medical devices mean

You would be surprised at how many products and items you use in your everyday life that are 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 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, which applies standards and rules regarding what information should be found on a medical device, its packaging, labeling, and instructions for use. 

It’s also the most accessible information on how to use a medical device safely. This is a layperson’s guide to understanding some of the most common symbols on medical devices.

The CE mark ensures compliance with EU norms.

The Medical Device Regulation in the EU requires a CE mark. This 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, recognizable 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 and tracking of devices. A device identifier (UDI-DI) and a production identifier (UDI-PI) are included in the UDI. 

Because of its specificity, The UDI offers access to device information. By making device tracking more efficient, it also improves patient safety and combats counterfeiting. 

The EC-REP symbol signifies the authorized representative

You can find the EC-REP symbol for medical devices manufactured outside the EU. It signifies the name of the European authorized representative representing the medical device manufacturer outside of Europe about European requirements. 

The factory symbol provides information about the manufacturer

There are several factory symbols; the most common are white and black factories. The white factory symbol includes 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 producing the medical device but rather the company responsible for the product. The actual production may very well be outsourced.

The hourglass indicates the product expiry date. 

You may have seen an hourglass symbol 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 before this date. 

A circle with a crossed-out number 2 indicates single-use

Another valuable symbol is a circle with the 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 their packaging, such as the distributor, the importer, the LOT number, and the device’s reference number. But these are the six perhaps most common symbols on medical devices in everyday life.