Docfan Academy

A medical device is an instrument, machine, kit or material used on people to find, prevent, monitor or treat illness or injury. A medicine works mainly by a chemical effect inside the body. A device works mainly by physical means, or by testing a sample outside the body.

What counts as a device, and how risky is it?

• Simple: thermometer, bandage, examination gloves, syringe.
• Middle: blood pressure monitor, glucose meter, pulse oximeter, wheelchair.
• Complex: ECG machine, ultrasound, infusion pump, blood analyser, ventilator.

Laboratory test kits and reagents (in vitro diagnostics) belong to the device family too.

Regulators group devices into classes by risk, from low to high. A tongue depressor is low risk. A syringe or a blood pressure monitor sits in the middle. An implant or a ventilator is high risk. The higher the risk, the stricter the control, the more evidence the maker must show, and the more training the user needs. The exact class rules are set nationally, so follow the current EFDA directives.

Buy only from a registered, licensed supplier

A fake or badly made device can give wrong results or hurt someone. Before you buy, check that:

• the supplier holds a valid licence, and the product is registered as the current EFDA directives require;
• the label shows the manufacturer, the model, the lot or serial number and, for sterile items, an expiry date;
• warranty and service are offered, and you keep the invoice.

Read the instructions for use

The manufacturer writes the instructions for use (IFU). It tells you what the device is for, how to use, clean and store it, what to avoid and how long it lasts. Read the IFU before first use and show it to your colleagues.