Anon,
If there is limited space on the device itself (assuming it is reusable) there are indeed creative ways which may need to be done. Whatever ways the device is properly identified, ensure the technical information around the device and decisions on labelling are clearly documented. As an example, if the device label can only have the part number and serial number, then the rest of the information may/can be placed on the packaging label. Describe this in the technical information so it is understood there is still traceability on the device itself, e.g. part number and serial number, with all of the other information kept on the packaging. In fact, you can include "stickers" in the packaging or place to enter on the Manual or Instructions For Use (IFU) the pertinent information about the device also.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
Oriel STAT A MATRIX - ENTERPRISE
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Original Message:
Sent: 20-Nov-2023 11:21
From: Anne LeBlanc
Subject: Information on Device Label
Hello Anon
Is this thing single-use or reusable? Who will use it? When they find one somewhere, what will they want to know about it? Can you silkscreen, or emboss, or etch, or dangle a tag, or add information in any way other than an adhesive label?
The applicable regulations and standards allow for a little bit of flexibility and creativity.
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Anne LeBlanc
United States
Original Message:
Sent: 17-Nov-2023 16:58
From: Anonymous Member
Subject: Information on Device Label
This message was posted by a user wishing to remain anonymous
My company is developing a class I device that will be made available in the U.S., Canada, and the EU. It will be GMP exempt in the U.S. The shape/form of the device will only allow for a label about that is about 1" by .5" to be placed directly on the device and even this might require some creativity and/or new production equipment. All other surface areas are curved or shaped in a way that would not allow for a sticker or other type of label to be applied.
Does anyone think it is justifiable to only have a label on the immediate packaging in this case? Or should we place the most important information on a 1" by .5" label while also having a label will all required information on the immediate packaging? What would you consider to be the most important information to include on this label? CE mark? UDI? Something else?
Thanks in advance!