In the process of putting a medical device or an IVD product on the market, one of the first and most important steps is correctly identifying its risk classification. In a nutshell, medical device classification is a regulatory process used in categorizing medical devices based on their intended use, as well as potential risks to users and patients. With over 500,000 types of medical devices, the risk classification establishes a system that regulatory authorities, manufacturers, and healthcare professionals can use to assess the safety, reliability, and effectiveness of these medical devices. For manufacturers, this is also one of the most important steps, as it also sets the direction of your CE-marking process.
While it may sound simple, the classification criteria are complex and highly specific, and companies, especially startups, are still facing challenges in properly identifying the correct classification of their medical device. Moreover, in 2021, the Medical Device Regulation (MDR) fully replaced the Medical Device Directive (MDD). A year later, the In Vitro Diagnostic Directive (IVDD) was replaced with the In Vitro Diagnostic Regulation (IVDR), introducing a new and more stringent system of classifying medical devices. This also means that previously CE-certified medical devices must be updated in accordance with the new regulations.
As previously mentioned, identifying the correct medical device risk classification is one of the first steps in the certification process. By doing so, medical device companies are given a direction and a pathway in the regulatory compliance process. Depending on the risk classification of a medical device, additional requirements may also need to be prepared and produced, and correctly identifying the medical device classification can help in meeting regulatory compliance for medical devices as seamlessly as possible.
Failing to correctly identify the classification of a medical device can lead to challenges in regulatory compliance, ultimately delaying the introduction of the product to the market as risk classification determines the notified body involved, which especially changed for IVDs with the introduction of the IVDR.
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Generally, the classifications of medical devices are determined by the intended purpose of the device and the potential risks posed by the device to patients and users, among other factors, concluded by the invasiveness of the device and the duration of contact of the device with the human body. Here is a brief overview of how these factors can affect the classification of a medical device:
● Body contact duration – Some medical devices are intended for short-term contact, while some are meant for long-term contact, or even permanent implantation. These are all considered by the MDR in determining the classification of a medical device.
● Invasiveness – Another factor considered by the MDR in classifying a medical device is its invasiveness. An invasive medical device penetrates the body, while a non-invasive device does not penetrate the body.
● Active vs non-active medical devices – Active medical devices are generally powered and require an energy source, while non-active, or passive medical devices do not require one. In considering these for the classification of a medical device, active devices typically require more scrutiny and may have a higher risk classification.
● Measuring function – Devices that are designed and intended to measure a physiological function may also be subject to different and specific classification rules, depending on their measuring function.
These are just some of the factors that the MDR considers in the classification of a medical device. Since the criteria can be very detailed and intricate, medical-device companies may also seek guidance and expert advice from consultants to ensure accurate classification of their medical devices. Moreover, modern tools, such as easily accessible AI-powered services, are available today, and can help companies in classifying their medical devices.
Medical devices are grouped into four classes. known as I, IIa, IIb and III. and in vitro diagnostic medical devices are grouped into A, B, C, D, with Class I and A being the lowest risk and Class III and D being the highest risk, respectively.
Class I – Class I devices are generally considered low-risk devices and do not require the involvement of a notified body. Examples include bandages, corrective spectacle frames and lenses, and wheelchairs. Class I devices in a sterile condition, with a measuring function, or are reusable surgical instruments, have an increased risk posed to the user and require oversight by a notified body.
Class IIa – Class IIa devices are moderate-risk devices. Some examples are needles or syringes, surgical gloves, or electrically powered devices for diagnosis and monitoring.
Class IIb are higher risk devices compared to Class IIa. These devices are subject to more stringent regulatory requirements and typically require a more thorough assessment by a notified body. Some examples include pacemakers, defibrillators, as well as orthopedic implants.
Class III devices have the highest risk associated with them due to their use, as they typically sustain or support life. Some examples include ventricular assist devices, implantable cardioverter defibrillators (ICD), and advanced life support machines.
Given the complex nature of the classification of medical devices, companies may also seek the expertise of consultants to ensure accurate classification of their medical devices. With the more stringent regulatory requirements brought about by the MDR and IVDR, the process may seem initially daunting, especially for startups.
It is also worth noting that the correct classification of your medical device is just among the first steps of a long and potentially tedious regulatory compliance process. Depending on the classification of your medical device, the regulatory compliance process may require you to prepare complex and detailed technical documentation. If deemed necessary, you may also have to collect additional clinical data.
Consultant companies, such as Key2Compliance, can help in making this process as seamless as possible.
Correctly identifying the classification of your medical device should be the first step in the regulatory compliance process, as doing so will prevent any unnecessary challenges along the process. Key2Compliance can help you not only in classifying your medical device, but throughout the whole regulatory process, including compliance maintenance. We have also developed an easy-to-use AI-tool that can help you in identifying the classification of your medical device!
The team of experts of Key2Compliance come from different backgrounds in the healthcare and medical device industry, allowing us to provide personalized guidance and specific expert advice to help you obtain the CE-marking for your device. Additionally, we also offer expert guidance for the new IVDR.
Interested in learning more about how we can help you? Contact us!
The CE mark indicates that a product meets the applicable EU laws and allows the manufacturer to make their device available on the European market. Navigate the complexities of obtaining a CE mark for your medical device with our guide.
In this guide, you will find:
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