Does your medical device fall under the Class I or Class II category? Depending on where you manufacture and sell your products, you'll need to classify each device for the U.S. FDA, European Commission, or Health Canada.
Unfortunately, determining which category your device falls under may leave you feeling a little confused and overwhelmed. We're here to explain the differences between a Class I and Class II medical device and how you can find the right category for your product.
What's the Difference Between a Class I and Class II Medical Device?
SIDE-BY-SIDE COMPARISON
To get a basic understanding of what classes each regulatory organization has and what they mean, let’s take a brief look at each of them.
FDA Medical Device Classifications
Class I: A medical device with low to moderate risk that requires general controls.
Class II: A medical device with a moderate to high risk that requires special controls.
Class III: A medical device with high risk that requires premarket approval.
European Union Medical Device Classifications
Class I: A medical device with low risk.
Class IIa: A medical device with low to medium risk.
Class IIb: A medical device with medium to high risk.
Class III: A medical device with the highest possible risk.
Canada Health Medical Device Classifications
Class I: A medical device with low risk.
Class II: A medical device with low to medium risk.
Class II: A medical device with medium to high risk.
Class IV: A medical device with the highest possible risk.
WHY REGULATORY CLASSIFICATION IS IMPORTANT
The higher the risk of serious injury or fatality, the higher the classification number will be. When you sell your medical device internationally, you’ll need to classify your device with multiple organizations.
In the United States, it’s the FDA (the Food and Drug Administration), in Europe, it’s the European Commission, and in Canada, it’s Health Canada.
Each of these regulatory organizations has different ways of classifying medical devices with different rules you have to follow, depending on what classification your device falls under.
Let’s dive into what it takes to classify your medical device with all three.