Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear group,

I would like to benchmark with you on how you are implementing the requirement of adding warnings to the label vs the european languages required. Do you now if its acceptable to add general warnings to the product label in English and have them translated to all required languages in the DFU/IFU?

Thanks for sharing your experience!

Regards

Yes, it is completely acceptable.  Per the MDR 2017/745 Chapter III, 23.2 (m), " warnings or precautions to be taken that need to be brought to the immediate attention of the user of the device, and to any other person. This information may be kept to a minimum in which case more detailed information shall appear in the instructions for use, taking into account the intended users; "

------------------------------
Phani Puppala
Franklin MA
United States
------------------------------

Original Message:
Sent: 22-Jan-2019 11:29
From: Anonymous Member
Subject: Labeling changes per MDR

This message was posted by a user wishing to remain anonymous

Dear group,

I would like to benchmark with you on how you are implementing the requirement of adding warnings to the label vs the <g class="gr_ gr_29 gr-alert gr_spell gr_inline_cards gr_run_anim ContextualSpelling ins-del multiReplace" id="29" data-gr-id="29">european</g> languages required. Do you <g class="gr_ gr_28 gr-alert gr_spell gr_inline_cards gr_run_anim ContextualSpelling ins-del" id="28" data-gr-id="28">now</g> if <g class="gr_ gr_35 gr-alert gr_spell gr_inline_cards gr_run_anim ContextualSpelling multiReplace" id="35" data-gr-id="35">its</g> acceptable to add general warnings to the product label in English and have them translated to all required languages in the DFU/IFU?

Thanks for sharing your experience!

Regards

Since the MDR allows warnings or precautions to be taken that need to be brought to
the immediate attention of the user of the device, and to any other
person to be kept to a minimum on the label, I would recommend applying the symbols from ISO 15223-1:2016

'Consult instructions for use'
This Indicates the need for the user to consult the instructions for use

and probably even

'Caution' 
This Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself.

------------------------------
Dr. Stefan Menzl
Geschäftsführer / Executive Director
Qserve Group Deutschland GmbH
+49 152 900 28156
stefan.menzl@qservegroup.com
------------------------------

Original Message:
Sent: 22-Jan-2019 16:28
From: Phani Puppala
Subject: Labeling changes per MDR

Yes, it is completely acceptable.  Per the MDR 2017/745 Chapter III, 23.2 (m), " warnings or precautions to be taken that need to be brought to the immediate attention of the user of the device, and to any other person. This information may be kept to a minimum in which case more detailed information shall appear in the instructions for use, taking into account the intended users; "

------------------------------
Phani Puppala
Franklin MA
United States

Original Message:
Sent: 22-Jan-2019 11:29
From: Anonymous Member
Subject: Labeling changes per MDR

This message was posted by a user wishing to remain anonymous

Dear group,

I would like to benchmark with you on how you are implementing the requirement of adding warnings to the label vs the <g class="gr_ gr_29 gr-alert gr_spell gr_inline_cards gr_run_anim ContextualSpelling ins-del multiReplace" id="29" data-gr-id="29">european</g> languages required. Do you <g class="gr_ gr_28 gr-alert gr_spell gr_inline_cards gr_run_anim ContextualSpelling ins-del" id="28" data-gr-id="28">now</g> if <g class="gr_ gr_35 gr-alert gr_spell gr_inline_cards gr_run_anim ContextualSpelling multiReplace" id="35" data-gr-id="35">its</g> acceptable to add general warnings to the product label in English and have them translated to all required languages in the DFU/IFU?

Thanks for sharing your experience!

Regards

As you can imagine putting all Contraindications, Warnings, Cautions on the direct device labelling may not be feasible due to size of label.  As Stefan commented the symbol for referring to Warning/Caution statements in IFU and reference to IFU should be on the direct label in prominence.  It would be expected that all Contraindications, Warnings, Cautions, Precautions, etc. are then clearly identified in the IFU (by section) and verified translation so there is no confusing on the warnings or caution statements.  This is going to be highly more scrutinised under the EU MDR because of linkage to risk management.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 23-Jan-2019 04:08
From: Stefan Menzl
Subject: Labeling changes per MDR

Since the MDR allows warnings or precautions to be taken that need to be brought to
the immediate attention of the user of the device, and to any other
person to be kept to a minimum on the label, I would recommend applying the symbols from ISO 15223-1:2016

'Consult instructions for use'
This Indicates the need for the user to consult the instructions for use

and probably even

'Caution'
This Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself.

------------------------------
Dr. Stefan Menzl
Geschäftsführer / Executive Director
Qserve Group Deutschland GmbH
+49 152 900 28156
stefan.menzl@qservegroup.com

Original Message:
Sent: 22-Jan-2019 16:28
From: Phani Puppala
Subject: Labeling changes per MDR

Yes, it is completely acceptable.  Per the MDR 2017/745 Chapter III, 23.2 (m), " warnings or precautions to be taken that need to be brought to the immediate attention of the user of the device, and to any other person. This information may be kept to a minimum in which case more detailed information shall appear in the instructions for use, taking into account the intended users; "

------------------------------
Phani Puppala
Franklin MA
United States

Original Message:
Sent: 22-Jan-2019 11:29
From: Anonymous Member
Subject: Labeling changes per MDR

This message was posted by a user wishing to remain anonymous

Dear group,

I would like to benchmark with you on how you are implementing the requirement of adding warnings to the label vs the <g class="gr_ gr_29 gr-alert gr_spell gr_inline_cards gr_run_anim ContextualSpelling ins-del multiReplace" id="29" data-gr-id="29">european</g> languages required. Do you <g class="gr_ gr_28 gr-alert gr_spell gr_inline_cards gr_run_anim ContextualSpelling ins-del" id="28" data-gr-id="28">now</g> if <g class="gr_ gr_35 gr-alert gr_spell gr_inline_cards gr_run_anim ContextualSpelling multiReplace" id="35" data-gr-id="35">its</g> acceptable to add general warnings to the product label in English and have them translated to all required languages in the DFU/IFU?

Thanks for sharing your experience!

Regards

This message was posted by a user wishing to remain anonymous

Dear all,

Thanks for your responses, makes a lot of sense, however should you have to indicate something, would you just use English, and all translations of warnings and contraindications be translated in the DFU?

Best regards and thanks again for your help.
Original Message:
Sent: 23-Jan-2019 06:59
From: Richard Vincins
Subject: Labeling changes per MDR

As you can imagine putting all Contraindications, Warnings, Cautions on the direct device labelling may not be feasible due to size of label.  As Stefan commented the symbol for referring to Warning/Caution statements in IFU and reference to IFU should be on the direct label in prominence.  It would be expected that all Contraindications, Warnings, Cautions, Precautions, etc. are then clearly identified in the IFU (by section) and verified translation so there is no confusing on the warnings or caution statements.  This is going to be highly more scrutinised under the EU MDR because of linkage to risk management.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 23-Jan-2019 04:08
From: Stefan Menzl
Subject: Labeling changes per MDR

Since the MDR allows warnings or precautions to be taken that need to be brought to
the immediate attention of the user of the device, and to any other
person to be kept to a minimum on the label, I would recommend applying the symbols from ISO 15223-1:2016

'Consult instructions for use'
This Indicates the need for the user to consult the instructions for use

and probably even

'Caution'
This Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself.

------------------------------
Dr. Stefan Menzl
Geschäftsführer / Executive Director
Qserve Group Deutschland GmbH
+49 152 900 28156
stefan.menzl@qservegroup.com

Original Message:
Sent: 22-Jan-2019 16:28
From: Phani Puppala
Subject: Labeling changes per MDR

Yes, it is completely acceptable.  Per the MDR 2017/745 Chapter III, 23.2 (m), " warnings or precautions to be taken that need to be brought to the immediate attention of the user of the device, and to any other person. This information may be kept to a minimum in which case more detailed information shall appear in the instructions for use, taking into account the intended users; "

------------------------------
Phani Puppala
Franklin MA
United States

Original Message:
Sent: 22-Jan-2019 11:29
From: Anonymous Member
Subject: Labeling changes per MDR

This message was posted by a user wishing to remain anonymous

Dear group,

I would like to benchmark with you on how you are implementing the requirement of adding warnings to the label vs the <g class="gr_ gr_29 gr-alert gr_spell gr_inline_cards gr_run_anim ContextualSpelling ins-del multiReplace" id="29" data-gr-id="29">european</g> languages required. Do you <g class="gr_ gr_28 gr-alert gr_spell gr_inline_cards gr_run_anim ContextualSpelling ins-del" id="28" data-gr-id="28">now</g> if <g class="gr_ gr_35 gr-alert gr_spell gr_inline_cards gr_run_anim ContextualSpelling multiReplace" id="35" data-gr-id="35">its</g> acceptable to add general warnings to the product label in English and have them translated to all required languages in the DFU/IFU?

Thanks for sharing your experience!

Regards

That might depend on why you "have to" indicate something. If you are putting some information there to reduce the probability of harm​, you have to consider if you can meet that goal for all users with just one language.

------------------------------
Anne LeBlanc
Manager, Regulatory Affairs
United States
------------------------------

Original Message:
Sent: 25-Jan-2019 16:04
From: Anonymous Member
Subject: Labeling changes per MDR

This message was posted by a user wishing to remain anonymous

Dear all,

Thanks for your responses, makes a lot of sense, however should you have to indicate something, would you just use English, and all translations of warnings and contraindications be translated in the DFU?

Best regards and thanks again for your help.
Original Message:
Sent: 23-Jan-2019 06:59
From: Richard Vincins
Subject: Labeling changes per MDR

As you can imagine putting all Contraindications, Warnings, Cautions on the direct device labelling may not be feasible due to size of label.  As Stefan commented the symbol for referring to Warning/Caution statements in IFU and reference to IFU should be on the direct label in prominence.  It would be expected that all Contraindications, Warnings, Cautions, Precautions, etc. are then clearly identified in the IFU (by section) and verified translation so there is no confusing on the warnings or caution statements.  This is going to be highly more scrutinised under the EU MDR because of linkage to risk management.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 23-Jan-2019 04:08
From: Stefan Menzl
Subject: Labeling changes per MDR

Since the MDR allows warnings or precautions to be taken that need to be brought to
the immediate attention of the user of the device, and to any other
person to be kept to a minimum on the label, I would recommend applying the symbols from ISO 15223-1:2016

'Consult instructions for use'
This Indicates the need for the user to consult the instructions for use

and probably even

'Caution'
This Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself.

------------------------------
Dr. Stefan Menzl
Geschäftsführer / Executive Director
Qserve Group Deutschland GmbH
+49 152 900 28156
stefan.menzl@qservegroup.com

Original Message:
Sent: 22-Jan-2019 16:28
From: Phani Puppala
Subject: Labeling changes per MDR

Yes, it is completely acceptable.  Per the MDR 2017/745 Chapter III, 23.2 (m), " warnings or precautions to be taken that need to be brought to the immediate attention of the user of the device, and to any other person. This information may be kept to a minimum in which case more detailed information shall appear in the instructions for use, taking into account the intended users; "

------------------------------
Phani Puppala
Franklin MA
United States

Original Message:
Sent: 22-Jan-2019 11:29
From: Anonymous Member
Subject: Labeling changes per MDR

This message was posted by a user wishing to remain anonymous

Dear group,

I would like to benchmark with you on how you are implementing the requirement of adding warnings to the label vs the <g class="gr_ gr_29 gr-alert gr_spell gr_inline_cards gr_run_anim ContextualSpelling ins-del multiReplace" id="29" data-gr-id="29">european</g> languages required. Do you <g class="gr_ gr_28 gr-alert gr_spell gr_inline_cards gr_run_anim ContextualSpelling ins-del" id="28" data-gr-id="28">now</g> if <g class="gr_ gr_35 gr-alert gr_spell gr_inline_cards gr_run_anim ContextualSpelling multiReplace" id="35" data-gr-id="35">its</g> acceptable to add general warnings to the product label in English and have them translated to all required languages in the DFU/IFU?

Thanks for sharing your experience!

Regards

Putting all Contraindications, Warnings, Cautions on the direct device labelling may not be feasible due to size of label.
Putting into IFU  all Contraindications, Warnings, Caution  is possible but please take into consideration  the  Risk Management standard ISO 14971 which requried to verify  such information  from point of  users view , furthermore must not  confuse  the users with a lot of safety information (warnings,side effects, symbols..) 

Regards
Evangelos
Consultant/lLead auditor LRQA

------------------------------
Evangelos Tavandzis
Praha
Czech Republic
------------------------------

Original Message:
Sent: 22-Jan-2019 11:29
From: Anonymous Member
Subject: Labeling changes per MDR

This message was posted by a user wishing to remain anonymous

Dear group,

I would like to benchmark with you on how you are implementing the requirement of adding warnings to the label vs the european languages required. Do you now if its acceptable to add general warnings to the product label in English and have them translated to all required languages in the DFU/IFU?

Thanks for sharing your experience!

Regards