As we know, the healthcare system and medical devices are co-dependent. The safety and effectiveness of medical devices matters when they are broadly used for the well-being of human health. The regulators have classified medical devices based on their proportionate risk. So that they can satisfy all the requirements set forward by the authorities to demonstrate that it is safe and effective. Know more about classification of medical devices.
What Is A Medical Device Classification?
Medical device classification is the classification of medical devices based on certain criteria. The regulatory bodies classify medical devices based on the risk potential it can have for any of the purposes it is intended for.
Types of Medical Devices
Medical devices are all the technologies for health, excluding medicine and vaccines, that are used for the purpose of preventing, diagnosing, treating, monitoring, rehabilitation and to provide palliative care to the patients. Medical devices are of a wide variety and out of which some types of medical devices used are:
Single Use Devices
Single use devices or SUD’s are the medical devices which are meant for one time use. In other words, it is intended for use in a single patient during a single procedure. E.g. Syringes, Catheters.
Implantable Medical Devices (IMD)
These are devices which are implanted or inserted into a person for treating a medical condition. It can be permanent or semi-permanent. In most cases, implants are introduced into the body by means of a surgical procedure. E.g. Hip prosthesis Pacemakers
Imaging
Medical imaging devices are those which are developed to view the body for the purpose of diagnosing, monitoring or for treating medical conditions. E.g. MRI, X-ray machine.
Medical Equipment
These are equipment used to monitor, diagnose or treat a medical condition. Implantable devices, disposable or single use medical devices are excluded from this category. These devices need calibration, maintenance, repair, user training and decommissioning activities which are usually managed by clinical engineers. E.g. Anesthesia machines, patient monitors, hemodialysis machines.
Software as a Medical Device (SaMD)
International Medical Device Regulators Forum (IMDRF) states SaMD as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device. It can range from software that can be used to view the MRI scan via a smartphone for diagnosing to computer aided detection software that helps detect breast cancer via image postprocessing. E.g. Computer aided diagnostics
In vitro diagnostics (IVDs)
In vitro diagnostics (IVDs) devices are tests done which have the potential to detect disease, conditions or infection. These tests are usually performed on blood, urine or other human samples. These tests can range from being performed in a laboratory or professional setting to the comfort of home. E.g. Glucometer, HIV tests
Personal Protective Equipment (PPE)
These are types of equipment meant to protect a person from injury or from the spread of an infection or an illness. E.g. Mask, Gowns, Gloves, etc.
Surgical And Laboratory Instruments
Surgical instruments are those which are used to perform surgery while laboratory instruments are used to perform scientific experiments which aid in the detection, monitoring and treatment of a medical condition. E.g. Forceps, Suction tube (Surgical), Microscope, Autoclave (Laboratory).
Types Of Medical Devices Based On Classification
Class I Medical Devices: These are medical devices that have low or low to moderate risk of causing harm to the patient for its intended use. E.g. Enema kits, Elastic bandages
Class II Medical Devices: Medical devices coming under this class are those which have moderate to high-risk potential to harm the patient for its intended use. E.g. Powered wheelchairs, Contact lens
Class III Medical Devices: Medical devices that possess a high risk of harm for its intended use to the patient. E.g. Pacemakers, Heart valves
How Are Medical Devices Classified?
For FDA, to classify a medical device, regulation number or the classification regulation for that particular device must be found. This can be found either by searching with the name of your device or by knowing the medical specialty (device panel) to which the device belongs. If later is the case, then the corresponding regulation can be found by identifying the device from the listing for that panel.
You can directly refer to the Code of Federal Regulations (CFR) if the appropriate panel is known. Now you can find the device classification from the list of classified devices. In CFR, each classification panel starts with a list of devices which are classified in the panel. Once the device is found in the list, device description and class is also found in the section (E.g. 21 CFR 880.2920) indicated.
Approximately 74% of class I devices are excluded from needing a premarket notification. In 21 CFR, classification regulation, the exemptions are given. 513 (g) request can be submitted for a formal device classification from FDA.
In the EU, the classification of medical devices is detailed in the MDR 2017/745. In article 51 of the MDR it is described that the classification is carried out in agreement with the classification principles laid down in Annex VIII of MDR regulation.
Global Variations in Medical Device Classification System :
EU Medical Devices Types
In the EU, according to the classification rules, medical devices are classified into four groups depending on the risk at the time of use. They are I, IIa, IIb and III
CLASS | RISK CLASSIFICATION |
CLASS I | Low risk, Noninvasive |
CLASS Is | Device to be marketed in sterile condition under class I |
CLASS Im | Devices with measuring function under class I |
CLASS Ir | Reusable surgical instruments under class I |
CLASS IIa | Low to medium risk. For devices installed in the body for a short term (60 min to 30 days). |
CLASS IIb | Medium to high risk. For devices installed in the body for 30 days or more. |
CLASS III | High Risk |
FDA Medical Devices Types
As per FDA, the medical device classification system is as follows: -
CLASS | RISK |
CLASS I | Low to moderate risk |
CLASS II | Moderate to high risk |
CLASS III | High risk |
For FDA and EU, the medical devices are broadly classified as Class I, II and III. But for the EU, classes I and II are again divided, which can be seen in the table above. To both the regulatory bodies, class I is for medical devices that possess low risk. Similarly, class III is for devices with high risk. More devices are in class I and III for the EU when compared to the US. However, for the US, more devices fall under class II in comparison to the EU. Different notified bodies are accountable for medical device approval whereas in the US, FDA is the centralized authority.
Regulatory requirements needed for each class of medical devices vary for FDA and EU. For example, premarket approvals, conformity assessment test compliance is important for class III devices for FDA and EU respectively.
Factors Influencing Medical Device Classification
Main factors influencing the classification of medical devices are:
Based On | Factors Influencing |
Device | Device contact duration, invasiveness degree, Does the device deliver medicinal products or energy, is it intended to bring a biological effect on patients. |
Manufacturer’s Intended Purpose | Does 2 or more classification rules apply |
Assemblage of medical devices | Combination resulting product is used for a different purpose than it is intended for, Combination resulting product used for its intended purpose. |
Software | Software driven/ influenced medical device, Software that is independent of medical device, Is software deemed to be an active device. |
If 2 or more classification rules apply to the device, based on the manufacturer’s intended purpose, then the device is placed to the highest level of classification indicated. If one medical device is used together with another medical device the classification rules apply to each of the devices separately.
For classifying an assemblage of medical devices in which each of them comply with all the regulatory requirements, depends on the purpose of the manufacturer in packaging and marketing of that combination the separate devices.
Consider that the combination results in a product which is intended by the manufacturer to serve a different purpose from that to the individual devices which make up the product. In such cases, the combination is a new device and will be classified based on its new use. Now, if the combination is for the user convenience and does not change its intended purpose of the individual medical devices which make it (E.g. a customized kit which is designed to carry out a surgical procedure). The classification in which this assemblage comes under will be the highest class of the device included in it.
Accessories that are meant to be used with the parent medical device for attaining its intended use, must comply with all requirements (Principle of safety and performance, Post marketing surveillance, etc.) for the parent medical device as well. For the purpose of classification, the accessory will be counted as a medical device.
The regulatory requirements for medical devices needed to comply with health authorities can differ with the regulatory authorities. This is a challenging step for manufacturers seeking the approval of medical devices. Artixio Consulting has a team of regional experts and experienced leaders in the field of medical devices that can lead you down the right path. Connect with us at info@artixio.com
FAQs:
Q. What are the different classes of medical devices?
There are 3 classes of medical devices. They are Class I, Class II, Class III. Each medical device belongs to each of these classes based on the risk level they exhibit for the use it is intended for.
Q. Why is medical device classification important for manufacturers?
It is important for manufacturers because for the approval of these devices the manufacturers need to demonstrate the safety and effectiveness of the device. Each class contains separate requirements and conformity tests for safety assessment. Out of all classes, class III has stringent regulatory requirements.
Q. Are medical devices classified differently in the EU and US?
Yes, Medical device classification is different for EU and US. In the EU, they are classified into 4 categories (Class I, Class IIa, Class IIb and Class III) whereas in the US, medical devices are classified into 3 (Class I, Class II and Class III).
Q. What happens if a medical device is incorrectly classified?
If a medical device is incorrectly classified, the conformity tests needed to be performed to demonstrate the safety and effectiveness of the device, quality tests and standards that need to be satisfied, documents needed to be submitted, all these will turn into incorrect or incomplete data. This ultimately delays the regulatory approval process of the medical device.
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