ISO 13485:2016

What is a Class 2 Medical Device?

Understanding Classification, Regulatory Pathways, and Medical Device Exemptions

The world of medical devices is multifaceted, and understanding their classifications is fundamental. In this blog post, we’ll take a deep dive into the realm of Class 2 medical devices. We’ll explore not only what they are but also why they are a critical component of the medical device development industry.

The Class 2 Classification Process and Regulatory Considerations

Class 2 medical devices, in particular, are known for their moderate level of risk. The classification of a device as Class 2 takes into account several key factors:

  • Risk Assessment Based on Potential Hazards: Class 2 devices are those that present a moderate risk to patients. This risk assessment considers factors such as the device’s intended use and potential hazards.
  • Application of Specific Regulatory Controls: To ensure the safety and effectiveness of Class 2 devices, specific regulatory controls and performance standards are applied. These controls may involve design, manufacturing, and quality management.
  • Reliance on Existing Similar Devices (Predicate Devices): Often, Class 2 devices are compared to existing devices known as predicate devices. This comparison helps streamline the regulatory approval process by drawing parallels between the new device and those with a proven track record.
  • Expert Classification Panels for Complex Devices: In some cases, particularly for complex devices, expert panels are convened to assess and classify the device properly. This is done to ensure that the device’s classification aligns with its potential risks and benefits.
  • De Novo Process for Novel Devices without Suitable Predicates: For novel devices that don’t have suitable predicate devices to compare to, the FDA offers the De Novo process. This pathway allows manufacturers to establish the classification and regulatory requirements for their innovative products.

However – successful development of Class 2 medical devices doesn’t stop at regulatory classification. It also involves a holistic approach like Design Thinking. Learn more about the role of Design Thinking in medical device development here.

What are examples of a Class 2 Medical Devices?

Class 2 medical devices encompass a wide range of healthcare technologies, and understanding these examples provides valuable insights into their diversity:

Diagnostic Equipment:

  1. Electrocardiograph (ECG) Machines: These devices monitor and record the electrical activity of the heart, aiding in the diagnosis of various cardiac conditions.
  2. Blood Glucose Monitors: Vital for managing diabetes, these devices allow patients to monitor their blood sugar levels regularly.

Surgical Instruments:

  1. Surgical Scissors: Precision instruments used by surgeons for cutting tissues during surgeries.
  2. Infusion Pumps: Devices that deliver fluids, such as medications and nutrients, to patients intravenously.

Patient Monitoring Devices:

  1. Pulse Oximeters: These devices measure oxygen saturation in the blood, crucial for monitoring patients’ respiratory health.
  2. Continuous Glucose Monitors: Advanced tools for diabetes management, providing real-time glucose level data.

Orthopedic Equipment:

  1. Knee Braces: Designed to support and stabilize the knee joint, aiding in the recovery and rehabilitation of knee injuries.
  2. Spinal Implants: Innovative devices used in spinal surgeries to treat various conditions and injuries.

Software-Based Medical Devices:

  1. Medical Imaging Software: Advanced software used for processing and interpreting medical images, including X-rays, MRIs, and CT scans.
  2. Telehealth Platforms: In recent years, telehealth software has gained prominence, allowing remote healthcare consultations and monitoring.

What are the different premarket submissions for class 2 devices?

If you’re developing a Class 2 medical device, you’ll need to navigate the FDA’s regulatory pathways. There are two primary premarket submission options:

Premarket Notification 510(k):

The 510(k) pathway is commonly used for Class 2 devices. It involves demonstrating that your device is substantially equivalent to a legally marketed predicate device. Key points to consider:

  1. Documentation: Prepare a comprehensive submission package, including device descriptions, intended use, and performance data.
  2. Substantial Equivalence**: Emphasize how your device is similar to the predicate device in terms of materials, design, and intended use.
  3. Performance Testing**: Conduct performance testing to validate the safety and effectiveness of your device.

De Novo:

The De Novo process is suitable for novel devices without appropriate predicate devices for comparison. Here’s what it entails:

  1. Submission: Submit a De Novo request, including detailed information about your device’s design, intended use, and performance characteristics.
  2. Review and Classification: The FDA reviews your submission and classifies your device into Class 1, 2, or 3 based on its risks and benefits.
  3. Establishing Controls: Once classified, the FDA establishes specific regulatory controls for your device to ensure its safety and effectiveness.

Understanding these premarket submission options is crucial for successfully bringing your Class 2 medical device to market.

What device exemptions exist for class 2?

Device exemptions can simplify the regulatory process for certain Class 2 medical devices. Here’s an in-depth look at device exemptions:

Specific Regulatory Exemptions:

Qualifying for Exemptions: Some Class 2 devices may qualify for specific regulatory exemptions. These exemptions are typically granted when the device’s risks are minimal, and additional controls are unnecessary for ensuring safety and effectiveness.

FDA Determination: The FDA determines which Class 2 devices are eligible for exemptions based on their intended use, risks, and historical safety data.

Examples of Exemptions:

Class I Exemptions: Some Class 2 devices may be granted Class I exemptions if they pose minimal risk and meet specific criteria. These exemptions streamline the regulatory process, reducing time and resources required for approval.

Benefits of Exemptions: Utilizing device exemptions can expedite the development, approval, and market entry of Class 2 devices. However, it’s crucial to understand the implications and limitations of these exemptions.

By leveraging device exemptions strategically, manufacturers can navigate the regulatory landscape more efficiently while ensuring their Class 2 devices meet the necessary safety standards.


In conclusion, Class 2 medical devices are a pivotal part of the healthcare industry, offering a diverse range of solutions for patient care and treatment. Understanding their classification, regulatory pathways, and potential exemptions is essential for manufacturers seeking to develop and market these devices successfully. By doing so, you can contribute to advancements in medical technology while ensuring compliance and patient safety.

Post New Nectar logo building
Nectar is an award-winning design & engineering consultancy with a specialization in medical device development. We are proudly 13485 certified, we adhere to the highest industry standards. Nectar has been an industry leader in Southern California for over 25 years. Our proven user-centered design process has facilitated the successful launch of hundreds of products in the market.
Nectar logo color

The news you need to stay on top of cutting edge medical product development.

By subscribing, you acknowledge and agree to Nectar’s Terms of Use and Privacy Policy.


What is a Class 2 medical device?

A Class 2 medical device is a category of moderately risky medical devices that require regulatory controls to ensure their safety and effectiveness.

What are Class 2 medical devices examples?

Examples of Class 2 medical devices include ECG machines, blood glucose monitors, surgical scissors, infusion pumps, and medical imaging software.

What are Class II and III medical devices?

Class II and Class III medical devices are classifications based on risk, with Class II being moderate risk and Class III being high risk.

What are Class 2B medical devices?

Class 2B devices are a subset of Class 2 medical devices with a slightly higher risk profile, necessitating stricter regulatory controls.

Nectar logo color

We are an ISO 13485-certified design and engineering firm based in Southern California, specializing in the development of cutting-edge medical devices.

Our Services
Mechanical engineering, Industrial Design, Software
Firmware, Usability, User interface design, Regulatory

Acumen IQ device in use

Related Blogs

510(k) in Medical Device Development

Understanding the 510(k) Pathway in Medical Device Development

Project Management in Medical Device Development The development of medical devices is a multifaceted and tightly regulated...

Read Now

What the New FDA 510(k) Guidelines Mean for your Product Development

The updated FDA 510(k) guidelines aim to push product developers to embrace the use of newer predicates with higher levels of technology. Read to learn more

Read Now

The Challenges of Medical Device Development: FDA, Regulations, and ISO Certification

Medical Device Development Challenges: FDA, Regulations, ISO

FDA Approval: Medical Device Regulations for Innovation and Patient Safety Navigating the extensive terrain of medical device...

Read Now


Navigating EMI Challenges with IEC 60601-1-2 Compliance

Electromagnetic Interference (EMI) arises when electronic devices encounter electromagnetic fields. EMI affects any gadget with electronic circuitry, and its significance grows with the proliferation of complex electronic devices.

Read Now
image 65

Darren Saravis


Darren is an accomplished, dynamic leader who founded Nectar, X-Naut, and BreathDirect. He is committed to improving the world through the synthesis of technology, science, and art. Under Darren’s leadership, Nectar is leveraging the latest advances in cutting-edge technology to transform medical device development and design. As part of his

image 65 (1)

Steven Wells Ph.D.

Director of Operations

Dr. Steve Wells holds a critical role in steering Nectar’s operations and defining its strategic direction. His impactful leadership has established a clear course for the company’s success. He has revitalized the company with a passion for maximizing impact through expert resource utilization since taking the helm in 2020. Steve has boosted Nectar’s portfolio, streamlined processes, and reinvigorated its innovation agenda, all with the goal of developing life-saving and impactful products. His background in senior leadership roles at Georg Fischer and his people-focused, results-driven leadership style make him an invaluable asset to our team. Steve’s extensive knowledge in chemistry, biocompatibility, and biology only adds to his value as a team member.

image 65 (2)

Nellie Roque

Director of Finance and Accounting

Nellie Roque is a seasoned professional with over 17 years of experience in the fields of accounting, human resources, and payroll. She has a wide range of experience, having worked in industries such as manufacturing, software, and non-profit organizations. Nellie holds a Bachelor’s degree in Business Administration and Accounting, demonstrating her strong foundation in financial management and human resource practices. Throughout her career, Nellie has gained extensive knowledge and expertise in these areas, making her a valuable asset to any organization.
image 65 (3)

John Duval

Principal Engineer

John is a true asset to Nectar, having been a founding member and instrumental in shaping the company’s portfolio and establishing its reputation for engineering excellence. With over 30 patents and numerous design awards to his name, John is a master of product architecture and subsystem integration, as well as design for manufacture, mechanisms, and root cause analysis. His passion for creating simple and holistic solutions that take into account a wide range of variables is evident in his work and has made him a valuable member of the Nectar team.
image 65 (4)

Aaron Gifford

Principal Engineer

With a wealth of experience as a medical device developer, Aaron is a valuable addition to the Nectar team. His expertise in transferring medical devices and IVD instruments to production is unmatched, and his 25 years of professional engineering experience speaks to his expertise. At Nectar, Aaron plays a crucial role in ensuring regulatory compliance throughout product development and manages projects with skill and precision. His recent leadership in the development of the critical care Covid EUA BDR-19™ ventilator is a testament to his abilities, and his 13 patents in the medical device space further highlight his contributions to the field.
image 65 (5)

Larry Larson

Director of Hardware and Firmware Engineering 

Larry Larson is a highly experienced engineering professional who has served as Nectar’s Director of Engineering for several years. He has extensive experience in leading, overseeing, and managing the design and development of innovative products, and has been involved in 70 unique product design cycles to date. With a deep understanding of highly regulated industries such as medical and aerospace devices, Larry has been instrumental in bringing cutting-edge technologies to market and delivering solutions that meet the needs of his clients. He has a passion for engineering and is dedicated to advancing the field by delivering products that are safe, effective, and of the highest quality.
image 65 (6)

Adam Marten

Senior Mechanical Engineer

Adam Marten has worked in the aerospace and consumer products industries since 2006 with lead engineering experience in conceptual design, product development, analysis and performance qualification testing. Adam has experience leading a range of technical projects, including multiple structural analyses for military and aerospace applications. He has also worked directly with engineering teams to develop medical devices and laboratory instrumentation.

image 65 (7)

James Wilkin

Industrial Design Manager

James is a seasoned professional with over seven years of experience at Nectar, where he brings his expertise in industrial design, user interface, and user experience to the table. With a background in the highly competitive automotive industry, working for heavyweights like Daimler and Tesla, James is a true asset to the Nectar team. He is responsible for ensuring that the company adheres to user-centered design best practices, and he works closely with clients and partners on crucial human factors strategies for FDA submissions and the overall usability engineering process. James’ achievements in this field speak to his exceptional skills and dedication to the work he does.
image 65 (8)

Rejsa Kuci

Business Development Coordinator

Rejsa is a dynamic force in driving sales and acquiring new projects at Nectar, where she excels in seamlessly aligning the Sales and Operations teams. Holding a prestigious double degree from the Rochester Institute of Technology in Management and Multimedia, Rejsa brings a wealth of experience to her role as a Project Manager, Digital Marketing Strategist, and Creative Lead. With over four years of expertise in the digital world, Rejsa is not only highly skilled but also enthusiastic about following the ISO 13485 path to ensure successful project completion. Her ability to effectively bridge the gap between Sales and Operations, combined with her passion for driving projects forward, makes her an invaluable asset to the Nectar team.
image 65 (9)

Belen Quintero

Associate Project Manager

Belen is a project manager at Nectar who brings a wealth of experience and expertise to her role. With a strong background in Mathematics and Philosophy from the University of California, Riverside, she has honed her skills in a variety of industries including healthcare ,education, food manufacturing, and engineering. Belen’ success as a project manager is due in large part to her ability to align projects with business goals, clearly define project needs, lead cross-functional teams, and effectively communicate results to stakeholders. With her proven track record of success, Belen is a valuable asset to the Nectar team and a key player in driving the company’s projects forward.
image 65 (10)

Erjon Ameti

Mechatronics Engineer

Erjon Ameti is a highly knowledgeable Mechatronics Engineer with a wealth of experience in both academic settings and startup environments. With a strong background in electronics, robotics, and 3D modeling, he possesses a unique combination of skills that allow him to excel in the fields of automation systems and mechatronics. Over the past five years, Erjon has honed his expertise in product development and industrial automation, emerging as a leading authority in his field. Currently, Erjon works at Nectar as a hardware engineer, where he is responsible for documentation, CAD design, and electronics in general. He has been involved in the entire process of Nectar engineering, bringing his expertise and experience to the forefront of the company’s success.
image 65 (11)

Redon Berisha

Electronics Engineer

Redon is a highly skilled engineer with a passion for technology and innovation. He has a background in mechatronics, which has given him a strong foundation in electronics, including electronic design, PCB design, and cable design. Redon excels in the critical components of the design process, including documentation for assemblies, testing, debugging, and ensuring each project is completed to the highest standard. At Nectar, he plays a crucial role in the creation of cutting-edge technology, bringing his unique vision to life and making him a valuable member of the team. With his technical expertise and creative vision, Redon is a leader in the field of electronic design.
image 65 (12)

Kerry Eiss

Clinical Expert - RN, BSN, CLNC

With over two decades of experience in healthcare innovation, Kerry has been instrumental in transforming patient care and improving patient outcomes across the globe. Her extensive knowledge and expertise in the cardiovascular and cardiothoracic operating room, as well as her experience in emergency medicine, geriatrics, pediatric psychiatry, and main OR, make her a versatile and valuable member of the team. From small hospitals to large teaching institutions, Kerry’s 20 years of experience with patient documentation, including the use of EPIC, Cerner, and Meditech electronic charting systems, have positioned her as a leader in her field. Her recent involvement in helping transition the Providence St. Vincent Medical Center’s Cardiac Surgery program from paper charting to electronic documentation further underscores her commitment to advancing the healthcare industry.

image 65 (13)

Flaka Brahimi

Marketing Manager

Flaka, a highly skilled professional with a background in Architecture and Spatial Planning from the University of Business and Technology in Pristina, holds a dual role at Nectar as both the Marketing Project Manager and a valuable member of the Business Development team. In her role as Marketing Project Manager, she is responsible for overseeing the development and execution of marketing strategies and as a member of the Business Development team, she actively contributes to the growth of the company by assisting in the creation of impactful marketing tactics. With her diverse background and expertise, Flaka plays a crucial role in ensuring the success of Nectar’s projects.
image 65 (14)

Brayton Hammerli

User Experience Designer

Brayton is a multi-disciplinary designer with a A.A in Studio Arts and a B.S in Industrial Design from California State University Long Beach. As a user experience designer, Brayton specializes in usability evaluations, user research, feedback studies, GUI design, mobile app design, human factors evaluations, and formative studies. In his free time, Brayton enjoys outdoor activities such as hiking, mountain biking as well as other creative pursuits. He approaches problems with a solution-focused mindset and enjoys exploring ideas. 
image 65 (15)

Stephanie Rodriguez

Accounting Coordinator

Stephanie Rodriguez is a highly experienced administrative professional with over 10 years of expertise across a diverse range of industries, including contract manufacturing, financial and wealth management, and the medical field. She holds a Bachelor’s degree in Humanities from Northern Arizona University. As a valued member of the Nectar team, Stephanie plays an integral role in supporting the engineering teams by acquiring materials and parts for the prototype phase of our clients’ projects. She also assists the Director of Accounting by issuing purchase orders and provides project managers with accurate data to effectively manage and track budgets for each stage of the statement of work. Stephanie’s knowledge and skills, combined with her dedication and drive, make her an asset to Nectar and a key player in ensuring the successful completion of our projects.
image 65 (16)

Toska Ukaj

Scientific Content Writer

Toska Ukaj is a gifted writer who brings a wealth of expertise and passion to Nectar. With a background in medical science and years of experience producing high-quality scientific and medical publications, Toska’s writing skills are unparalleled. She boasts an excellent educational record, advanced interpersonal skills, and a deep passion for healthcare. As Nectar’s writer, Toska consistently produces clear, concise pieces that can be easily understood by the public and truly captures the essence of Nectar’s mission. With her exceptional writing abilities and commitment to healthcare, Toska is an invaluable asset to the Nectar team.
image 66

Sean Wells

Mechanical R&D Technician

Sean plays a critical role at Nectar. He has a wide range of skills that help keep the company and equipment running. His background in machine and building maintenance means he has skilled hands ready for anything. Sean runs our lab equipment including 3D printers and a laser cutter. He also helps with complex project builds, assemblies, and testing.
image 65 (18)

Jonathan Cantera

Quality Manager

Jonathan at his core is a Human Factors Engineer with his M.S. in Human Factors and Minor in Sociology from California State University of Long Beach. At Nectar, Jonathan is responsible for managing and maintaining the company’s ISO 13485 Quality Management System keeping in compliance with US and international regulations for product development. Jonathan’s role ensures each department is in compliance every step of the design process, making him a critical Nectar team member. Jonathan’s Human Factors background also allows him to aid in user research, feedback sessions, usability evaluations, and formative studies such as risks assessments. When he’s not in the office, Jonathan enjoys film photography, and reading.

Vesa Hyseni

Purchasing Manager

Vesa is a skilled Purchasing Manager with a strong focus on procurement strategies and vendor management. With a track record of successfully leading procurement teams, Vesa excels in optimizing procurement processes, consistently striking a balance between quality assurance and cost-effectiveness. Her ability to identify cost-saving opportunities and manage supplier relationships effectively makes her an indispensable asset to Nectar.

Uran Çabra

Software Engineer

Uran Çabra, with a background in Mechatronic Systems Engineering, has been working on Embedded Systems, specifically on IoT product development. His responsibilities include firmware development and electronics design and testing. He holds a master’s degree in Electrical Engineering with a focus on Autonomous Mobile Robotics.

Sarah Clark

Industrial Designer

Sarah has a background in fine art & graphic design with a B.S in Industrial Design from California State University Long Beach. As a user experience designer her specialties include: keen aesthetics, creative problem solving, a detail oriented approach to research, and improving user journeys within complex experiences.