Regulatory Open Forum

Hello all. I have been asked by marketing whether it is acceptable to include picture-only instructions on the immediate packaging of a Class II/IIa medical device, to be sold in US, EU, and CAN. It would be accompanied by an IFU with full instructions translated into all pertinent languages. They are acknowledging that many doctors will not consult the full IFU with every use of the device, and that to have a quick reference of the 5-step process would be beneficial. They would happily include the brief English text with each picture, but in Europe this would have to be translated into many other languages, hence their questions about leaving the text out entirely. 

I know that internationally recognized symbols are fine, but pictures are an entirely different concept. The pictures are very simple and we think they are self-explanatory, but I I suspect that this is simply not an option.

Any feedback would be appreciated.

Best,

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Lillian Erickson
RA Manager
Salt Lake City UT
United States
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If this pictorial representation is like a "quick guide" that is accompanied by full text of instructions for use, I would not see why that would not be accepted.  There are benefits to having a quick guide, especially to identify key steps/tasks or more importantly identification of warnings/cautions.  When I get something new especially something that I have used many times before, I hardly ever read the instructions.  I only refer back to them when I get stuck.  Though I usually always glance through the quick guide.  As long as the full instructions for use translated in appropriate local language this would I think actually help in risk reduction because if you already know the physicians do not read the instructions for use regularly, then a quick guide can convey important information.

My recommendation is that if this approach is taken, make sure you read through MDD ER 1 - 6 and 13 and MDR GSPR 1 - 9 and 23 to make sure all information being conveyed is acceptable (risk related).  Then directly link this to your risk management process on how information supplied to the user is addressed by this pictorial representation and a full instructions for use.  It also might be highly recommended to conduct a Usability study with this pictorial guide compared to instructions for use compared to physician knowledge to support that the pictorial guide does not introduce any new risks or hazards, in fact maybe even reducing some risks or hazards.

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Richard Vincins RAC
Vice President Regulatory Affairs
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Original Message:
Sent: 26-Jun-2018 10:13
From: Lillian Erickson
Subject: PictorialoOnly Instructions for Medical Device

Hello all. I have been asked by marketing whether it is acceptable to include picture-only instructions on the immediate packaging of a Class II/IIa medical device, to be sold in US, EU, and CAN. It would be accompanied by an IFU with full instructions translated into all pertinent languages. They are acknowledging that many doctors will not consult the full IFU with every use of the device, and that to have a quick reference of the 5-step process would be beneficial. They would happily include the brief English text with each picture, but in Europe this would have to be translated into many other languages, hence their questions about leaving the text out entirely.

I know that internationally recognized symbols are fine, but pictures are an entirely different concept. The pictures are very simple and we think they are self-explanatory, but I I suspect that this is simply not an option.

Any feedback would be appreciated.

Best,

------------------------------
Lillian Erickson
RA Manager
Salt Lake City UT
United States
------------------------------

Original Message------

Hello all. I have been asked by marketing whether it is acceptable to include picture-only instructions on the immediate packaging of a Class II/IIa medical device, to be sold in US, EU, and CAN. It would be accompanied by an IFU with full instructions translated into all pertinent languages. They are acknowledging that many doctors will not consult the full IFU with every use of the device, and that to have a quick reference of the 5-step process would be beneficial. They would happily include the brief English text with each picture, but in Europe this would have to be translated into many other languages, hence their questions about leaving the text out entirely. 

I know that internationally recognized symbols are fine, but pictures are an entirely different concept. The pictures are very simple and we think they are self-explanatory, but I I suspect that this is simply not an option.

Any feedback would be appreciated.

Best,

------------------------------
Lillian Erickson
RA Manager
Salt Lake City UT
United States
------------------------------

Thanks for the feedback!

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Lillian Erickson
QA/RA Director
Salt Lake City UT
United States
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Original Message:
Sent: 27-Jun-2018 07:17
From: James Bonds
Subject: PictorialoOnly Instructions for Medical Device

Hi Lillian,

My firm manufactures a device which includes only pictures as the IFU.  It seems similar to yours, in that a full IFU with translation is included with the first use of the device, but since the product we manufacture is a single use disposable, the full IFU is not provided with the "refill" devices.  We have not had any issues with regulatory bodies once this is explained to them.

Regards,

James

Original Message------

Hello all. I have been asked by marketing whether it is acceptable to include picture-only instructions on the immediate packaging of a Class II/IIa medical device, to be sold in US, EU, and CAN. It would be accompanied by an IFU with full instructions translated into all pertinent languages. They are acknowledging that many doctors will not consult the full IFU with every use of the device, and that to have a quick reference of the 5-step process would be beneficial. They would happily include the brief English text with each picture, but in Europe this would have to be translated into many other languages, hence their questions about leaving the text out entirely.

I know that internationally recognized symbols are fine, but pictures are an entirely different concept. The pictures are very simple and we think they are self-explanatory, but I I suspect that this is simply not an option.

Any feedback would be appreciated.

Best,

------------------------------
Lillian Erickson
RA Manager
Salt Lake City UT
United States
------------------------------