Class I, Class II, Class III Medical Devices
All Medical Devices are classified according to 3 main classes, Class I, Class II, and Class III regulated by the U.S. Federal Drug Administration (FDA) before issuing to the patient for use. These Medical Devices are classed according to the device risk depending on the device invasiveness and impact on the patient’s overall health.
By understanding the difference in the classes of the Medical Devices, you can understand the criticality of the use. To ensure the safety on which the public can rely without questioning every Medical device is determined by Food and Drug Administration to ease the streamlined process. Medical device manufacturers selling globally need to familiarize themselves with the applicability of the Classes under regulations of the FDA to place the devices in markets. To achieve the devices free from errors and safety an organization can adopt ISO 13485 Certification. Achieving this ISO 13485 certification helps to differentiate the devices according to the classes and other compliance of the local law and regulations.
According to ISO 13485 Certification the devices are classified into the different device panels by finding the matching description of the device in Title 21 of the Code of Federal Regulations (CFR), Parts 862-892. Over 1700 types of devices are organized into different 16 medical specialties “panels” such as cardiovascular devices or Ear, Nose, and throat devices, dental floss, and enemas. The European classification system is based on the Regulation (EU) 2017/745 for Medical Devices and Regulation (EU) 2017/746 for In Vitro Diagnostic Medical Devices.
The MDQMS based on ISO 13485 Standard is established based on such classifications. The extent of controls exercised during manufacturing and the subsequent processes until the administration of the product in its intended use, are proportional to the degrees of risks based on which the classification of the device is done.
Class, I devices are low-risk devices that require the least amount of regulatory control. These devices have a simple design, easy and safe to use. Types of Class I medical devices include tongue depressors include bandages, and nonelectric wheelchairs and surgical instruments, and gauze. Class I devices are of the lowest risk of all devices and require less regulatory compliances as compared to other classes of medical devices. A premarket notification application and FDA clearance are not required for Class I devices before marketing the device in the U.S. Similarly, in EU classification system, the Class 1 devices do not mandatorily require intervention by the EU Notified Bodies. However, the manufacturer is just required to register and establish and list their generic product with FDA. Today about 47% of the medical devices come under the Class I category and about 95% are exempted from regulatory compliances of law or particular standard.
Class II devices are more complicated than class I devices. They are moderately risky because they are more likely to come into sustained contact with a patient. These devices come in direct contact with the patient/user. The class II devices aim at focusing the sustained equivalent in the devices by adopting a 510K review. The devices should comply with the controls prescribed by the regulation set by FDA or the specific standard. These types of devices include heart-rate monitors, powered wheelchairs, condoms, pregnancy kits, etc. The European classification system however, uses a sub-classification system i.e. Class IIa and Class IIb. Majorly, the Class IIa devices do not require a mandatory intervention by the EU Notified Bodies. However, it is important that the product be accessed through an expertized organization like Ascent, before the manufacturer proceeds further to select the correct conformity route.
Class III medical devices are considered high-risk devices. These devices usually sustain or support life by implanting in the patient’s body or present potential unreasonable risk of illness or injury. They usually consist of 10% of the total medical devices regulated by the FDA.
How to determine and classification of the Medical Devices?
To determine the right category of classification for your device, you can go directly to the CFR and find the classification for your device. However, it is recommended that the services of an expertized organization like Ascent WORLD be taken to ensure that the decisions don’t go wrong and the project does not end up in unnecessary expenditures. Alternatively, you can use the keyword directory in the PRODUCT CODE CLASSIFICATION DATABASE. Each classification panel in the CFR has a 7-digit number associated with it, e.g., 21 CFR 880.2920 – Clinical Mercury Thermometer. Once you have identified the correct classification, go to the CLASSIFICATION PANELS and click on the correct classification, to check the excepted devices from the premarket notification process. For further information, you may view the CDRH Learn training module entitled 513(g) Requests for Information for further detailed study of Medical Devices.
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