EU MDR Medical Device Classification: Classes, Examples

The European Union Medical Device Regulation (EU MDR) categorizes medical devices into one of four classes: Class I, Class IIa, Class IIb, and Class III medical devices. The MDR medical device classification is based on the device’s potential risk of harm to users.

Examples of EU MDR Class I medical devices include hospital beds, corrective glasses, and thermometers. MDR Class IIa medical devices contain catheters, hearing aids, and surgical clamps. MDR Class IIb medical devices contain contact lenses, surgical lasers, and defibrillators. MDR Class III medical devices include hip-joint implants, prosthetic heart valves, and aneurysm clips.

The EU MDR, officially known as Regulation (EU) 2017/745, outlines 22 rules to guide the appropriate categorization of medical devices based on their potential risks and intended use.

Resembling the EU MDR, the United States Food and Drug Administration (FDA) also classifies medical devices based on their potential risk to safety. However, instead of 22 specific rules, the FDA uses risk classification and comparisons to similar devices already in the market.

Each EU MDR class establishes specific regulatory requirements medical devices must comply with, from self-declaration of conformity to periodic safety update reports. Accurately classifying a device ensures following the right approval pathway, saving time and resources.

Quality Management System (QMS) software facilitates the approval process for medical devices under EU MDR. Medical device companies are adopting QMS solutions to streamline quality management, increasing the chances of successful device approval in the European market.

SimplerQMS is a fully GAMP 5-validated QMS software designed to meet the unique needs of medical device companies. Discover how our software streamlines quality management processes and book a demo with one of our quality solution experts.

We will discuss the following topics in more detail:

• What Are EU MDR Medical Device Classes?
• What Is an EU MDR Class I Medical Device?
• What Is EU MDR Class IIa Medical Device?
• What Is EU MDR Class IIb Medical Device?
• What Is EU MDR Class III Medical Device?
• How To Classify Your Medical Device According to EU MDR Classification Rules?
• What Is the Difference Between EU MDR and FDA Medical Device Classification?
• What Are the Different EU MDR Medical Device Regulatory Approval Pathways?
• What Is the Role of eQMS in Facilitating EU MDR CE Marking Regulatory Process?

What Are EU MDR Medical Device Classes?

The EU MDR categorizes medical devices into four classes: Class I, Class IIa, Class IIb, and Class III.

Medical device classes are determined by the potential risk of harm the device presents to the user.

Determining the class of medical devices under the MDR involves following the 22 classification rules outlined in Annex VIII. These rules are a structured approach to assessing the potential risk posed by a device based on various factors.

The risk posed by the device to safety outlines the four classes as follows:

• Class I: Class I medical devices pose a minimal danger to patients and are primarily used for non-invasive procedures and basic functions.
• Class IIa: Class IIa devices have a higher risk potential than Class I but remain moderate.
• Class IIb: Class IIb devices fall between Class IIa and III, posing a significant risk but not as high as life-supporting or long-term implantable devices.
• Class III: Class III medical devices pose the highest potential risk, often supporting vital functions, being implanted for long periods, or used in critical procedures.

The MDR considers body placement and intrinsic characteristics for device classification, as mentioned below.

• Non-invasive: Non-invasive devices work outside the body. Non-invasive devices generally pose lower risks and fall under Class I or Class IIa medical devices, according to the MDR. Examples of non-invasive medical devices are thermometers and stethoscopes.
• Invasive: Invasive devices pierce or enter the body through an opening or its surface. Due to the deeper interaction with the body, invasive devices carry higher risks and typically fall under Class IIb or Class III medical devices. Examples of invasive medical devices are catheters and implants.
• Active: Active devices rely on an external power source like electricity, batteries, or chemicals to function. The active nature and potential impact on bodily systems necessitate increased regulatory oversight, often placing them in Class IIb or Class III medical devices. Examples of active medical devices are pacemakers and insulin pumps.

Furthermore, the duration of use is also considered when classifying medical devices, as follows.

• Transient: Transient devices are intended for continuous use for less than 60 minutes.
• Short-term: Short-term use devices are intended for continuous use between 60 minutes and 30 days.
• Long-term: Long-term use devices are intended for continuous use for more than 30 days.

Understanding the classification of a medical device is essential as it dictates the regulatory requirements medical devices need to comply with. Determining the correct class also ensures patient safety and avoids compliance issues.

What Is an EU MDR Class I Medical Device?

Class I medical devices under the EU MDR are considered low-risk devices. Class I medical devices are usually non-invasive and for transient use. Consequently, due to the low-risk profile, Class I medical devices have less stringent regulatory requirements compared to higher-risk devices.

Class I medical devices are subdivided based on device-specific features.

Class I medical devices can be placed on the market in sterile condition (Class Is), with a measuring function (Class Im), or reusable (Class Ir), as explained below.

• Class Is: Class Is indicates a sterile device, for example, a personal protection kit.
• Class Im: Class Im indicates the medical device has a measuring feature, for instance, thermometers.
• Class Ir: Class Ir comprehends a reusable device, for example, surgical instruments.

The certificated Class I medical devices comprised 12% of all medical devices, according to the European Database on Medical Devices (EUDAMED), in 2023.

What Are EU MDR Class I Medical Device Examples?

Examples of medical devices in Class I are given below.

• Surgical instruments
• Manual stethoscope
• Sterile urine bags
• Corrective glasses and frames
• Manual wheelchairs
• Plasters
• Thermometers
• Bedpans
• Hospital beds
• Personal protection kits
• Weighing scale
• Endoscopes

What Is EU MDR Class IIa Medical Device?

Class IIa medical devices present moderate risk under EU MDR, posing a higher potential for harm than Class I medical devices but lower than Class IIb and Class III medical devices.

Class IIa medical devices are usually surgically invasive devices intended for transient and short-term use. Active medical devices intended for diagnosis and monitoring are also classified as Class IIa.

Of all approved medical devices on the market, 44% are considered Class IIa, according to the EUDAMED in 2023.

What Are EU MDR Class IIa Medical Device Examples?

Examples of medical devices in Class IIa are given below.

• Surgical clamps
• Diagnostic software
• Hearing aids
• Catheters
• Infusion pumps
• Ultrasonic diagnostic equipment

What Is EU MDR Class IIb Medical Device?

Class IIb medical devices represent a significant medium risk, bridging the gap between moderate-risk Class IIa and high-risk Class III medical devices.

Class IIb medical devices are usually implantable and long-term surgically invasive devices with a greater impact on patient health than lower classes.

Of all the certified medical devices, 33% are considered Class IIb, according to the EUDAMED in 2023.

What Are EU MDR Class IIb Medical Device Examples?

Examples of medical devices in Class II are given below.

• Blood bags
• Intensive care monitoring equipment
• Ventilators
• Implantable dental devices
• Long-term corrective contact lenses
• Short-term implantable catheters
• Surgical lasers
• High-intensity focused ultrasound equipment

What Is EU MDR Class III Medical Device?

Class III medical devices under the EU MDR represent the highest risk category. Class III medical devices encompass active implantable medical devices and long-term surgically invasive medical devices that directly or indirectly support life.

The high-risk nature of Class III medical devices requires strict regulations to ensure patient safety and device effectiveness.

Certificated Class III medical devices comprised 11%, according to the EUDAMED, in 2023.

What Are EU MDR Class III Medical Device Examples?

Examples of medical devices in Class III are given below.

• Defibrillators
• Prosthetic heart valves
• Implanted prosthetics
• Cardiovascular catheters
• Automated external defibrillators
• Aneurysm clips

How To Classify Your Medical Device According to EU MDR Classification Rules?

The EU MDR outlines the classification rules for medical devices in Chapter III of Annex VIII, which details the criteria for assigning devices to their appropriate risk class.

The EU MDR utilizes 22 classification rules grouped into four distinct categories, as listed below.

• Non-invasive devices
• Invasive devices
• Active devices
• Special rules

Non-invasive Devices

Non-invasive medical device classification comprehends rules 1 to 4.

Non-invasive device rules cover devices that do not penetrate the body’s natural surface and are considered low-risk due to minimal interaction with the body. The rules assess the device’s intended use, materials, and duration of use.

Medical devices covered by rules 1 to 4 are generally considered Class I medical devices. However, Class IIa, Class IIb, and Class III medical devices can also be used for non-invasive devices.

Invasive Devices

Invasive medical device classification encompasses rules 5 to 8.

Invasive device rules apply to devices breaching the body’s surface, which pose a more significant risk than non-invasive ones. The rules consider invasiveness level, intended use, and potential for infection or tissue damage.

Medical devices under rules 5 to 8 are mostly considered Class IIa, Class IIb, and Class III medical devices. Still, some devices categorized under these rules are classified as Class I.

Active Devices

Active medical device classification comprises rules 9 to 13.

Active device rules concern medical devices relying on external power to operate, such as pacemakers and insulin pumps. The rules highlight energy source hazards, software safety, and the potential for malfunction.

Medical devices comprised in rules 9 to 13 can pertain to Class I, Class IIa, Class IIb, and Class III, depending on body placement and duration of use. For example, medical devices intended to illuminate the patient’s body in the visible spectrum are classified as Class I, while software designed to monitor physiological processes is classified as Class IIa.

Special Rules

Special rules for medical device classification are the rules 14 to 22.

Special rules address unique situations not easily categorized in the previous groups. These rules cover devices incorporating medicinal products, devices manufactured utilizing tissues or cells, and devices for contraception or prevention of the transmission of sexually transmitted diseases, among other special cases.

The special rules focus on specific risk factors and potential complications associated with devices’ unique features.

Medical devices covered by rules 14 to 22 can be classified as Class IIa, Class IIb, or Class III.

What Is the Difference Between EU MDR and FDA Medical Device Classification?

The EU MDR takes a more detailed approach to medical device classification than the FDA. The FDA focuses on the overall risk of the device without delving into finer details like body placement and duration of use.

According to the FDA medical device classification, medical devices are divided into three categories with increasing harm potential: Class I, Class II, and Class III.

What Are the Different EU MDR Medical Device Regulatory Approval Pathways?

The EU MDR medical device approval pathway is directly linked to the device classification, with stricter controls for higher-risk medical devices.

Class I medical devices, posing the least risk, face fewer regulatory requirements. Manufacturers of Class I medical devices can self-declare compliance with common specifications. On the contrary, Class III medical devices, carrying the highest risk, face the most rigorous requirements, including submitting a comprehensive clinical evaluation.

All medical devices intended for sale or marketing in the EU must bear the CE marking, except those medical devices that are used exclusively for research. The CE marking proves product compliance with the EU MDR.

The regulatory pathway for each device class includes the following.

• Class I: Common Specifications, post-market surveillance (PMS), EU declaration of conformity, and CE marking.
• Class IIa: Common Specifications, PMS, Periodic Safety Update Report (PSUR), EU declaration of conformity, and CE marking.
• Class IIb: Common Specifications, PMS, PSUR, clinical evaluation consultation, EU declaration of conformity, and CE marking.
• Class III: Common Specifications, PMS, PSUR, clinical evaluation consultation, EU declaration of conformity, and CE marking.

Below is a visual overview of the different EU MDR medical device regulatory approval pathways.

EU MDR Class I Medical Device Approval Pathway

The pathway to market for Class I medical devices encompasses compliance with the Common Specifications, post-market surveillance (PMS), EU declaration of conformity, and CE marking.

Common specifications are basic requirements all classes of medical devices must comply with. The common specifications include the following requirements.

• General safety and performance requirements that are set out in MDR Annex I.
• Technical documentation requirements are set out in MDR Annexes II and III.
• Clinical evaluation and post-market clinical follow-up (PMCF) are set out in MDR Annex XIV.
• Clinical investigation requirements are set out in MDR Annex XV.

Class I medical device manufacturers must implement a post-market surveillance (PMS) system. The PMS system must be suited to gather, record, and analyze relevant data on the device’s quality, performance, and safety throughout its lifecycle. From this data, manufacturers identify issues and implement any necessary corrective and preventive actions.

The EU declaration of conformity demonstrates compliance with the requirements. For Class I medical devices, the declaration of conformity can be self-declared without needing an assessment by a notified body.

After Class I medical devices are approved by national authorities, manufacturers can place the CE marking on the medical device and access the EU market.

EU MDR Class IIa Medical Device Approval Pathway

The pathway for Class IIa medical devices within the EU MDR comprehends the Common Specifications, PMS, Periodic Safety Update Report (PSUR), EU declaration of conformity, and CE marking.

Class IIa medical devices are subject to the same common specifications and PMS requirements as Class I medical devices.

However, a notified body must assess compliance with applicable requirements due to Class IIa devices’ higher potential risk of harm. For Class IIa medical devices, the notified body is responsible for issuing the EU declaration of conformity.

Class IIa medical devices are required to provide the Periodic Safety Update Report (PSUR). The PSUR summarizes the results and conclusions of the analyses of the post-market surveillance data gathered. The PSUR must include a rationale and description of any preventive and corrective actions taken in case of issues.

Upon approval of both national authorities and a notified body, Class IIa medical devices can receive the CE marking and access the EU market.

EU MDR Class IIb Medical Device Approval Pathway

The pathway to market for Class IIb medical devices includes compliance with the Common Specifications, PMS, PSUR, clinical evaluation consultation, EU declaration of conformity, and CE marking.

Class IIb medical devices follow the same regulatory pathway as Class IIa medical devices.

On the other hand, Class IIb medical devices pose a moderately higher risk to patients. Thus, the notified body must perform a clinical evaluation consultation during the conformity assessment.

The clinical evaluation consultation analyzes the Class IIb medical device’s clinical data, particularly the device’s benefit-risk profile and compatibility with the intended use.

EU MDR Class III Medical Device Approval Pathway

The regulatory pathway for Class III medical devices faces the most rigorous requirements, including Common Specifications, PMS, PSUR, clinical evaluation consultation, EU declaration of conformity, and CE marking.

Class III medical devices under EU MDR are subject to all requirements applicable to Class I, Class IIa, and Class IIb medical devices, from general safety requirements to clinical evaluation consultations.

After Class III medical devices receive approval from national authorities and notified bodies, manufacturers can affix the CE marking on the device and access the EU market.

What Is the Role of eQMS in Facilitating EU MDR CE Marking Regulatory Process?

Electronic Quality Management System (eQMS) facilitates obtaining CE marking for medical devices under the EU MDR by streamlining quality-related processes, workflows, and documentation required for compliance.

Electronic QMS simplifies the creation, version control, and storage of vital documentation, including technical files, post-market surveillance reports, and clinical evaluations. The eQMS improves accessibility and traceability, facilitating efficient reviews by authorities and notified bodies.

The medical device QMS software supports compliance with several regulatory requirements, including ISO 13485:2016, MDR, IVDR, GMP, 21 CFR Part 11, and 820, among others.

SimplerQMS offers a fully GAMP 5-validated QMS software solution, supporting compliance with EU MDR for medical device quality management systems.

The SimplerQMS solution helps medical device companies comply with regulatory requirements with comprehensive QMS process support. SimplerQMS supports several QMS processes, such as document control, change management, training, risk management, audit management, CAPA management, and more.

Streamline your EU MDR approval process with SimplerQMS. Schedule a personalized demo with one of our Quality Solution Consultants today to discover how the SimplerQMS solution can enhance your quality management processes and accelerate your time to market.