You would be surprised at how many products and items you use in your everyday life that are actually medical devices. Band-Aids, fever thermometers, condoms and contact lenses are all different medical devices.
Considering how many other medical devices you have in your home, or use regularly, it can be useful to understand some of the most common symbols you will find on these products and their packaging.
Why do you need to know what the symbols on medical devices mean?
In the EU, medical devices are regulated by the Medical Device Regulation and standards and rules apply to which information should be found on a medical device, its packaging, labelling and the instructions for use.
It’s also the most accessible information you can get hold of to understand how to safely use a medical device. This is a layperson’s guide to understanding some of the most common symbols you will find on medical devices.
The CE mark ensures compliance with EU norms
A CE mark is required by the Medical Device Regulation in the EU. This CE mark certifies that medical devices traded within the European Economic Area (EEA) comply with EU health, safety, and environmental norms.
The letters ’CE’ must be presented in the standard, recognisable form, and follow the sizes and styles defined in the medical device regulation Annex V.
The Unique Device Identifier (UDI) identifies devices
A UDI is assigned to each medical device as a unique numeric or alphanumeric code. It allows for the identification of devices the tracking of them. A device identifier (UDI-DI) and a production identifier (UDI-PI) are included in the UDI.
The UDI offers access to device information because of its specificity. The UDI also improves patient safety and combats counterfeiting by making device tracking more efficient.
The EC-REP symbol signifies the authorized representative
For medical devices where the manufacturer is outside the EU, you can find the EC-REP symbol. It signifies the name of the European authorised representative that represents the medical device manufacturer outside of Europe in relation to European requirements.
The factory symbol provides information about the manufacturer
There are several factory symbols, the most common are a white factory and a black factory. The white factory symbol provides information about the product manufacturer while the white symbol specifies the manufacture date.
Please note, that manufacturer in a medical device context, does not necessarily mean the company that is producing the medical device, but rather the company that is responsible for the product. The actual production may very well be outsourced.
The hourglass indicates the product expiry date
You may have seen a symbol of an hourglass on medical devices and products before. This symbol will be found next to a date, which indicates that this is the expiry date. The product should be used prior to this date.
A circle with a crossed-out number 2 indicates single use
Another useful symbol is a circle with a number 2 and a line crossing it. This symbol means that the medical device is only intended to be used once. It is a single use product and should be disposed of after use.
There are certainly many other symbols on medical devices and medical device packaging, such as the distributor, the importer, the LOT number, and the reference number of the device. But these are the six perhaps most common symbols you will find on medical devices in your everyday life.