Classification of Medical Devices
17 May 2018
A medical device is designed to contribute on improving patient’s health through diagnosis, therapy or surgery which are monitored and under strict regulations by the Food and Drug Administration (FDA). The FDA has established the classification of medical devices for 1700 different generic types of devices within its industry. How are these types of devices classified, and which devices belongs to what class? The classification of medical devices is explained in this article.
The medical devices are classified into 16 medical specialities such as dental, cardiovascular, orthopedic, ear, nose, and throat devices. These devices can be assigned to one of the three medical device classes, based on the level of regulatory control to assure the effectiveness and safety of the device.The classification of each device depends on the indicated use of the medical devices and upon the amount of risk related to the device. The medical devices classification consists of: Class I, Class II, and Class III.
Based on the following factors the classification of medical devices has been made:
- The period of usage of the medical devices
- Whether the medical devices are surgically invasive
- Whether the medical devices contains medical substances
- Whether the medical devices are active or surgically implantable
Class I – General Controls
The classification of medical devices starts with Class I, which stands for “General Controls”, 47% of the medical devices belongs to this category. The medical devices that are assigned to this class are quite simple in their design with low to no potential risk, and therefore these devices are required to comply with the lowest level of regulatory surveillance. Devices such as dental floss, bandages, enema kits, tongue depressors, and similar medical devices that are used in the medical, dental and surgical fields, belong to this class.
Class II – General and Special Controls
Another group in the classification of medical devices is Class II, which are subject to “General and Special Controls”. 43% of the medical devices belongs to this category. The medical devices within this class are simple as well, but more complicated in terms of design. These devices are considered to have a slight higher risk than devices in Class I, and therefore it is required to have a more strict regulatory surveillance in order to assure effectiveness and safety. The strict control can include required performance standards or labeling of the device. Examples of devices within this class are: pregnancy tests, infusion pumps, surgical needles, and wheelchairs.
Class III – General Controls and Premarket Approval
Class III is the third and last category that belongs to the classification of medical devices, which stands for “General Controls and Premarket Approval”. The medical devices within this class are more complex in design and are considered to have the greatest risk, which consist of 10% of all medical devices, and therefore these devices require strict guidelines. In order to assure effectiveness and safety of these devices, a more stringent regulatory surveillance is essential. Class III needs to meet the requirements of Class I and Class II, and on top of that these devices must also be pre-market approved by the FDA. Devices such as breast implants, heart valves, and implantable pacemakers are assigned to Class III.
The importance of the classification of medical devices
Nowadays the medical devices industry in Europe counts for one third of the global market with 22.000 companies within Europe. The Food and Drug Administration has established the classification of medical devices for 1.700 different generic types, classified into 16 medical specialities, and assigned to one of the three classes. To assure the effectiveness and safety of every medical device used and to prevent problems, the classification of medical devices is essential and should be followed strictly by everyone who uses medical devices.