Understanding the Differences between Class I, II and III Medical Devices

Understanding the Differences between Class I, II and III Medical Devices

by Conelec Team

We manufacture a good amount of medical devices for clients but one thing that may not be clear prior, is the classifications of the devices. Depending on consumer risk and how complex the design is, FDA guidelines must be met. Let’s dive into what defines each Class.

Explaining Class I Medical Devices:
A Class I Medical device can be described as simple. That describes the design and the fact that it holds almost no potential risk. There are some general FDA policies it must follow, such as registering the device, branding with labeling, proper manufacturing (hello!) and the FDA has to alerted prior to marketing. A good example of a Class I device would be bandages or examination gloves.

Explaining Class II Medical Devices:
A Class II Medical device are much more complicated in design and of course, risk. A Class II must have special labeling, meet mandatory performance standards and post-market surveillance. In general, most medical devices will fall under the Class II categorization. Some examples would be powered wheelchairs and x-ray machines.

Explaining Class III Medical Devices:
A Class III Medical device are very complicated and intricate in design. This is where strict guidelines will come into play, mostly because these devices pose the greatest risk. Class III follows the same guidelines as I and II, but also has to have pre-market approval by the FDA, a scientific review before marketing. Class III devices at times will be relied on to sustain human lives, so malfunctions are not acceptable in a any manner. Some examples would be pacemakers, cerebral simulators and heart valves.

Now that we’ve discussed classifications, let’s talk about manufacturing. If you have a medical device you’re looking to produce, give us a call at: 386-873-3800 or email: info@conelec.net.


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