Regulatory Open Forum

 View Only
  • 1.  Information on Device Label

    This message was posted by a user wishing to remain anonymous
    Posted 20-Nov-2023 09:06
    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!

  • 2.  RE: Information on Device Label

    Posted 20-Nov-2023 11:21

    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.

    Anne LeBlanc
    United States

  • 3.  RE: Information on Device Label

    Posted 21-Nov-2023 04:25


    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.

    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs

  • 4.  RE: Information on Device Label

    Posted 22-Nov-2023 10:01

    Without knowing what is the device type, I can give you few inputs. Provide product/production identifiers such as REF, Device name, CE mark, LOT and UDI directly on the device either with the label or laser marked, depending on the device. The rest of information can be supplemented with the label on the packaging. If you cannot provide all mentioned on the device, put it on the packaging but provide technical justification why it cannot fit.  

    Dusica Milenkovic
    NuVasive Netherlands B.V