Medical Device Classification Guide

by | Nov 5, 2021 | Medical Devices

If you are a manufacturer of medical devices and plan to market your product in either the US or EU markets, you must classify your medical device according to the edicts of the respective regulatory agency.

The purpose of classifying your medical device is to determine the applications and type of premarket submissions that are required.

In this article, we will look at the differences between the FDA medical device classes, and EU MDR medical device classes. We will also discuss different approaches for determining how your medical device will be classified by the US FDA and European Commission and get a basic understanding of regulatory product classification.

In this guide, you’ll learn:

NOTE
This post is not a comprehensive guide to medical device classification but a simplified, introductory guide to the classification of medical devices in the US and the EU. Always follow the standards applicable to you and your company!

What Is Medical Device Classification?

The classification of medical devices is to determine the level of harm they can pose to the end-users, namely patients. In general, Class I includes all medical devices that have the lowest risk and Class III has those medical devices with the highest risk.

For instance, your medical devices company is dealing with handheld surgical instruments, deep-brain stimulators, and computed tomography (CT) scanners, amongst others. When you market these in the US market, you will realize that you need to classify handheld surgical instruments as Class I, deep-brain stimulators as Class III, and CT scanners as Class II.

Why Medical Device Classification Is Important?

Classifying the medical devices produced by your company is important for the following reasons:

  • Classification will help you determine what must be done before selling your product.
  • Classifying your medical devices will help you in establishing requirements during the development phase of the product, primarily design controls.
  • A crucial point for medical device companies is the costs involved and the timeframe for launching their product in a given market. With product classification, you will get an estimate of the overall costs and time required to bring a medical device to the market.

Classification Strategy: Where to Get Approved First?

As a medical device manufacturer, you need to decide whether to seek US FDA approval or EU Medical Device Regulation (MDR) first. Resource constraints may not permit a simultaneous approval process.

Before May 26, 2021, the European Union’s Conformité Européenne (CE) mark was easier to obtain compared to the US FDA approval for medical devices. Since the CE mark had limitations, even within some of the EU nations, it was considered less influential.

The new EU MDR guidelines are significantly closer to FDA requirements concerning the following:

  • Preconditions for conformity assessment
  • QMS compliance

Let us take a look at key differences between these two regulatory approvals – classification of devices and risk process.

The US FDA’s classification of a medical device is based on its risk. Low and moderate-risk devices are classified as either Class I or Class II medical devices. These are regulated by the 510(K) regulation. You must demonstrate that your device has a similar function to a previously approved device. Class III devices are high-risk devices that need far more validations.

The EU MDR has 4 categories of devices:

  • Non-invasive medical devices
  • Invasive medical devices
  • Active medical devices
  • Special category

The medical devices are also classified based on risk, which will give a measure of the data and the type of evaluation required by the manufacturer. Based on risk management, medical devices are grouped in one of the following five different risk-based classes:

  • Class I (Basic): Non-sterile or no measuring function (i.e. low risk)
  • Class I (Special Function): Sterile and a measuring function (i.e. low to medium risk)
  • Class IIa: Medium risk
  • Class IIb: Medium to high risk
  • Class III: High-risk Risk process

According to the US FDA requirements, Class II devices onwards need to be audited with various evaluations. Under EU MDR, auditing requires wide-ranging technical documentation and risk evaluation. This documentation can efficiently be managed in an Electronic Quality Management System (eQMS).

A cursory glance at the details given will indicate that it is easier to get approval for your medical device first in the USA.

FDA Medical Device Classification

If you wish to market your medical devices in the US market, you need to know that medical devices are classified as Class I, Class II, or Class III. This classification is based on the risk your medical device has for the end-user, namely patients.

This classification is tied to the intended use and indication for use of the medical device.

The definitions are as follows:

  • Intended use: This term describes your claim what the medical device does. It means the general purpose/function of the medical device.
  • Indications of use: This term describes what disease your medical device is to diagnose, prevent, cure, treat, or alleviate. It also includes the target population of patients.

FDA Class I Medical Devices

Class I medical devices are defined by the FDA as follows:

“not intended for use in supporting or sustaining life or of substantial importance in preventing impairment to human health, and they may not present a potential unreasonable risk of illness or injury.”

Class I medical devices have a low to moderate risk for the patient.

Around 47 percent of all medical devices are in this category and 95 percent of these are exempt from the regulatory process.

You should note that Class I medical devices have minimal contact with the patient. They do not come in contact with the patient’s cardiovascular system, the central nervous system, or internal organs.

When a device is in a generic category of exempted class I medical devices, there is no requirement for a premarket notification application or FDA clearance before marketing the device in the US market. However, you are required to register your company and list the generic devices with the FDA.

Examples of Class I medical devices:

  • Plasters
  • Electric toothbrushes
  • Enema kits
  • Bedpans
  • Manual stethoscopes
  • Tongue depressor
  • Oxygen mask
  • Hospital beds

The Path to Market for Class I Medical Devices in the US

When marketing Class I medical devices in the US, you must note the following.

Class I medical devices are the quickest to bring to the US market because they present the lowest risk to the patient.

The majority of Class I medical devices are exempt from the FDA’s requirements for Premarket Approval (PMA) and Premarket Notification (PMN) or 510(k).

Class I medical devices are subject to the FDA’s general controls. These are a series of controls that apply to all medical devices (i.e., Class I, II, and III). They address device registration, adulteration, misbranding, record maintenance, and good manufacturing practices.

FDA Class II Medical Devices

Class II medical devices are defined by the FDA as follows:

“devices for which general controls are insufficient to provide reasonable assurance of the safety and effectiveness of the device.”

Class II medical devices have a moderate to high risk for the patient. They present a greater risk to the patient because of sustained contact. These medical devices usually come in contact with the patient’s internal organs or cardiovascular system, and various diagnostic tools. Around 43 percent of all medical devices are in this category.

Examples of Class II medical devices:

  • Powered wheelchairs
  • Pregnancy test kits
  • Catheters
  • Blood pressure cuffs
  • Blood transfusion kits
  • Surgical gloves
  • Absorbable sutures
  • Syringes
  • Contact lenses

The Path to Market for Class II Medical Devices in the US

When marketing Class II medical devices in the US, you must note the following.

Premarket Notification (PMN) or 510(k) process: You need to demonstrate that your Class II medical device is safe and effective. How do you do this?

By showing ‘substantial equivalence’ with another device (called ‘predicate’ device) that is already in the market. The devices need not be identical. But, there must be substantial similarities in design, materials, use, labeling, standards, etc.

To efficiently manage your PMN or 510(k) submissions, you can consider using QMS software for medical devices.

Exemption to the 510K filing: Over 800 generic Class I and Class II medical devices have been exempted from the 510K submission process. The list can be accessed in the FDA Product Classification Database.

General controls: As mentioned above, Class II medical devices are also subject to general controls. However, the FDA adds that these are devices for which general controls are insufficient to give reasonable assurance of safety and effectiveness. It is for this reason that Class II medical devices are further subject to special controls.

Special controls: Patient registries, premarket data requirements, post-market surveillance, special labeling requirements.

FDA Class III Medical Devices

Class III medical devices are defined by the FDA as follows:

“usually sustain or support life, are implanted or present a potential unreasonable risk of illness or injury.”

Class III medical devices have the highest risk for the patient. They are usually used to sustain or support life, are implanted, and present a potential risk of injury or illness. Around 10 percent of all medical devices belong to this category.

Examples of Class III medical devices:

  • Breast implants
  • Implantable pacemakers
  • Cochlear implants
  • Defibrillators
  • High-frequency ventilators
  • Fetal blood sampling monitors
  • Implanted prosthetics

The Path to Market for Class III Medical Devices in the US

When marketing Class III medical devices in the US, you must note the following.

Due to the level of risk associated with Class III medical devices, the FDA has regulated that general and special controls (applicable to Class I and II medical devices) are not sufficient to ensure the safety and efficacy of these devices.

Premarket Approval (PMA): You need to do a rigorous study of your medical device using a data-driven benefit/risk profile to prove its safety and effectiveness. This will require clinical trial data and considerable time and resources.

Exceptions to the PMA clause are Class III medical devices with a substantial equivalent. You may check whether the Class III medical device can be marketed using the 510(k) process by checking both the FDA Premarket Approval (PMA) database and the FDA 510(k) Premarket Notification Database.

The summary of FDA medical device classification is illustrated below.

US FDA Medical Device Classification Infographic

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How to Determine Your Medical Device Class in the US

There are different ways by which medical device manufacturers can determine the class of their medical devices in the US market.

Firstly, you can check the FDA Medical Device Classification Panels, which is a list of categories for medical devices according to their medical specialization.

Medical Device Classification Panels

Let us look at a Microbiology Anaerobic Chamber as an example.

This device is classified under medical specialty 83: Microbiology.

Medical Device Classification Panels

The next step after locating the relevant medical specialty is to click on the Regulation Citation (21 CFR) and then navigate the list of devices until you have located an equivalent device and the associated device code.

21 CFR Part 866 Microbiology

Once you have clicked on the device code (in this case – § 866.2120 – Anaerobic chamber), you will get the guidelines.

21 CFR Part 866 Microbiology Anaerobic Chamber

Under section (b), the classification of the device is mentioned.

Other ways to determine your medical device class in the US are the following:

  1. You can use a free, confidential, and informal device determination service via email: DeviceDetermination@fda.hhs.gov
  2. You can submit an F13(g) request, this is formal and binding, and requires a fee.
  3. Hire a medical device consultant who has thorough knowledge about the entire process.

EU Medical Device Classification

If you wish to market your medical device in the European market, you must obtain a CE marking, even if you are importing the product from outside the Economic European Area (EEA). With the CE mark, you ensure that your medical device complies with all essential requirements that are stipulated by the European Union’s Medical Device Regulation (EU MDR 2017/745).

For this, first, you will need to decide what EU classification your medical device comes under.

All the required information is provided by the European Union’s Medical Device Regulation (EU MDR 2017/745) that was implemented in May 2021. However, for some Class I medical devices, compliance has been deferred until 2024.

First-of-all, you will need to decide whether your medical device is non-invasive/invasive/active:

  • Non-invasive: The medical device should not penetrate the body through the body’s surface or via an orifice. Such devices are characteristically Class I. Some certain exceptions and rules can make these Class I medical devices Class II or higher.
  • Invasive: Any medical device, either in part or whole, penetrates the surface of the body or via an orifice.
  • Active: A medical device whose functioning depends on a source of energy other than the energy generated by the human body, or by gravity. When such a device is operated, density is changed or such energy is converted.

Rules 1-4 of Annex VIII are for non-invasive devices; rules 5-8 are for invasive devices and rules 9-13 are for active devices.

You should be aware that for the above-mentioned categories, specific rules apply. These are highlighted in Annex VIII of the new MDR (refer to Article 2 ‘Definitions’).

Classification of your medical device is upfront based on the broad categories combined with the duration of use:

  • If the medical device is continuously used for less than 60 minutes, it is considered transient duration.
  • If the medical device is used for a duration between 60 minutes to 30 days, it is considered short-term.
  • If the medical device is used for over 30 days, it is considered long-term.

The product classification system followed in the EU is similar to that of the US.

There are 4 different classes, namely:

  • Class I
  • Class IIa
  • Class IIb
  • Class III

For all medical devices that will be sold in the EU, a required step for obtaining CE marking is medical device technical documentation. You will also need to work with a Notified Body, except in the case of Class I medical devices.

Additionally, you will need to work with an Authorized Representative who will ensure your product registration.

EU Class I Medical Devices

These medical devices have the lowest observed risk and they make up about 70 percent of the market.

Class I has several subclasses.

Basic Class I: These devices are non-sterile and have no measuring function, for example:

  • Bedpans
  • Hospital beds
  • Plasters
  • Manual Wheelchairs
  • Corrective glasses and frames

Class Is: These devices are placed in the market in a sterile condition, for example:

  • Personal protection kits
  • Sterile urine bags

Class Im: These devices have a measuring function, for example:

  • Weighing scale
  • Thermometers
  • Stethoscope

Class Ir: This is a new subclass for medical devices that are reprocessed or reused, for example:

  • Endoscopes
  • Surgical instruments

The Path to Market for Class I Medical Devices in the EU

When marketing Class I medical devices in the EU, note the following.

Basic Class I devices do not need certification from a Notified Body. All you need to do is self-certify it, and formally declare its compliance via a written statement.

For Class Is, Im, and Ir medical devices: You need a Notified Body assessment.

EU Class IIa Medical Devices

These medical devices exchange energy with the patient in a therapeutic manner. They are used to monitor or diagnose medical conditions.

They make up around 20 percent of the market. These devices are generally invasive but limited to the natural orifices of the body.

Class IIa medical devices usually constitute low to medium risk. Patients use them for a short-term period, namely, usually 60 minutes to less than 30 days.

Some examples are:

  • Catheters
  • Hearing aids
  • Ultrasonic diagnostic equipment
  • Surgical clamps

The Path to Market for Class IIa Medical Devices in the EU

When marketing Class IIa medical devices in the EU, note that you will need to:

  • Prepare a Technical File or Design Dossier and demonstrate conformity with applicable requirements
  • Contact an Authorized Regulatory Representative who is based in the European Community
  • Complete a Notified Body Audit of a QMS and Technical File or Design Dossier
  • Secure the CE mark and obtain a Unique Identifier (UDI) after having registered the manufacturer and device in the EUDAMED database

To secure a CE mark, you might consider using medical device QMS software for managing your submission documentation in an efficient and compliant way.

EU Class IIb Medical Devices

These are medium to high-risk medical devices that patients may use for longer than 30 days. They make up around 8 percent of the market.

Some examples of such devices are:

  • Long-term corrective contact lenses
  • Surgical lasers
  • Defibrillators

The Path to Market for Class IIb Medical Devices in the EU

Note that the level of control for Class IIb medical devices is similar to that of Class III medical devices. There is no separate CE certificate issued for assessing the technical documentation. Also, the expert panel participation in the review process is not required, except when the Class IIb medical device is active and the intended use is to administer or remove a medicinal substance.

When marketing Class IIb medical devices in the EU, note that you will need to:

  • Prepare a Technical File or Design Dossier and demonstrate conformity with applicable requirements
  • Contact an Authorized Regulatory Representative who is based in the European Community
  • Complete a Notified Body Audit of a QMS and Technical File or Design Dossier
  • Secure the CE mark and obtain a Unique Identifier (UDI) after having registered the manufacturer and device in the EUDAMED database

EU Class III Medical Devices

These medical devices have the highest possible risk for the patient. Permanent monitoring is essential during the lifetime of these products.

To ensure the safety and effectiveness of these devices, pre-market approval is required.

Such medical devices make up around 1.8 percent of the market.

Examples are:

  • Cardiovascular catheters
  • Hip-joint implants
  • Prosthetic heart valves
  • Aneurysm clips

The Path to Market for Class III Medical Devices in the EU

A viable option for marketing Class III medical devices in the EU is Annexe IX, which included a full QA audit and a full Technical Documentation review. Additionally, Class III devices are assessed by an expert panel.

When marketing Class III medical devices in the EU, note that you will need to:

  • Prepare a Technical File or Design Dossier and demonstrate conformity with applicable requirements
  • Contact an Authorized Regulatory Representative who is based in the European Community
  • Complete a Notified Body Audit of a QMS
  • Complete Design Dossier review by a Notified Body
  • Secure the CE mark and obtain a Unique Identifier (UDI) after having registered the manufacturer and device in the EUDAMED database

The summary of EU MDR medical device classification is illustrated below.

EU MDR Medical Device Classification Infographic

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How to Determine Your Medical Device Class in the EU

As a medical device manufacturer planning to enter the EU market, you will first need to broadly categorize your device into:

  • Non-invasive
  • Invasive
  • Active

Next, you will look at all the applicable rules and pick the one with the highest risk, just to be sure, and identify the main intended use of your device.

Let us take the example of infusion cannulae. It fits into the ‘invasive’ category. Thus, the research is narrowed down to Rules 5,6,7, and 8.

Further, you will see that it is for short-term use (between 60 minutes and 30 days).

Thus, Rule 7 becomes applicable for classifying this device.

Final Thoughts

If you are a manufacturer of medical devices and plan to market your products in the US and EU markets, you need to classify these medical devices. You must follow the regulatory requirements in your market as it will also help you market your product quicker.

A crucial aspect of quality management for your company in general, and your medical devices, is to meet compliance.

SimplerQMS can help you manage product design controls, change control activities, and other quality events. It allows you to interlink documents and store everything in a central system, providing you with cross-functional visibility throughout the lifecycle of your medical device.

SimplerQMS solution is specifically designed for the Life Science industries, such as the Medical Device industry, and aligned with the relevant regulations and standards.

We recommend you schedule a demo to see SimplerQMS in action and talk to our experts to see how we can help you work more efficiently with your documentation.

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