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FDA & EU Medical Device Classification Guide: How to classify your Medical Device?

In Medtech and Healthcare technology the introduction of groundbreaking medical devices is revolutionizing patient care. However, overcoming the regulatory burden is a huge challenge.

Leverage this guide as you work your way through the intricate journey of the Medical Device Classification process. We'll shine a light on the pivotal factors dictating the regulatory pathway for each medical device. Whether you're a seasoned tech industry pro or a newcomer with a disruptive vision, this guide is designed to demystify the classification process. This guide is your ticket to mastering the regulatory landscape, ensuring the seamless and secure deployment of medical devices.

Join us as we decode the tech-centric language of regulations, empowering you to drive innovation and elevate patient outcomes between the USA and Europe in the ever-evolving Medical Device Classification landscape.

Medical Device Classification in the US and EU

Medical device classification in the United States (US) and the European Union (EU) follows distinct regulatory frameworks, each with its own set of guidelines and requirements. You can also always refer to the MDCG 2021-24 Guidance on classification of medical devices for further insight & information for classification in the EU. For the US, you can also find the key guidance here.

United States Medical Device Classification (US)

In the US, the classification of medical devices is overseen by the U.S. Food and Drug Administration (FDA). The FDA classifies medical devices into three main classes - Class I, Class II, and Class III - based on the level of risk they pose to patients and users.

  1. Class I: Devices with low to moderate risk, such as bandages and tongue depressors, often subject to general controls.

  2. Class II: Devices with moderate risk, including non-invasive diagnostic devices and some surgical instruments, subject to special controls and may require 510(k) clearance.

  3. Class III: Devices with the highest risk, such as certain implantable devices, undergo the most rigorous regulatory scrutiny, requiring pre-market approval (PMA).

European Union Medical Device Classification (EU)

In the EU, the classification of medical devices is outlined in the Medical Devices Regulation (MDR). The classification is based on factors like intended use, duration of use, and whether the device incorporates medicinal products.

  1. Class I: Low-risk devices with a basic design and intended for short-term use, often subject to self-certification by manufacturers.

  2. Class IIa, IIb: Moderate to medium-high risk devices, subject to conformity assessment procedures, and may require involvement of a Notified Body.

  3. Class III: High-risk devices, including implantable devices, typically undergo a conformity assessment by a Notified Body.

How to classify your medical device. Medical Device classification imageImage Source: EC Europa MDCG 2021-24 Guidance on classification

An example is shown above in the image on non-invasive medical devices. It highlights different practical use cases that should be considered when reviewing the class of your medical device.

Both the US and the EU emphasize the importance of risk-based classification, but the specific criteria, regulatory pathways, and involvement of regulatory bodies differ. Manufacturers aiming to market medical devices in both regions need to navigate these regulatory landscapes effectively to ensure compliance with the respective requirements.

Why is Medical Device Classification Important?

Medical device classification is critically important for several reasons, as it is a fundamental aspect of the regulatory framework, plays a pivotal role in safeguarding public health, facilitating innovation, and ensuring the integrity of the medical devices market.

What does all of that mean for Medical device classification, in simple terms?

  1. Classification provides regulatory oversight which helps to determine the level of regulatory scrutiny and control that a medical device will undergo before entering the market. 

  2. The classification system is designed to assess the potential risks associated with different medical devices. Higher-risk devices, classified as Class II or Class III, undergo more rigorous regulatory processes to mitigate potential dangers to patients and users.

  3. Each class has specific requirements for pre-market submissions. Understanding the classification is essential for manufacturers to navigate the appropriate approval process, such as pre-market notification (510(k)), pre-market approval (PMA), or exemption from pre-market notification.

Classification influences post-market surveillance requirements. Oftentimes, higher-risk devices have more robust post-market surveillance obligations to monitor their ongoing safety and effectiveness.

The primary goal of medical device classification is to ensure the safety and effectiveness of devices used in healthcare. Proper classification helps prevent the introduction of unsafe or ineffective devices into the market, protecting patients and healthcare practitioners. Healthcare professionals, purchasers, and users rely on device classification information to make informed decisions. Knowing the classification helps them understand the level of regulatory scrutiny a device has undergone and its potential risk profile.

Innovation In the Medical Device Classification Process

In recent years, both the European Union (EU) and the United States (US) have undergone significant transformations in their approaches to the medical device classification process, reflecting a commitment to fostering innovation in healthcare technologies.

United States (US)

In the US, the FDA has proactively embraced the era of digital health technologies. The Software as a Medical Device (SaMD) paradigm is a testament to this shift, recognizing the unique challenges posed by software-based medical devices and offering a more flexible approach to their regulation. This acknowledges the dynamic nature of digital health innovations, allowing for a regulatory framework that can adapt to rapid technological advancements.

By prioritizing and accelerating the approval of devices addressing critical unmet medical needs, the FDA encourages manufacturers to push the boundaries of innovation in the medical device industry.

European Union (EU)

In the EU, the risk classification system has been introduced to align with the evolving landscape of medical technology. This system emphasizes a risk-based approach, recognizing that not all devices pose the same level of risk to patients. It provides a more nuanced framework for classifying medical devices based on factors such as technological complexity, duration of contact with the body, and potential harm, allowing for a tailored regulatory approach.

Additionally, the implementation of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) signifies a comprehensive effort to enhance transparency and accountability in the medical device approval process within the EU. This regulation imposes stricter requirements on clinical evidence and post-market surveillance, contributing to a more robust and vigilant ecosystem for innovative medical technologies.

In both the US and the EU, these innovations in the medical device classification process underscore a commitment to balancing the promotion of technological advancements with the critical need to ensure patient safety and efficacy. The evolving regulatory landscapes in both regions reflect a dynamic response to the challenges and opportunities presented by a rapidly advancing healthcare technology landscape.

How to classify your medical device in one class?

To classify your medical device into one of the three FDA classes (Class I, Class II, or Class III) or EU MDR/IVDR (Class I, Class IIa, IIb, Class 3) follow these key steps below.

Additionally, engage in open communication with regulatory authorities, seeking their guidance throughout the classification process. Regular interactions with regulatory experts can provide valuable feedback, ensuring alignment with current standards and regulations, and enhancing the overall success of your device in the market.

  1. Define Intended Use and Functionality: Clearly articulate the primary purpose and functionality of your medical device. Understand how it will be used in a clinical setting, emphasizing its intended impact on patient care and treatment modalities.

  2. Benchmark with Similar Devices: Identify and analyze existing devices in the market that share similarities in terms of technology, intended use, and risk profiles. This benchmarking process provides valuable insights into the classification of your device.

  3. Utilize FDA or MDR Guidance Documents: Thoroughly review relevant FDA & MDR guidance documents that relate to the classification of medical devices. These documents offer specific criteria and considerations for classifying various types of devices, providing a regulatory roadmap.

Simplify the classification of medical devices with Matrix Requirements

Simplify the classification of medical devices with Matrix Requirements QMS, a robust and user-friendly platform designed to streamline the complex process of Medical Devices and getting them to market faster. Matrix Requirements provides a solution for Medical Device manufacturers, RAQA Managers, Developers and healthcare professionals to ensure the Medical Device Classification Process and Audit goes smoothly.

Matrix Requirements facilitates collaboration with regulatory experts, offering a seamless avenue for open communication and ensuring that all the required documentation helps get the Medical Device to market, thus in turn helping in the Medical Device Classification process. By utilizing this QMS, users can navigate the intricacies of medical device classification with confidence, promoting regulatory compliance and accelerating the journey from concept to market.

Futhermore, we encourage our readers to review the MDCG 2021-24 Guidance on classification in the EU or the US, you can also find the key guidance here to ensure you don't miss any updates and you classify your Medical Device correctly. As a RAQA manager it's time to take ownership!

About the Author
Adam Newman
Head of Marketing