Regulatory Open Forum

Greetings,

According to GSPR 23.2(m), information on the label shall include 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. The info may be kept to a minimum in which case more detailed information shall appear in the IFU.

Currently, a draft packaging label has the warnings/precautions in English, French, and German. Space on the packaging label is limited and in the instance we enter additional markets in which we would need to translate, there may not be enough space on the label depending on the number of languages we would require. My manager has asked if the warnings/precautions can be included on the eIFU leaflet we place inside the product's packaging - which fulfills the requirement to provide it immediately to the user. The potential problem I foresee is that the leaflet would be considered information provided to the user according to GSPR 23.4(g). Note, we would have this information included in the IFU available electronically. 

My question is - would this alternative be acceptable? The leaflet is part of labeling and is imparting the necessary information immediately; it just wouldn't be on the packaging label.

Thoughts?

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Tonia Bryant
Director, Quality & Regulatory Affairs
Lucerno Dynamics, LLC
Cary NC
United States
------------------------------

Good Day Tonia,

We were advised by our engineering and scientific consultant firm to put the most important warning on the label and place the rest in the IFU using the IFU symbol on the label as we also have very limited landscape on our label.

with our website address under it.

I will quantify this by saying that we manufacture a Class I, non-sterile/non-measuring device.

Best regards,

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D Michelle Williams
VP - Operations
United States
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Original Message:
Sent: 02-Jun-2021 15:23
From: Tonia Bryant
Subject: Warnings/Precautions on Label (GSPR 23.2(m))

Greetings,

According to GSPR 23.2(m), information on the label shall include 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. The info may be kept to a minimum in which case more detailed information shall appear in the IFU.

Currently, a draft packaging label has the warnings/precautions in English, French, and German. Space on the packaging label is limited and in the instance we enter additional markets in which we would need to translate, there may not be enough space on the label depending on the number of languages we would require. My manager has asked if the warnings/precautions can be included on the eIFU leaflet we place inside the product's packaging - which fulfills the requirement to provide it immediately to the user. The potential problem I foresee is that the leaflet would be considered information provided to the user according to GSPR 23.4(g). Note, we would have this information included in the IFU available electronically.

My question is - would this alternative be acceptable? The leaflet is part of labeling and is imparting the necessary information immediately; it just wouldn't be on the packaging label.

Thoughts?

------------------------------
Tonia Bryant
Director, Quality & Regulatory Affairs
Lucerno Dynamics, LLC
Cary NC
United States
------------------------------

Our package labels are too small for anything beyond symbols indicating warnings. We also use both the symbol for consulting IFU and caution symbol when needed to consult the IFU for warnings and precautions. If you're including appropriate symbols on the package label to direct the user to information, that should be sufficient. Keep the text focused on the really critical information that you want the user to see before they even open the package.
Jackie

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Jackie Jaskula
Regulatory Affairs Manager
OrthoPediatrics
South Bend, IN
USA
------------------------------

Original Message:
Sent: 02-Jun-2021 15:23
From: Tonia Bryant
Subject: Warnings/Precautions on Label (GSPR 23.2(m))

Greetings,

According to GSPR 23.2(m), information on the label shall include 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. The info may be kept to a minimum in which case more detailed information shall appear in the IFU.

Currently, a draft packaging label has the warnings/precautions in English, French, and German. Space on the packaging label is limited and in the instance we enter additional markets in which we would need to translate, there may not be enough space on the label depending on the number of languages we would require. My manager has asked if the warnings/precautions can be included on the eIFU leaflet we place inside the product's packaging - which fulfills the requirement to provide it immediately to the user. The potential problem I foresee is that the leaflet would be considered information provided to the user according to GSPR 23.4(g). Note, we would have this information included in the IFU available electronically.

My question is - would this alternative be acceptable? The leaflet is part of labeling and is imparting the necessary information immediately; it just wouldn't be on the packaging label.

Thoughts?

------------------------------
Tonia Bryant
Director, Quality & Regulatory Affairs
Lucerno Dynamics, LLC
Cary NC
United States
------------------------------

Hello Tonia,

Jackie and Michelle have provided the most common approach when identifying warnings or cautions associated with a device - using the "i" in a book and the "!" in a triangle.  If I could make a couple comments in regard to your question about GSPR 23.2(m).  The first is remember "labels" can be broadly interpreted as not just the label on the device package.  As an example for this GSPR requirement, if you have a device with a heating aspect or a laser, you would want a label warning of heat or laser on the device itself in order of 'need to be brought to the immediate attention of the user'.  (There are symbols from safety standards for those also.)  The second comment is the symbols previously stated above are good, but consider any warning or caution as the user is opening/installing the device.  Luckily there are already symbols for some of these aspects like sterile, temperature, exposure, etc.  In application, most all warnings and cautions are stated in the instructions for use, package insert, quick guide, or whatever is used, but use the risk management process to clearly describe those warnings and cautions and include information how users need to be "informed" of the information, such as having statements in the IFU or if there is a need on the direct device label.​

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Richard Vincins RAC
Vice President Global Regulatory Affairs
Oriel STAT A MATRIX - ENTERPRISE
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Original Message:
Sent: 03-Jun-2021 08:13
From: Jackie Jaskula
Subject: Warnings/Precautions on Label (GSPR 23.2(m))

Our package labels are too small for anything beyond symbols indicating warnings. We also use both the symbol for consulting IFU and caution symbol when needed to consult the IFU for warnings and precautions. If you're including appropriate symbols on the package label to direct the user to information, that should be sufficient. Keep the text focused on the really critical information that you want the user to see before they even open the package.
Jackie

------------------------------
Jackie Jaskula
Regulatory Affairs Manager
OrthoPediatrics
South Bend, IN
USA

Original Message:
Sent: 02-Jun-2021 15:23
From: Tonia Bryant
Subject: Warnings/Precautions on Label (GSPR 23.2(m))

Greetings,

According to GSPR 23.2(m), information on the label shall include 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. The info may be kept to a minimum in which case more detailed information shall appear in the IFU.

Currently, a draft packaging label has the warnings/precautions in English, French, and German. Space on the packaging label is limited and in the instance we enter additional markets in which we would need to translate, there may not be enough space on the label depending on the number of languages we would require. My manager has asked if the warnings/precautions can be included on the eIFU leaflet we place inside the product's packaging - which fulfills the requirement to provide it immediately to the user. The potential problem I foresee is that the leaflet would be considered information provided to the user according to GSPR 23.4(g). Note, we would have this information included in the IFU available electronically.

My question is - would this alternative be acceptable? The leaflet is part of labeling and is imparting the necessary information immediately; it just wouldn't be on the packaging label.

Thoughts?

------------------------------
Tonia Bryant
Director, Quality & Regulatory Affairs
Lucerno Dynamics, LLC
Cary NC
United States
------------------------------

Hi Tonia! 

You have gotten some great feedback on your question, and all of the answers are spot on.  The biggest challenge to me is the question of " ... would this alternative be acceptable?"  The variables are so numerous, and the knowns are so few.  It is just hard to predict what will be acceptable. I would think that the classification of your device (I peeked at your company's webpage and am assuming med device) and the nature/potential harms associated with the device would feed into any risk-based decision on labeling content. 

I'm also curious as to how common it is in the industry to include an insert when going the eIFU route.  In my experience, labeling becomes symbol heavy out of necessity, including the "Consult IFU" symbol with website information.  The IFU made available electronically includes the required translations for affected regions/countries.  I would expect to eliminate an insert unless it has relevant information not included in the IFU itself.  I have seen cases where translations of the device name were added to each level of packaging as a separate label due to lack of space.  Of course, if your device is sterile, that additional label has to be taken into consideration for sterilization. Plus, the pending revision to ISO 15223-1 (as proposed) eliminates the definition of labeling in favor of "information supplied by the manufacturer", and it proposes changes in how/where the Caution (!) symbol is defined/used.  I see compliance with the labeling GSPRs changing yet again once that revision has been released and harmonized.

Thank you for posting the question as I think everyone looking at the EU market requirements could provide ideas on how to meet the acceptance criteria.  It is very helpful to read the responses!

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Robin Haden RAC
Sr. Regulatory Affairs Specialist
CryoLife Inc.
New Hill NC
United States
------------------------------

Original Message:
Sent: 02-Jun-2021 15:23
From: Tonia Bryant
Subject: Warnings/Precautions on Label (GSPR 23.2(m))

Greetings,

According to GSPR 23.2(m), information on the label shall include 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. The info may be kept to a minimum in which case more detailed information shall appear in the IFU.

Currently, a draft packaging label has the warnings/precautions in English, French, and German. Space on the packaging label is limited and in the instance we enter additional markets in which we would need to translate, there may not be enough space on the label depending on the number of languages we would require. My manager has asked if the warnings/precautions can be included on the eIFU leaflet we place inside the product's packaging - which fulfills the requirement to provide it immediately to the user. The potential problem I foresee is that the leaflet would be considered information provided to the user according to GSPR 23.4(g). Note, we would have this information included in the IFU available electronically.

My question is - would this alternative be acceptable? The leaflet is part of labeling and is imparting the necessary information immediately; it just wouldn't be on the packaging label.

Thoughts?

------------------------------
Tonia Bryant
Director, Quality & Regulatory Affairs
Lucerno Dynamics, LLC
Cary NC
United States
------------------------------