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4 Common Misconceptions About Medical Device Labeling
Medical device labelling requirements Manufacturers of electronic devices covered under a set standard shall give the following details on a label or tag permanently written on the product.
By: Medical Device Consulting Company
• Symbols, labels, instructions, warnings and control labels applied to the medical device by coding colour, moulding, machining or printing.
• The information is shown on the medical device User Interface
• Documents were given with the device like installation instructions, user manuals, as well as maintenance instructions
• Details printed on the device packaging
Medical Device Labeling has 4 common misconceptions as follows:
1. MEDICAL DEVICE LABELING IS JUST THE LABEL ON THE DEVICE
Before going further, it is very important to get on a big misconception cleared up. Most of the people think that medical device labelling is just the label on the device. When we mention about the label(s) it means we are talking about the device labels that are on the box or pouch. they do not consider IFU ( information for use).As per FDA labelling…
"All "label, instructions for use, and any other information that is related to identification, technical description, intended purpose and proper use of the medical device, but excluding shipping documents".
Well, the medical device labelling is extremely important, it not that something to be done at the end of the project. So, you can do it in between as it's not the matter of duplicating hat the other has done.
General details about labelling
The specifications for what should not or should be included in labelling is governed by FDR 21 code 801 You know that the labelling of the medical device comes attached along with the device or inside the device.
Medical device labelling (https://www.operonstrategist.com/
• Canada: Canadian Medical Device Regulations clause 21
• EU: Medical Device Directive Annex 1, clause 13
• USA: FDA CFR 21 Part 801
According to statistics that in spite of showing 5% of the world population. Us produces more waste than any other country worldwide. That waste sometimes even extends into medical practices as well as the devices used to improve the health of our patients. Not every device or product labelled "Single-use:
Whom there are items in medical practice that are made to use only once, there is really a huge benefit to reprocessing certain medical devices labelled as use once devices.