EU-MDR, disclose all residual risks (including side effects) in the limitations, contra-indications, precautions, or warnings section of the information supplied by the manufacturer.

Use the information on side effects in the Article 88 Trend reporting.

Hi,

Could someone clarify the difference between Residual risks and side effects in the context of the MDR ? or do they mean the same ?

thanks

Good day Anon,

Concur with Dan that side effects are residual risks, but not all residual risks are side effects.  Definitely either put a "notation" of a residual risk being a side effect or potential side effect or keep a separate list somewhere in the risk summary report of side effects.  Think of residual risks as something that could happen if something was done wrong or the hazardous situation decided to pop its head up.  Whereas a side effect is usually something which can often happen with a quite small percent of the population, i.e. a good example is an allergic reaction to some material.  Also keep in mind, most medical devices do not have side effects (such as in the pharmaceutical world), though many medical devices have residual risks.

Residual risks come from EN ISO 14971:2019/A11:2021. They are the risks remaining after implementing the risk control measures.

Side effects are unintended results of using the device. Side effects are residual risks, but not all residual risks are side effects.

Because of the EU-MDR I recommend that in the risk management hazard analysis include a column for both residual risks and side effects. While side effects are residual risks, it is more convenient to break them out separately.

Under the EU-MDR, disclose all residual risks (including side effects) in the limitations, contra-indications, precautions, or warnings section of the information supplied by the manufacturer.

Use the information on side effects in the Article 88 Trend reporting.

Hi,

Could someone clarify the difference between Residual risks and side effects in the context of the MDR ? or do they mean the same ?

thanks

Hi all,

Thanks for your feedback. So, the side effects can be considered transient ? And if there are long term complications or serious injury resulting from user error or pre-existing patient conditions , these would be considered as residual risks ?

Good day Anon,

Concur with Dan that side effects are residual risks, but not all residual risks are side effects.  Definitely either put a "notation" of a residual risk being a side effect or potential side effect or keep a separate list somewhere in the risk summary report of side effects.  Think of residual risks as something that could happen if something was done wrong or the hazardous situation decided to pop its head up.  Whereas a side effect is usually something which can often happen with a quite small percent of the population, i.e. a good example is an allergic reaction to some material.  Also keep in mind, most medical devices do not have side effects (such as in the pharmaceutical world), though many medical devices have residual risks.

Residual risks come from EN ISO 14971:2019/A11:2021. They are the risks remaining after implementing the risk control measures.

Side effects are unintended results of using the device. Side effects are residual risks, but not all residual risks are side effects.

Because of the EU-MDR I recommend that in the risk management hazard analysis include a column for both residual risks and side effects. While side effects are residual risks, it is more convenient to break them out separately.

Under the EU-MDR, disclose all residual risks (including side effects) in the limitations, contra-indications, precautions, or warnings section of the information supplied by the manufacturer.

Use the information on side effects in the Article 88 Trend reporting.

Hi,

Could someone clarify the difference between Residual risks and side effects in the context of the MDR ? or do they mean the same ?

thanks

When the effect is transient or long-term does not enter into determining either some thing is a residual risk or part of the side-effect subset of residual risk.

A residual risk is a risk remaining after implementing the risk control measures. I often use the office copier as an example of residual risk. Inside is a hot fuser which is necessary for the copier to work. If you touch it, you will get a burn.

The typical risk control measures are protective measures (an interlocked cover to shut down the power) and information for safety (a label about a hot surface). However, it takes time for the fuser to cool, so there is a residual risk of a burn. Whether the burn is long-term or transient doesn't matter.

Residual risks are identified in the medical device risk management process.

A side-effect could, for example, trigger an allergy. The allergic reaction could be short term (an inflammation that passes quickly). The allergic reaction could be long term such as change in the immune system but makes a person more susceptible to allergic reactions.

There may not be a risk control measure for these kinds of side-effects, so they are also residual risks.

Hi all,

Thanks for your feedback. So, the side effects can be considered transient ? And if there are long term complications or serious injury resulting from user error or pre-existing patient conditions , these would be considered as residual risks ?

Good day Anon,

Concur with Dan that side effects are residual risks, but not all residual risks are side effects.  Definitely either put a "notation" of a residual risk being a side effect or potential side effect or keep a separate list somewhere in the risk summary report of side effects.  Think of residual risks as something that could happen if something was done wrong or the hazardous situation decided to pop its head up.  Whereas a side effect is usually something which can often happen with a quite small percent of the population, i.e. a good example is an allergic reaction to some material.  Also keep in mind, most medical devices do not have side effects (such as in the pharmaceutical world), though many medical devices have residual risks.

Residual risks come from EN ISO 14971:2019/A11:2021. They are the risks remaining after implementing the risk control measures.

Side effects are unintended results of using the device. Side effects are residual risks, but not all residual risks are side effects.

Because of the EU-MDR I recommend that in the risk management hazard analysis include a column for both residual risks and side effects. While side effects are residual risks, it is more convenient to break them out separately.

Under the EU-MDR, disclose all residual risks (including side effects) in the limitations, contra-indications, precautions, or warnings section of the information supplied by the manufacturer.

Use the information on side effects in the Article 88 Trend reporting.

Hi,

Could someone clarify the difference between Residual risks and side effects in the context of the MDR ? or do they mean the same ?

thanks

In the risk assessment , what would be the verification of implementation and verification of effectiveness for the residual risks /side effects ?

When the effect is transient or long-term does not enter into determining either some thing is a residual risk or part of the side-effect subset of residual risk.

A residual risk is a risk remaining after implementing the risk control measures. I often use the office copier as an example of residual risk. Inside is a hot fuser which is necessary for the copier to work. If you touch it, you will get a burn.

The typical risk control measures are protective measures (an interlocked cover to shut down the power) and information for safety (a label about a hot surface). However, it takes time for the fuser to cool, so there is a residual risk of a burn. Whether the burn is long-term or transient doesn't matter.

Residual risks are identified in the medical device risk management process.

A side-effect could, for example, trigger an allergy. The allergic reaction could be short term (an inflammation that passes quickly). The allergic reaction could be long term such as change in the immune system but makes a person more susceptible to allergic reactions.

There may not be a risk control measure for these kinds of side-effects, so they are also residual risks.

Hi all,

Thanks for your feedback. So, the side effects can be considered transient ? And if there are long term complications or serious injury resulting from user error or pre-existing patient conditions , these would be considered as residual risks ?

Good day Anon,

Concur with Dan that side effects are residual risks, but not all residual risks are side effects.  Definitely either put a "notation" of a residual risk being a side effect or potential side effect or keep a separate list somewhere in the risk summary report of side effects.  Think of residual risks as something that could happen if something was done wrong or the hazardous situation decided to pop its head up.  Whereas a side effect is usually something which can often happen with a quite small percent of the population, i.e. a good example is an allergic reaction to some material.  Also keep in mind, most medical devices do not have side effects (such as in the pharmaceutical world), though many medical devices have residual risks.

Residual risks come from EN ISO 14971:2019/A11:2021. They are the risks remaining after implementing the risk control measures.

Side effects are unintended results of using the device. Side effects are residual risks, but not all residual risks are side effects.

Because of the EU-MDR I recommend that in the risk management hazard analysis include a column for both residual risks and side effects. While side effects are residual risks, it is more convenient to break them out separately.

Under the EU-MDR, disclose all residual risks (including side effects) in the limitations, contra-indications, precautions, or warnings section of the information supplied by the manufacturer.

Use the information on side effects in the Article 88 Trend reporting.

Hi,

Could someone clarify the difference between Residual risks and side effects in the context of the MDR ? or do they mean the same ?

thanks

In the risk assessment , what would be the verification of implementation and verification of effectiveness for the residual risks /side effects ?

When the effect is transient or long-term does not enter into determining either some thing is a residual risk or part of the side-effect subset of residual risk.

A residual risk is a risk remaining after implementing the risk control measures. I often use the office copier as an example of residual risk. Inside is a hot fuser which is necessary for the copier to work. If you touch it, you will get a burn.

The typical risk control measures are protective measures (an interlocked cover to shut down the power) and information for safety (a label about a hot surface). However, it takes time for the fuser to cool, so there is a residual risk of a burn. Whether the burn is long-term or transient doesn't matter.

Residual risks are identified in the medical device risk management process.

A side-effect could, for example, trigger an allergy. The allergic reaction could be short term (an inflammation that passes quickly). The allergic reaction could be long term such as change in the immune system but makes a person more susceptible to allergic reactions.

There may not be a risk control measure for these kinds of side-effects, so they are also residual risks.

Hi all,

Thanks for your feedback. So, the side effects can be considered transient ? And if there are long term complications or serious injury resulting from user error or pre-existing patient conditions , these would be considered as residual risks ?

Good day Anon,

Concur with Dan that side effects are residual risks, but not all residual risks are side effects.  Definitely either put a "notation" of a residual risk being a side effect or potential side effect or keep a separate list somewhere in the risk summary report of side effects.  Think of residual risks as something that could happen if something was done wrong or the hazardous situation decided to pop its head up.  Whereas a side effect is usually something which can often happen with a quite small percent of the population, i.e. a good example is an allergic reaction to some material.  Also keep in mind, most medical devices do not have side effects (such as in the pharmaceutical world), though many medical devices have residual risks.

Residual risks come from EN ISO 14971:2019/A11:2021. They are the risks remaining after implementing the risk control measures.

Side effects are unintended results of using the device. Side effects are residual risks, but not all residual risks are side effects.

Because of the EU-MDR I recommend that in the risk management hazard analysis include a column for both residual risks and side effects. While side effects are residual risks, it is more convenient to break them out separately.

Under the EU-MDR, disclose all residual risks (including side effects) in the limitations, contra-indications, precautions, or warnings section of the information supplied by the manufacturer.

Use the information on side effects in the Article 88 Trend reporting.

Hi,

Could someone clarify the difference between Residual risks and side effects in the context of the MDR ? or do they mean the same ?

thanks

Implementation verification and effectiveness verification don't apply to residual risks /side effects. They apply to the risk control measures.

Residual risks /side effects are the risk remaining after implementing the risk control measures.

In the risk assessment , what would be the verification of implementation and verification of effectiveness for the residual risks /side effects ?

When the effect is transient or long-term does not enter into determining either some thing is a residual risk or part of the side-effect subset of residual risk.

A residual risk is a risk remaining after implementing the risk control measures. I often use the office copier as an example of residual risk. Inside is a hot fuser which is necessary for the copier to work. If you touch it, you will get a burn.

The typical risk control measures are protective measures (an interlocked cover to shut down the power) and information for safety (a label about a hot surface). However, it takes time for the fuser to cool, so there is a residual risk of a burn. Whether the burn is long-term or transient doesn't matter.

Residual risks are identified in the medical device risk management process.

A side-effect could, for example, trigger an allergy. The allergic reaction could be short term (an inflammation that passes quickly). The allergic reaction could be long term such as change in the immune system but makes a person more susceptible to allergic reactions.

There may not be a risk control measure for these kinds of side-effects, so they are also residual risks.

Hi all,

Thanks for your feedback. So, the side effects can be considered transient ? And if there are long term complications or serious injury resulting from user error or pre-existing patient conditions , these would be considered as residual risks ?

Good day Anon,

Concur with Dan that side effects are residual risks, but not all residual risks are side effects.  Definitely either put a "notation" of a residual risk being a side effect or potential side effect or keep a separate list somewhere in the risk summary report of side effects.  Think of residual risks as something that could happen if something was done wrong or the hazardous situation decided to pop its head up.  Whereas a side effect is usually something which can often happen with a quite small percent of the population, i.e. a good example is an allergic reaction to some material.  Also keep in mind, most medical devices do not have side effects (such as in the pharmaceutical world), though many medical devices have residual risks.

Residual risks come from EN ISO 14971:2019/A11:2021. They are the risks remaining after implementing the risk control measures.

Side effects are unintended results of using the device. Side effects are residual risks, but not all residual risks are side effects.

Because of the EU-MDR I recommend that in the risk management hazard analysis include a column for both residual risks and side effects. While side effects are residual risks, it is more convenient to break them out separately.

Under the EU-MDR, disclose all residual risks (including side effects) in the limitations, contra-indications, precautions, or warnings section of the information supplied by the manufacturer.

Use the information on side effects in the Article 88 Trend reporting.

Hi,

Could someone clarify the difference between Residual risks and side effects in the context of the MDR ? or do they mean the same ?

thanks

Hi,

Could someone clarify the difference between Residual risks and side effects in the context of the MDR ? or do they mean the same ?

thanks

To add what may hopefully a useful differentiator....

As other replies have said, residual risks are what is left after risk controls have been implemented. 

Side effects are a sub-set of the residual risks. More often than not, I would argue that side-effects occur in NORMAL conditions rather than FAULT conditions. E.g. a sore-throat or cough after being intubated with a endotracheal tube for a period of time and there has been no failure of the tube during insertion, use or removal. There is also an connection between these side-effects and the residual risks that should be disclosed to the user/patient. i.e. side-effects should (always) be part of the disclosure of residual risks (as in most cases, I think Richard indicated this too in this reply, there will be no risk control measures).

I will happily hear (and learn from) any exceptions to my quickly written 'rules' that anyone can share. 

Hi,

Could someone clarify the difference between Residual risks and side effects in the context of the MDR ? or do they mean the same ?

thanks

Great points, Ed. And pointing out that Side Effects occur during Normal Condition is a valuable add to the discussion. 

------------------------------
Edwin Bills
Edwin Bills Consultant
ASQ Fellow CQE, CQA, CQM/OE, RAPS RAC
elb@edwinbillsconsultant.com

Original Message:
Sent: 05-Sep-2023 06:28
From: Edward Ball
Subject: Residual risks vs side effects

To add what may hopefully a useful differentiator....

As other replies have said, residual risks are what is left after risk controls have been implemented. 

Side effects are a sub-set of the residual risks. More often than not, I would argue that side-effects occur in NORMAL conditions rather than FAULT conditions. E.g. a sore-throat or cough after being intubated with a endotracheal tube for a period of time and there has been no failure of the tube during insertion, use or removal. There is also an connection between these side-effects and the residual risks that should be disclosed to the user/patient. i.e. side-effects should (always) be part of the disclosure of residual risks (as in most cases, I think Richard indicated this too in this reply, there will be no risk control measures).

I will happily hear (and learn from) any exceptions to my quickly written 'rules' that anyone can share. 

------------------------------
Ed Ball
Manager, Intelligence & Innovation
United Kingdom

Original Message:
Sent: 27-Aug-2023 18:53
From: Anonymous Member
Subject: Residual risks vs side effects

This message was posted by a user wishing to remain anonymous

Hi,

Could someone clarify the difference between Residual risks and side effects in the context of the MDR ? or do they mean the same ?

thanks

Please apologize my poking as I don't want to correct the experts here, but in my understanding, risks can occur from a foreseeable misuse, from failed functionality, or from the device characteristics. Only one of those is based on a failure. All three might need to be mitigated, potentially resulting in residual risks.

Is then the distinction that a side effect occurs only during a foreseeable misuse or from device characteristics?

And if so, shouldn't it be listed as a residual risk?

------------------------------
Richard Jansky
Head of RA / RM / QM
Beringen
Switzerland

Original Message:
Sent: 05-Sep-2023 08:34
From: Edwin Bills
Subject: Residual risks vs side effects

Great points, Ed. And pointing out that Side Effects occur during Normal Condition is a valuable add to the discussion. 

------------------------------
Edwin Bills
Edwin Bills Consultant
ASQ Fellow CQE, CQA, CQM/OE, RAPS RAC
elb@edwinbillsconsultant.com

Original Message:
Sent: 05-Sep-2023 06:28
From: Edward Ball
Subject: Residual risks vs side effects

To add what may hopefully a useful differentiator....

As other replies have said, residual risks are what is left after risk controls have been implemented. 

Side effects are a sub-set of the residual risks. More often than not, I would argue that side-effects occur in NORMAL conditions rather than FAULT conditions. E.g. a sore-throat or cough after being intubated with a endotracheal tube for a period of time and there has been no failure of the tube during insertion, use or removal. There is also an connection between these side-effects and the residual risks that should be disclosed to the user/patient. i.e. side-effects should (always) be part of the disclosure of residual risks (as in most cases, I think Richard indicated this too in this reply, there will be no risk control measures).

I will happily hear (and learn from) any exceptions to my quickly written 'rules' that anyone can share. 

------------------------------
Ed Ball
Manager, Intelligence & Innovation
United Kingdom

Original Message:
Sent: 27-Aug-2023 18:53
From: Anonymous Member
Subject: Residual risks vs side effects

This message was posted by a user wishing to remain anonymous

Hi,

Could someone clarify the difference between Residual risks and side effects in the context of the MDR ? or do they mean the same ?

thanks

Please apologize my poking as I don't want to correct the experts here, but in my understanding, risks can occur from a foreseeable misuse, from failed functionality, or from the device characteristics. Only one of those is based on a failure. All three might need to be mitigated, potentially resulting in residual risks.

Is then the distinction that a side effect occurs only during a foreseeable misuse or from device characteristics?

And if so, shouldn't it be listed as a residual risk?

------------------------------
Richard Jansky
Head of RA / RM / QM
Beringen
Switzerland

Original Message:
Sent: 05-Sep-2023 08:34
From: Edwin Bills
Subject: Residual risks vs side effects

Great points, Ed. And pointing out that Side Effects occur during Normal Condition is a valuable add to the discussion. 

------------------------------
Edwin Bills
Edwin Bills Consultant
ASQ Fellow CQE, CQA, CQM/OE, RAPS RAC
elb@edwinbillsconsultant.com

Original Message:
Sent: 05-Sep-2023 06:28
From: Edward Ball
Subject: Residual risks vs side effects

To add what may hopefully a useful differentiator....

As other replies have said, residual risks are what is left after risk controls have been implemented. 

Side effects are a sub-set of the residual risks. More often than not, I would argue that side-effects occur in NORMAL conditions rather than FAULT conditions. E.g. a sore-throat or cough after being intubated with a endotracheal tube for a period of time and there has been no failure of the tube during insertion, use or removal. There is also an connection between these side-effects and the residual risks that should be disclosed to the user/patient. i.e. side-effects should (always) be part of the disclosure of residual risks (as in most cases, I think Richard indicated this too in this reply, there will be no risk control measures).

I will happily hear (and learn from) any exceptions to my quickly written 'rules' that anyone can share. 

------------------------------
Ed Ball
Manager, Intelligence & Innovation
United Kingdom

Original Message:
Sent: 27-Aug-2023 18:53
From: Anonymous Member
Subject: Residual risks vs side effects

This message was posted by a user wishing to remain anonymous

Hi,

Could someone clarify the difference between Residual risks and side effects in the context of the MDR ? or do they mean the same ?

thanks

Hi Richard

I think Dan has confirmed the latter part of your question already, in that side effects are a sub-set of the residual risks. My suggestion was that side-effects would typically only stem from NORMAL USE conditions, which would mean no fault conditions (I would interpret that as the device is manufactured to specification, used as intended and does not fail during use etc). Which is what I think you are meaning by 'device characteristics'. 

Please apologize my poking as I don't want to correct the experts here, but in my understanding, risks can occur from a foreseeable misuse, from failed functionality, or from the device characteristics. Only one of those is based on a failure. All three might need to be mitigated, potentially resulting in residual risks.

Is then the distinction that a side effect occurs only during a foreseeable misuse or from device characteristics?

And if so, shouldn't it be listed as a residual risk?

------------------------------
Richard Jansky
Head of RA / RM / QM
Beringen
Switzerland

Original Message:
Sent: 05-Sep-2023 08:34
From: Edwin Bills
Subject: Residual risks vs side effects

Great points, Ed. And pointing out that Side Effects occur during Normal Condition is a valuable add to the discussion. 

------------------------------
Edwin Bills
Edwin Bills Consultant
ASQ Fellow CQE, CQA, CQM/OE, RAPS RAC
elb@edwinbillsconsultant.com

Original Message:
Sent: 05-Sep-2023 06:28
From: Edward Ball
Subject: Residual risks vs side effects

To add what may hopefully a useful differentiator....

As other replies have said, residual risks are what is left after risk controls have been implemented. 

Side effects are a sub-set of the residual risks. More often than not, I would argue that side-effects occur in NORMAL conditions rather than FAULT conditions. E.g. a sore-throat or cough after being intubated with a endotracheal tube for a period of time and there has been no failure of the tube during insertion, use or removal. There is also an connection between these side-effects and the residual risks that should be disclosed to the user/patient. i.e. side-effects should (always) be part of the disclosure of residual risks (as in most cases, I think Richard indicated this too in this reply, there will be no risk control measures).

I will happily hear (and learn from) any exceptions to my quickly written 'rules' that anyone can share. 

------------------------------
Ed Ball
Manager, Intelligence & Innovation
United Kingdom

Original Message:
Sent: 27-Aug-2023 18:53
From: Anonymous Member
Subject: Residual risks vs side effects

This message was posted by a user wishing to remain anonymous

Hi,

Could someone clarify the difference between Residual risks and side effects in the context of the MDR ? or do they mean the same ?

thanks

Thank you Dan and Ed for your helpful responses.

Yes, I didn't mean to say mitigation, but reduction - my bad.

Also yes, risks from "device characteristics" as "functionality/performance needed to achieve intended use" I see as those associated with the device functioning as specified and used as intended.

If the distinction is as fuzzy as it seems, is there a need to distinguish between residual risk and side effect?

Based on the MDR, it seems that one knows the residual risks prior to going into the Clinical Evaluation. There, one confirms them and determines any undesirable side-effect not thought of, which become subsequently residual risks as well.

Presently though, I feel it's rather semantics.

Hi Richard

I think Dan has confirmed the latter part of your question already, in that side effects are a sub-set of the residual risks. My suggestion was that side-effects would typically only stem from NORMAL USE conditions, which would mean no fault conditions (I would interpret that as the device is manufactured to specification, used as intended and does not fail during use etc). Which is what I think you are meaning by 'device characteristics'. 

Please apologize my poking as I don't want to correct the experts here, but in my understanding, risks can occur from a foreseeable misuse, from failed functionality, or from the device characteristics. Only one of those is based on a failure. All three might need to be mitigated, potentially resulting in residual risks.

Is then the distinction that a side effect occurs only during a foreseeable misuse or from device characteristics?

And if so, shouldn't it be listed as a residual risk?

------------------------------
Richard Jansky
Head of RA / RM / QM
Beringen
Switzerland

Original Message:
Sent: 05-Sep-2023 08:34
From: Edwin Bills
Subject: Residual risks vs side effects

Great points, Ed. And pointing out that Side Effects occur during Normal Condition is a valuable add to the discussion. 

------------------------------
Edwin Bills
Edwin Bills Consultant
ASQ Fellow CQE, CQA, CQM/OE, RAPS RAC
elb@edwinbillsconsultant.com

Original Message:
Sent: 05-Sep-2023 06:28
From: Edward Ball
Subject: Residual risks vs side effects

To add what may hopefully a useful differentiator....

As other replies have said, residual risks are what is left after risk controls have been implemented. 

Side effects are a sub-set of the residual risks. More often than not, I would argue that side-effects occur in NORMAL conditions rather than FAULT conditions. E.g. a sore-throat or cough after being intubated with a endotracheal tube for a period of time and there has been no failure of the tube during insertion, use or removal. There is also an connection between these side-effects and the residual risks that should be disclosed to the user/patient. i.e. side-effects should (always) be part of the disclosure of residual risks (as in most cases, I think Richard indicated this too in this reply, there will be no risk control measures).

I will happily hear (and learn from) any exceptions to my quickly written 'rules' that anyone can share. 

------------------------------
Ed Ball
Manager, Intelligence & Innovation
United Kingdom

Original Message:
Sent: 27-Aug-2023 18:53
From: Anonymous Member
Subject: Residual risks vs side effects

This message was posted by a user wishing to remain anonymous

Hi,

Could someone clarify the difference between Residual risks and side effects in the context of the MDR ? or do they mean the same ?

thanks

Hi,

Could someone clarify the difference between Residual risks and side effects in the context of the MDR ? or do they mean the same ?

thanks