What's the difference between a Class I and Class II medical device? (2024)

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.

Download medical device classification PDF guide

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.

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.

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.

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

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:

Determine if your medical device is non-invasive, invasive, active, or special.
Find out what your class is. (Guidance on the Risk-based Classification System for Non-Invitro Diagnostic Devices)
Class II or higher medical devices have to become part of the MDSAP (Medical Device Single Audit Programme)
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 when it's time to tackle your 510(k) or PMA submissions.

"I've worked in companies using paper before.
It's possible to comply - but it's a lot of work and there aren't enough hours in the day.
Qualio's made my life 100% better!"
— Angela Pinkston, Quality Assurance Manager, Akadeum Life Sciences

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. If you have more questions if your medical device fall under the Class I or Class II category contact us today.

FAQs

What's the difference between a Class I and Class II medical device? ›

FDA Medical Device Classifications

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What is the difference between Class 1 and Class 2 medical equipment? ›

Class I devices are low-risk devices. Examples include bandages, handheld surgical instruments, and nonelectric wheelchairs. Class II devices are intermediate-risk devices. Examples include computed tomography (CT) scanners or infusion pumps for intravenous medications.

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What is considered a Class II medical device? ›

Class II medical devices, which pose a medium to high risk to patients and users, account for 43 percent of all medical devices in the United States. Some common examples of Class II devices are syringes, pregnancy test kits, electric wheelchairs, and catheters.

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What does Class I medical device mean? ›

Medical device licence

This approach means that all medical devices are grouped into 1 of 4 classes. Class I devices (such as a wheelchair) present the lowest potential risk. Class IV devices (such as a pacemaker) present the greatest potential risk.

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What is medical device risk class I? ›

These risk classes range from Class I (low risk) and IIa and IIb to Class III (high risk). Class I products are additionally subdivided according to whether they require sterilisation (Is) or include a measuring function (Im) which is relevant for the further conformity assessment procedure.

Do Class 1 medical devices need a 510 K? ›

Most Class I and Class II devices are exempt from premarket notification [510(k)] requirements. They may also be exempt from the current Device Good Manufacturing Practices (GMP), requirements under the Quality System (QS) Regulation.

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What are Class II equipment? ›

In Class 2 appliances, the user is protected by at least two layers of insulation. For this reason, Class 2 appliances are also known as Double Insulated. They do not require an earth connection.

Can you sell a Class 2 medical device? ›

If your device is classified as Class I or II, and if it is not exempt, a 510k will be required for marketing. All devices classified as exempt are subject to the limitations on exemptions. Limitations of device exemptions are covered under 21 CFR xxx. 9, where xxx refers to Parts 862-892.

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Are tampons a Class 2 medical device? ›

The U.S. Food and Drug Administration (FDA) classifies menstrual tampons as Class II (non-significant risk) medical devices and pads as Class I medical devices. This means manufacturers are required to submit to FDA a detailed risk assessment of the device components, the design, and test results.

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Do Class II devices need FDA approval? ›

The device classification regulation defines the regulatory requirements for a general device type. Most Class I devices are exempt from Premarket Notification 510(k); most Class II devices require Premarket Notification 510(k); and most Class III devices require Premarket Approval.

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How do you determine medical device classification? ›

The FDA categorizes medical devices as either Class I, Class II, or Class III. This three-tier classification is based on the product's intended use, indications for use, and the risk that it poses. Indications for use describe the disease or condition the medical device will diagnose, treat, prevent, or cure.

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What are Class 1 medical device standards? ›

The FDA defines Class I devices as: "not intended for use in supporting or sustaining life or of substantial importance in preventing impairment to human health, and they may not present a potential unreasonable risk of illness or injury."

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Are syringes Class 1 medical devices? ›

Class II medical devices require more FDA regulation to assure safety and effectiveness. X-ray systems, contact lenses, syringes, and blood transfusion kits all fall under this medical device classification.

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What are Class I II and III medical devices? ›

The regulatory controls for each device class include: Class I (low to moderate risk): general controls. Class II (moderate to high risk): general controls and Special Controls. Class III (high risk): general controls and Premarket Approval (PMA)

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What are high risk class medical devices? ›

Class I Medical Devices are low-risk devices. Class IIa Medical Devices are low to medium risk devices. Class IIb Medical Devices are medium to high-risk devices. Class III devices have the highest risk.

Are Class 3 medical devices high risk? ›

Class III medical devices are those devices that have a high risk to the patient and/or user. These devices usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury. They represent 10% of medical devices regulated by the FDA.

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What is the definition of class 1 2 3 medical devices? ›

Class I includes devices with the lowest risk and Class III includes those with the greatest risk. As indicated above all classes of devices as subject to General Controls. General Controls are the baseline requirements of the Food, Drug and Cosmetic (FD&C) Act that apply to all medical devices, Class I, II, and III.

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Do Class 2 medical devices require FDA approval? ›

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What is required for a Class 1 medical device? ›

Class 1 medical devices are devices with low or moderate risk to patient health and safety. 47% of approved medical devices are Class 1, and 95% of these devices are exempt from the PMA pathway to regulatory approval. Class 1 device manufacturers are required to register their device with the FDA, however.

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What is class of equipment class I? ›

Class I Equipment

In a Class I appliance, the body or casing, which is usually made of metal, is connected to earth via an earth wire and plug. This earth connection provides an alternate path for electric current to flow in case of a fault, such as a failure of basic insulation.

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