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. As an industry-leading eQMS provider, 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.

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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.

Related Reading: How Long Does the FDA Medical Device Approval Process Take?

How to Determine What Class Your Medical Device Is in the United States

The process for classifying your medical device is a little more complicated in the United States than it is in Europe or Canada.

These are the five steps that you’ll need to take to classify your device with the FDA:

  1. Define the intended use of your medical device.
  2. Define the indications for use for your medical device.
  3. Find the regulations and classifications for your medical device. (CFR Title 21: Food and Drugs-Parts 862-892)
  4. Find the product codes for your medical device. (FDA Product Classification Database)
  5. Determine your path to market.

Step one is where you define the intended use of your medical device. What does intended use mean?

Intended Use: the objective intent of the persons legally responsible for the labeling of drugs. The intent is determined by such persons’ expressions or may be shown by the circumstances surrounding the distribution of the article. [Source: FDA]

Indications for Use: the specific disease or condition that your medical device is used to treat, diagnose, mitigate, prevent, or cure. You’ll need to visit the links above and follow the instructions on those pages to complete steps 3 and 4.

After you’ve completed steps 1–4, you can then tackle step 5 and create your plan for bringing your medical device to market.

Related Reading: What Are the Differences in the FDA Medical Device Classes?

How to Determine What Class Your Medical Device Is in Europe

The European Union has a much simpler process than the FDA does, and it only includes three steps.

  1. Determine if your medical device is non-invasive, invasive, or active.
  2. Find out what regulations your medical device has to follow and what class it is. (Annex VIII)
  3. Determine your path to market.

In step one, you need to determine if your medical device is non-invasive, invasive, or active. Let’s define what each of these means, so you know which one your device is.

Non-Invasive: your device doesn’t penetrate the body through any surface or orifice.

Invasive: your device penetrates the body completely or partially through any surface or orifice.

Active: your device relies on a source of energy not generated by the human body to work.

Once you know which one of these your medical device falls under, you can visit the link in step 2 to find out what class your device is. The last step is where you put all the information together then come up with your plan for getting the device to market.

Related Reading: Does an FDA Class I Medical Device List Exist?

How to Determine What Class Your Medical Device Is in Canada

Canada Health has a similar process as the European Union. But they have an additional step to follow as well as another term you need to know.

The four steps of their process include:

  1. Determine if your medical device is non-invasive, invasive, active, or special.
  2. Find out what your class is. (Guidance on the Risk-based Classification System for Non-Invitro Diagnostic Devices)
  3. Class II or higher medical devices have to become part of the MDSAP (Medical Device Single Audit Programme)
  4. Determine your path to market.

You know what non-invasive, invasive, and active mean. But what about special?

Special: a special device is any device that is used for disinfecting or sterilizing blood, organs, or tissues for transfusions, as well as other medical devices—such as autoclaves or ultraviolet sterilizers.

Once you have defined what type your medical device is, visit the links and follow the directions included on those pages for steps 2 and 3.

Determining your path to market in step 4 is the same as it was for the EU and the FDA.

Related Reading: 9 Ways Canadian Medical Device Regulations Differ From the U.S.

Is an eQMS Right for Your Company?

To keep track of the product's lifecycle, every medical device manufacturer has to have quality management processes in place.

You need to track the lifecycle of your device not only for maintaining compliance but also for improving your overall product quality.

The better you track what steps and actions are taking place, the easier it will be to spot potential problems early enough to prevent them from impacting patients or healthcare providers.

Paper-based quality management systems (QMS) are a thing of the past. They may have worked well enough back in the day, but times and regulations keep evolving, so we don’t recommend you use this type of legacy approach for much longer.

If you find yourself in this situation, you’ll need to upgrade your system to an eQMS as soon as possible to prevent future problems down the road when it comes time to pass inspections and clinical trials.

“Coming from a manual, paper-based system, it’s amazing how it all just works. Qualio has forever changed how we manage quality.” — Tara Fitzpatrick, Quality Manager of Rowa Pharmaceuticals

Before you purchase an eQMS, you need to learn what questions you should ask to ensure you are buying a solution that does everything you need it to with an interface that’s easy to use.

To make your decision-making process easier, check out our free guide to learn the 12 questions you need to ask before purchasing an eQMS. New call-to-action

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Published by Robert Fenton May 5, 2020
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