Most products that are intended to be used for medical purposes are classified as medical devices. Before a medical device is placed on the market and becomes available for purchase, it has gone through strict checks and design controls to ensure that it is safe to use and does what it is supposed to do.
Class, I medical devices is the least harmful type. In this category of medical devices, you will find for example foot arch supports and Band-aids but also many other products you may not be aware of are medical devices.
We’ll look at a few common items and products you’ve likely used many times in your life but may not have known are medical devices.
1. Condoms and pregnancy tests
Condoms, and on the opposite side of the spectrum – pregnancy tests, are regarded as class IIa medical devices by the EU Medical Device Regulation (MDR). You might have heard that there is no such thing as 100% effective birth control, other than abstinence, and that’s true.
However, to meet applicable standards, all condoms sold on the EU market must have a 99.6% test score. This means that 996 out of every 1,000 condoms must pass this test to be sold, which means that they’re 98% effective.
2. Hearing aid devices
While you might not have thought about it, it might not be surprising to find out that hearing aids are also a type of medical device. There are several types of hearing aids, such as behind-the-ear and in-ear hearing aids.
Whichever type of hearing aid you’re familiar with, if it helps to amplify sound, it is used for a medical purpose and is classified as a medical device.
3. Foot arch support and orthopedic shoe insoles
If you are suffering from pain in your feet, a foot arch support or shoe insole could help, especially if you walk a lot daily or live a very active life.
Pain can be reduced or even eliminated by supporting the arch of your foot with arch support inserts placed in your shoes, so not surprisingly, many arch supports and orthopedic insoles are actually medical devices.
4. Glasses and contact lenses
Glasses are not only one of the oldest medical devices, but they were also voted one of the most popular medical devices of all time by Qmed readers. According to the Vision Council of America, a whopping 75% of adults in the US use some kind of vision correction, such as glasses on a regular basis.
If you prefer contact lenses rather than glasses, well then it might be good to know that vision-correcting contact lenses are also medical devices. Contact lenses with aesthetic purposes, such as changing your eye color are however not medical devices. But under the new medical device regulation, they still need to meet the same requirements as regular contact lenses.
5. Sports tape and kinesiology tape
If you’re active and into sports, you have probably encountered one or two injuries throughout the years. You may have used sports tape, also known as athletic tape, which is a thick white fabric tape, to support a sprained ankle or write.
Well, this is a medical device too, and so is kinesiology tape, which is a stretchy fabric tape that is typically used to support muscular or tendon injuries.
6. Digital thermometers
A digital thermometer or a medical thermometer is a medical device used to measure body temperature and check if a person has a fever. This medical device is found in most homes, especially if you have children.
There are several types of thermometers, such as infrared thermometers and digital thermometers. Whether it is used in your ear, under your tongue, or rectally, it is a medical device.
7. Band-aids or plasters
Band-aids or plasters hardly need an explanation of what they do – they cover up small cuts or blisters on your skin. This is a standard part of all med kits at home when you’re traveling or camping, and most households have them at home in varying sizes and models.
Despite Band-aids being used for very small injuries, such as scrapes and small cuts, they are actually medical devices.
As you can see, medical devices come in all shapes and forms, and you probably have more of them at home than you realize. Think about which medical devices you use most frequently in your daily life. The answer might surprise you!