Unwinding Medical Device Classification
Pretam A S.
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In the various posts, there is a lot of information sharing regarding Medical Devices regulations, applications, classification etc. making Medical Devices is basically talk of the town.
Medical devices are instruments, apparatuses, machines, implants, or in vitro reagents that are intended to be used for the diagnosis, prevention, monitoring, treatment, or alleviation of diseases, injuries, or disabilities in humans. These devices can range from simple, handheld tools to complex, sophisticated equipment.
Under International Medical Device Regulators Forum (IMDRF), the Global Harmonization Task Force (GHTF) state that “regulatory controls should be proportional to the level of risk". Medical devices can be classified into several categories based on their purpose, complexity, and level of invasiveness. The classification system varies depending on the country and regulatory authority which plays a crucial role in ensuring patient safety and enabling healthcare professionals to make informed decisions about their usage.
Let's learn about classification of Medical Devices.
Class I Devices
These devices are low-risk and have a simple design. They don't require pre-market approval, and general controls are sufficient to ensure their safety and effectiveness. Examples include bandages, stethoscopes, and tongue depressors.
In European Union (EU), there are three more sub-classifications within Class I medical devices that have a slightly higher perceived risk requiring the involvement of a notified bodies.
Class II Devices
These devices have moderate-risk levels and typically require special controls to ensure their safety and effectiveness which may need pre-market clearance. Examples include X-ray machines, infusion pumps, and hearing aids.
However, European Union does not have generalized category Class II but bifurcated in two more categories.
Class IIa Devices
Class IIa medical devices are considered medium-risk devices by the MDR. This means that unlike a Class I device, the manufacturer must receive a declaration of conformity from a notified body following its conformity assessment. Examples of this risk class include catheters, hearing aids, or short-term contact lenses.
Class IIb Devices
Class IIb medical devices are considered medium- to high-risk devices under the MDR, and also requires the involvement of a notified body. Examples of this risk class includes devices like incubators, insulin pens, long-term contact lenses, and ventilators.
In Russia, United Arab Emirates (UAE), and Australia, Class IIa Devices and Class IIb Devices are also included.
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Class III Devices
These devices pose the highest risk and generally require pre-market approval. They often support or sustain life, and there are no comparable devices on the market. Examples include pacemakers, implantable defibrillators, and artificial hearts.
Class IV Devices
Some countries like Brazil, Canada, Hong Kong, and United Arab Emirates (UAE) have a separate category for the highest-risk devices, which may include innovative and experimental products that are still undergoing clinical evaluation. Examples include pacemakers and surgically invasive devices.
Other Risk Based Classification
India's Central Drugs Standard Control Organization (CDSCO) has the different classes of medical devices based on risk based approach.
Similarly in Middle East country Iran, Medical devices are also classified into four classes A, B, C and D where class A is the lowest and D is the highest level of risk according to the GHTF guidelines.
Australia's Therapeutic Goods Administration have another classification Active Implantable Medical Devices (AIMD) which is an active medical device intended to be totally or partially introduced into the human body for diagnostic or therapeutic purposes under high-risk category however active implantable medical devices will be required to be reclassified from Class AIMD to Class III as per recent updates.
In conclusion, understanding the classification of medical devices is vital for healthcare professionals, manufacturers, and regulatory authorities alike thereby ensuring that medical devices are appropriately regulated, leading to improved patient care, safety, and outcomes.
References
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(Note: This newsletter was created in association with Sahana Shanbhag )
Disclaimer: This article reflects my personal insights and understanding of the topic discussed.? It is not intended to represent the official views of current organization.? This information is shared for educational and discussion purposes only.
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1 年Very nicely classified and well articulated article. Thanks for bringing out this valuable information which would be clear even for a layman and not in medical device industry.