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From EU perspective information (i.e. labeling risk controls) should not be attributed to risk reduction.

Does it apply to user training as well?  (under the assumption I can measure training effectiveness)

In the ISO standard 14971 - 7.1 Risk Control Option Analysis (c) - Infomation for safety and, where appropriate, training to users are written together. 

From EU perspective information (i.e. labeling risk controls) should not be attributed to risk reduction.

Does it apply to user training as well?  (under the assumption I can measure training effectiveness)

In the ISO standard 14971 - 7.1 Risk Control Option Analysis (c) - Infomation for safety and, where appropriate, training to users are written together. 

From EU perspective information (i.e. labeling risk controls) should not be attributed to risk reduction.

Does it apply to user training as well?  (under the assumption I can measure training effectiveness)

In the ISO standard 14971 - 7.1 Risk Control Option Analysis (c) - Infomation for safety and, where appropriate, training to users are written together. 

From EU perspective information (i.e. labeling risk controls) should not be attributed to risk reduction.

Does it apply to user training as well?  (under the assumption I can measure training effectiveness)

In the ISO standard 14971 - 7.1 Risk Control Option Analysis (c) - Infomation for safety and, where appropriate, training to users are written together. 

The reason your files have been approved is that the statement in the original question is incorrect. The MDR and IVDR in GSPR 4 state that IFU is an acceptable method of risk control. This section also applies the option order of preference. So just don't jump to putting in IFU as the risk control before you can rationalize, preferably in written form, that design or precautions (options 1 and 2) are not possible.

Be aware that all risk controls must be verified for effectiveness, which in the case of IFU, if done with Usability Validation and is not as easy as it may look. 

Also, for legal reasons, your risk controls may include Warnings and (Pre)Cautions in the IFU, regardless of the use of Design and Preventive Measures also being used in your product. 

From EU perspective information (i.e. labeling risk controls) should not be attributed to risk reduction.

Does it apply to user training as well?  (under the assumption I can measure training effectiveness)

In the ISO standard 14971 - 7.1 Risk Control Option Analysis (c) - Infomation for safety and, where appropriate, training to users are written together. 

The reason your files have been approved is that the statement in the original question is incorrect. The MDR and IVDR in GSPR 4 state that IFU is an acceptable method of risk control. This section also applies the option order of preference. So just don't jump to putting in IFU as the risk control before you can rationalize, preferably in written form, that design or precautions (options 1 and 2) are not possible.

Be aware that all risk controls must be verified for effectiveness, which in the case of IFU, if done with Usability Validation and is not as easy as it may look.

Also, for legal reasons, your risk controls may include Warnings and (Pre)Cautions in the IFU, regardless of the use of Design and Preventive Measures also being used in your product. 

From EU perspective information (i.e. labeling risk controls) should not be attributed to risk reduction.

Does it apply to user training as well?  (under the assumption I can measure training effectiveness)

In the ISO standard 14971 - 7.1 Risk Control Option Analysis (c) - Infomation for safety and, where appropriate, training to users are written together. 

A review by "experts" does not meet the requirement of ISO 14971 if you are claiming that Instructions for Use (which also includes training) reduces the risk.  You must Verify the Effectiveness (14971:2019 Clause 7.2-See Notes 2 and 3, Also Annex A.2.7.2; See also  ISO TR 24971:2020 7.2) of the Risk Control which is usually done, in the case of Instructions for Use, during Design Validation using the techniques in Usability Engineering.  This provides data supporting the estimated reduction of the risk.  Techniques for Verification of Effectiveness of IFU are similar to other Design Validation activities where actual users are given the product as shipped and they are to use it, and are observed to see how they use the IFU and if they get the proper results.  

The reason your files have been approved is that the statement in the original question is incorrect. The MDR and IVDR in GSPR 4 state that IFU is an acceptable method of risk control. This section also applies the option order of preference. So just don't jump to putting in IFU as the risk control before you can rationalize, preferably in written form, that design or precautions (options 1 and 2) are not possible.

Be aware that all risk controls must be verified for effectiveness, which in the case of IFU, if done with Usability Validation and is not as easy as it may look.

Also, for legal reasons, your risk controls may include Warnings and (Pre)Cautions in the IFU, regardless of the use of Design and Preventive Measures also being used in your product. 

From EU perspective information (i.e. labeling risk controls) should not be attributed to risk reduction.

Does it apply to user training as well?  (under the assumption I can measure training effectiveness)

In the ISO standard 14971 - 7.1 Risk Control Option Analysis (c) - Infomation for safety and, where appropriate, training to users are written together. 

A review by "experts" does not meet the requirement of ISO 14971 if you are claiming that Instructions for Use (which also includes training) reduces the risk.  You must Verify the Effectiveness (14971:2019 Clause 7.2-See Notes 2 and 3, Also Annex A.2.7.2; See also  ISO TR 24971:2020 7.2) of the Risk Control which is usually done, in the case of Instructions for Use, during Design Validation using the techniques in Usability Engineering.  This provides data supporting the estimated reduction of the risk.  Techniques for Verification of Effectiveness of IFU are similar to other Design Validation activities where actual users are given the product as shipped and they are to use it, and are observed to see how they use the IFU and if they get the proper results.  

The reason your files have been approved is that the statement in the original question is incorrect. The MDR and IVDR in GSPR 4 state that IFU is an acceptable method of risk control. This section also applies the option order of preference. So just don't jump to putting in IFU as the risk control before you can rationalize, preferably in written form, that design or precautions (options 1 and 2) are not possible.

Be aware that all risk controls must be verified for effectiveness, which in the case of IFU, if done with Usability Validation and is not as easy as it may look.

Also, for legal reasons, your risk controls may include Warnings and (Pre)Cautions in the IFU, regardless of the use of Design and Preventive Measures also being used in your product. 

From EU perspective information (i.e. labeling risk controls) should not be attributed to risk reduction.

Does it apply to user training as well?  (under the assumption I can measure training effectiveness)

In the ISO standard 14971 - 7.1 Risk Control Option Analysis (c) - Infomation for safety and, where appropriate, training to users are written together. 

From EU perspective information (i.e. labeling risk controls) should not be attributed to risk reduction.

Does it apply to user training as well?  (under the assumption I can measure training effectiveness)

In the ISO standard 14971 - 7.1 Risk Control Option Analysis (c) - Infomation for safety and, where appropriate, training to users are written together. 

Hi,

In case if training is used as risk reduction, effectiveness has to be validated by usability study.

Information for safety to be included in the IFU and IFU should be used in the usability study to show that it was effective.

From EU perspective information (i.e. labeling risk controls) should not be attributed to risk reduction.

Does it apply to user training as well?  (under the assumption I can measure training effectiveness)

In the ISO standard 14971 - 7.1 Risk Control Option Analysis (c) - Infomation for safety and, where appropriate, training to users are written together.