Examples of Medical Device Classification Rules

The term medical device covers a wide range of devices. Adhesive bandages, surgical masks, and tongue depressors are all medical devices, as are room-sized magnetic resonance imaging (MRI) machines. Even certain computer software programs are considered medical devices.

Any medical device poses some risk both during normal use and in cases of failure, but the harms associated with those risks vary widely. If a mallet for testing reflexes falls apart in use, the risk to the patient is much lower than if a pacemaker falls apart in the patient’s chest.

Because of this wide spectrum of risk, the U.S. Food and Drug Administration (FDA), as well as similar agencies in other countries, has a device classification system to categorize medical devices.

Each device is classified according to the intended use and the risk to the patient in normal use and in case of failure. The rigors and standards of testing for a device to be granted marketing approval depend on the classification of the medical device.

In this article we discuss the various medical device classification rules and how they are applied by regulators.

The FDA is tasked with the enforcement of regulatory controls that ensure the safety and effectiveness of medical devices. The U.S. FDA medical device classification database defines three classes of medical devices, called Class I, Class II, and Class III.

The European Medical Device Directive classification system is somewhat more complex, with subclasses of Class I and Class II, but is substantially similar to the medical device classification of the FDA. The following are the U.S. medical device classification definitions.

Class I Devices

Class I medical devices are simple devices that pose little or no risk to the patient or user. New Class I devices are subject to the FDA’s baseline “general” regulatory controls.

Medical device manufacturers apply for approval for a new Class I device by submitting a “510(k)” application, which for Class I devices involves minimal clinical trials. However, this is more of the exception than the rule.

Some Class I devices do not require a formal submission to the FDA. They require regulatory controls in design and manufacturing, but that requirement only goes as far as the manufacturer filing a notice of listing or intent of sale. This usually depends on the classification of the device.

Class II Devices

Devices with a medium level of risk fall into Class II. Class II medical devices require a higher level of scrutiny: the general controls, plus special controls related to the types of devices.

Like Class I devices, approval for Class II devices goes through the 510(k) “premarket notification” process. However, certain Class II devices that are not substantially similar to an existing device on the market must go through a full “premarket approval” process, which may involve full clinical trials.

Class III Devices

Class III devices involve the highest level of risk. Like Class II devices, their failure may cause harm or death to the patient.

The main difference between the two is that Class II devices have predicates that exist on the market, so the burden of proof of clinical effectiveness is lower than that of a Class III device. A Class III device generally has no predicate on the market.

The FDA (or one of its European equivalents, called a “notified body”) requires more extensive (and expensive) clinical trials to assure the safety and effectiveness of the device.

Depending on the device, the approval process can take several years and cost millions of dollars. It’s a high price to pay, but it’s small compared to the fines and lawsuit settlements that come from marketing an unsafe device.

Classifying Your Device

Classification of a medical device can be tricky sometimes. To help manufacturers classify their devices, the FDA medical device classification database is available, containing thousands of medical device classification examples.

According to the descriptions of medical devices, the product code, technical documentation, and other descriptors, the database indicates the classes of devices as well as the specific section of the U.S. Code of Federal Regulations that applies to each device.

This tool helps manufacturers determine the classification of their proposed devices and what specific requirements each one must meet for approval. This, in turn, helps them plan their investment in the approval process.

Get Classification of Medical Device Support From Experts

RBC Medical Innovations has long experience navigating the medical device regulatory waters. Whether you are seeking approval in the U.S. or aiming for the CE marking to sell your device in Europe, we can help determine the proper medical device classification for your proposed device and guide it through the approval process.

Get expert support throughout the entire design, development, and market deployment process, ensuring your medical device reaches the market fast and error-free. Contact us today to learn more.

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