A Complete Guide to Medical Device Classes
As you read through this guide to medical device classes, you'll answer the question 'what are medical devices' as you develop an understanding of the differences between each medical device class with examples for each.
For this guide, we'll focus on the U.S. market. However, it's important to note that the market for medical devices is global. So now, let's start with the basics, what are medical devices?
In the U.S., a medical device is considered any instrument, apparatus, implement, machine, appliance, implant, or other equivalent invention created for use independently or in combination with something else for a medical purpose.
A medical device within the U.S. falls under three classifications:
- Class I – minimal potential harm to patients
- Class II – moderate potential harm to patients
- Class III – severe potential risk of illness or injury to patients, often considered for life support
As the class increases, so does the risk to the individual, and so does the required testing to ensure that the medical device is as safe and effective as possible.
Additionally, as the class and risk increase, so should the benefit to the individual.
Medical Device History and Present-Day Practice
By modern standards, the discovery of the medical device goes back as far as 7000 BC in Balochistan, modern-day Pakistan.
Neolithic dentists used bowstrings and drills tipped with flint during this time, making them the earliest known medical devices in human history. Furthermore, thanks to archeological efforts, we know that the use of medical devices was widespread during the era of ancient Rome, such as surgical instruments like bone levers and forceps.
Today, the largest market for medical devices is the U.S., with an estimated $159.80 billion of revenue generated in 2022 and an estimated increase of 6.78% annually from 2022-2027.
Medical Device Class I
In the U.S., the FDA (the U.S. Food and Drug Administration) defines a class I medical device as a device that presents minimal potential harm to the individual. They present minimal potential harm because they are simpler in design than class two or three medical devices.
Medical device Class I is the most common class for medical devices, with 47% of medical devices falling into this class. Furthermore, of that 47% of medical devices that fall into this class, 95% are exempt from regulations because of the low level of risk to the individual.
Examples of Class I Medical Devices
- Pregnancy Tests, Urine
- Manual Wheelchairs
- Manuel Stethoscopes
Next, we'll delve into medical device class two. But, first, let's briefly review the significant differences between a Class I medical device and a Class II medical device.
When it comes to the major differences between a class one medical device and a class two medical device, the most significant differences come down to the potential risk to the user and the complexity of the device.
The more complex the device, the greater the risk the user can experience. A class two medical device will also encounter stricter regulations and increased testing because of the greater risk before achieving FDA approval.
Medical Device Class II
In the U.S., the FDA defines a Class II medical device as a device that presents moderate potential harm to the individual. Class II are the second most common class for medical devices, with 43% falling into this class.
In addition, some medical devices, such as contact lenses, can fall into Class II or Class III. This potential increase in the class is because the potential risk to the individual can increase depending on its usage or composition.
Examples of Class II Medical Devices
Pregnancy Tests, Blood
Unlike urine based tests, these types of pregnancy tests fall into Class II because they present a greater potential risk to the user when drawing blood.
Soft Contact Lenses
Soft contact lenses fall into medical device Class II because they're usually made of silicone hydrogel.
Some types of software used to diagnose patients fall into Class II of medical devices because of the potential risk for cybersecurity threats. Patient privacy is regulated in the U.S. and laws protecting it are strictly enforced.
Lastly, we'll delve into medical device Class III. As with Class I and Class II medical devices, the significant differences come down to the device's complexity which increases its risk to the user and thus increases the required testing before it can achieve FDA approval.
Medical Device Class III
In the U.S., the FDA defines a Class III medical device as a device that presents severe potential harm to the individual. Class III are the least common class for medical devices, with only about 10% of medical devices falling into this class.
These devices are typically created and used to support life. When a medical device is implanted into the body, it exponentially increases the risk of a bad outcome.
Examples of Class III Medical Devices
Pacemakers fall into medical device Class III. While potentially life saving, pacemakers may cause damage to blood vessels and nerves or a collapse lung.
Breast implants fall into Class III because they're implanted into the patient and present unreasonable risk.
These implants fall into Class III because they are surgically implanted near the brain.
We've covered the basics of medical device classification, from breaking down the different class levels to reviewing a list of examples of medical devices for each class. Marketing and promoting each comes with its own challenges and regulations to adhere to. As a proven medical device marketing agency, ParkerWhite understands the challenges any class of medical device will face and how to overcome the barriers to successfully market and grow these products.