United States Food and Drug Administration (FDA) regulates all medical devices manufactured in the U.S. The FDA regulations, coupled with European Commission regulations, nearly cover all international distribution of medical devices. However, not all manufactured medical devices go through the same regulations. Depending on the possible risk factors, safety, and reliability of the devices, FDA and European Commission classify them into three different classes.
These three different classes undergo different regulations, and as a medical device manufacturer, it is essential to understand the classification before bringing a new product on the market. In this article, we will provide an overview of medical device classification and lay out a guideline to readily determine the class of your medical device and help you prepare accordingly.
Why Is Medical Device Classification Required?
As a medical device manufacturer, it is compulsory to follow the appropriate regulations before selling medical device products on the market. These rules of manufacturing and regulatory process producing medical devices are determined by the U.S FDA or the European Commission, and unless strictly maintained, the manufactured products have the possibility of not getting accepted for distribution internationally.
But why are such regulations required, and why do they vary for different device classes? As medical devices are directly linked to the patient’s health and welfare, it is the task of the U.S FDA CDRH and EC to ensure safety before the distribution of devices. Thus, by understanding these classes and pertinent regulations, you can:
- Determine the essential requirements and regulations to follow before starting the distribution on the market.
- Verify the risk associated with using newly manufactured medical devices.
- Identify the required time and cost to manufacture and distribute.
The reason for the three different medical device classes is mainly because of different devices having different risk factors. As an example, common first aid products like bandages and life-sustaining medical devices like Defibrillators, Dialysis equipment, etc., do not pose the same risk.
Therefore, all medical devices are grouped into three different classes so the regulation process related to the risks of the devices can be easily maintained by both the manufacturers and customers. Depending on the classes, the manufactured medical device may have different exemptions. However, all three classes must follow the General Controls for Medical Devices.
What Are the Classes of Medical Devices? (U.S. FDA)
According to the U.S. FDA CDRH, medical devices are classified into three different groups. As stated earlier, the risk factors associated with the devices determine which category the device falls in. More about these three classes are discussed briefly below:
Class 1 Medical Device: The FDA uses “Class 1 devices” for those that are not directly utilized for supporting life and helps prevent impairment to the patient’s health. And thus, these devices have no potential risk of injury or further illness.
Manufacturers can easily deduce Class 1 Medical Device if the products:
- Do not come in contact with a human’s internal organs.
- Provides negligible impact on the patient’s health.
- Are not necessarily required to sustain the life of patients.
Some examples of Class 1 devices are- Bandages, Electric Toothbrush, Oxygen Mask, Non-electric wheelchair, etc.
Class 2 Medical Device: In accordance with the regulations by FDA, all medical devices must follow a list of General Controls. And while using medical devices, if these general controls are not enough to sustain the safety of patients but do not necessarily act as a life-supporting option, then these can be categorized into “Class 2 Devices.”
The signs of a Class 2 Medical Device are:
- Can come in contact with the patient’s internal organs.
- Can function as a diagnostic tool to determine illnesses.
- No direct possibility of posing a threat to the patient’s life.
Some examples of Class 2 devices are- Syringes, Contact Lenses, Sutures and Blood Transfusion Kits, Surgical Gloves, etc.
Class 3 Medical Device: Devices that directly inhibit major illness or sustain a patient’s life and also have a potential risk of further injury or illness are grouped into “Class 3 Devices.” Most Class 3 medical devices are cutting-edge technology that is essential to partially or fully support a human’s life. Most of these devices are required a 510(k) Clearance before the approval for distribution.
Medical devices can be labeled as Class 3 if they:
- Directly come in contact with the patient’s internal organs and nervous system to support or sustain life.
- Require a delicate observation from skilled individuals when in use.
- Have a possibility of posing a threat to the patient’s life.
Some examples of Class 3 devices are- Defibrillators, Implanted Prosthetics, Ventilators, etc.
Medical Device Classification (European Commission)
Similar to the U.S. FDA regulation, medical devices can also be classified into similar Class I (Also Class Is for sterile devices, Im for measuring function and Ir for reusable), Class IIa, Class IIb and Class III devices for EC. But before classifying them into these three classes, all devices are allocated into four basic categories:
- Non-Invasive: Devices that do not enter the body through an orifice or any surface.
- Invasive: Partially or fully enters the body.
- Active: Devices that need an external source of energy.
- Special: Devices that do not fall under the category of the above three.
Depending on the above basic categories, Class I (Also Class Is for sterile devices, Im for measuring function and Ir for reusable), Class IIa, Class IIb and Class III devices are labeled according to the European Commission. Most of the Non-Invasive devices are Class I with low risk. Class II is further divided into Class IIa and Class IIb, where the former is only for medium risk devices and the latter is for medium/high-risk devices. Class III is only allocated to the highest-risk medical devices.
The medical device classification system by the EC is very similar to the U.S. FDA classification. Henceforth, medical devices usually fall under the same class whether you consider FDA regulations or EC regulations.
How to Determine Your Medical Device Class
All the newly manufactured medical devices must follow FDA-regulated general controls. After clearing these regulations, depending on the medical device classification, additional premarketing applications or clearance are required from FDA. Therefore, to deduce the class of your devices, choose according to the Medical Specialty of your product from the 16 Specialized device classifications.
After entering the Regulation Citation for the specific Medical Specialty category, find the corresponding device code in accordance with the related device. Upon clicking the code, you will be able to determine the class of your medical device.
However, if your medical device is an innovative product and is not available on the above mentioned list, then your product will be classified as a Class 3 device.
For European Commission regulation, first, you need to determine which basic category your device falls under. Then select the most applicable rule to your device under that basic category from EU MDR 2017/745 and deduce the device class in the European marketplace.
In this article, we discussed the FDA classification of medical devices only approved in the U.S and EU. For an international market, you may also have to follow the regulations authorized by “Health Canada” or any other country-specific classification systems. Although, all classifications are similar to some degree.
Upon deducing the class of your medical device, you can now determine if your product is exempt or if a 510(k) clearance is required. In general, most Class 1 and 2 devices are exempt and only need to follow the General Controls provided by FDA. Non-exempt products require a 510(k) clearance before distributing to the market.
For class 3 medical devices, a PMA is required to completely ensure the safety and effectiveness of the manufactured device. Thus, as a medical device manufacturer, it is crucial to know the classes of manufactured devices so that all the required regulations can be complied with before starting to bring the device to the market.
Similar to the FDA, you need to follow EU MDR 2017/745 if you want to distribute your device on the European market. The main difference between FDA and EC regulation is that FDA regulates devices in comparison with already registered medical devices, and EC has specific rules established to classify the devices.
You may go back to our EU MDR guide.