The definition of a medical device is a simple textbook answer. For the sake of clarity, the exact meaning has been shaped over the years based on what a device does or is intended to do. Here, we are going to discuss the technical definition and what that means for the laymen.
Defining a Medical Device
According to ce-marking.com, a medical device, or MD, is defined as “any instrument, apparatus, appliance, material, software, or other article, whether used alone on in combination, including the software necessary for the proper application, intended by the manufacturer” to be used for patients for the function of a specific list of criteria:
- Diagnosis, prevention, monitoring, or treatment of disease
- Diagnosis, prevention, monitoring, or treatment of an injury or handicap
- Investigation, replacement, or modification of the anatomy, or of a physiological process
- Control of conception
This description also excludes devices that function by pharmacological, immunological, or metabolic means. Further complicating the matter, many devices could be considered medical devices purely depending on their intended purpose for use. This includes many toiletry and cosmetic products. This possible list of medical devices refers to items such as:
- Toothbrushes, dental sticks, dental floss, dental chewing gums
- Baby diapers, tampons, mattress protectors
- Instrument for tattooing
The Class System
To try and simplify all of this, the medical devices industry has agreed to specify other criteria and classifications that can further explain what a medical device is. Once something is certified as a medical device, it is further defined by separate classes. According to the Federal Drug Administration, or FDA, “Devices are classified into one of three regulatory classes: Class I, Class II, or Class III.”
These classes also include some subclasses, such as Class Is, Class Im, Class IIa, and IIb. There are a series of factors that could alter the classification of a medical device. It is usually the intended purpose of the device, assigned by the manufacturer, that determines the class of the medical device. The factors that could alter a device’s class include:
- The amount of time the device is intended to be used continuously
- Whether the device is surgically invasive
- Whether or not the device is active or implantable
- Whether the device holds a substance that is ancillary to the primary use of the said device
Why is a Class System Needed?
Healthcare and medical devices are held to a higher standard than other regular devices. This is because of their uses in the care of human beings. The companies that invent these devices and the official organizations that regulate them have to take their definitions very seriously. This is also how the medical device market is regulated. The FDA medical device classification database has to be able to break down and explain what every device is and what it does. This also helps to avoid patent conflict and later disputes about the intended use of a device.
According to ce-marking.com, it would be impossible to try and test all new medical devices to the most “rigorous conformity assessment procedures available.” This is why the class system was created. To speed up and simplify the process for medical device companies as much as possible, they chose not to judge these devices on just their technical features.
Doing so would be too complicated because many devices have more than one use or could have a different use in the future. Instead, they chose to classify a device “based on potential hazards related to the use and possible failure of devices taking account of technology used and of health policy considerations,” meaning just judging a device by how it affects the human body.
For a complete breakdown of how medical devices are separated into their classes, visit ce-marking.com.