Here in the United States, what qualifies and can operate as a “medical device” is wide-ranging and complicated. Pathway NPI put together a quick but comprehensive classification guide for medical devices to help illustrate the step-by-step process taken to get these products to market.
Classification Pathways for Medical Devices
Many of the complications in the classification process are due to the fact that medical devices are regulated by multiple government agencies. In addition, there are three different pathways medical device manufacturers can take in order to get their products legally marketed and sold in the United States.
The three marketing authorization pathways for medical devices are:
- Premarket Notification (510(k))
Premarket Notification (510(k)) is the most common pathway. In order to take this route, medical device manufacturers must prove that their device is “substantially equivalent” to a medical device that is already on the market.
- De Novo classification
De Novo classification is for new medical devices that have no predicate device to reference. In order to take this route, manufacturers must provide sufficient data to prove that the medical device is safe and effective for its intended use.
- Premarket Approval (PMA)
Premarket Approval (PMA) is the strictest of the three pathways and is required for medical devices that are considered high-risk. In order to take this route, manufacturers must provide extensive data proving that their medical device is safe and effective for its intended use.
Regardless of which pathway a medical device manufacturer chooses, all medical devices must go through a classification process in order to be legally marketed and sold in the United States.
Determining which pathway to follow depends on the regulatory classification of your device. In order to decide which classification your medical device falls into, you first need to determine if it is considered a “device” or a “component” under FDA law.
Classifications for Medical Devices Around the World
Here in the U.S., classification for medical devices is determined and governed by the U.S. Food and Drug Administration (FDA). They fall into three regulatory classes:
- Class I medical devices present the lowest risk to patients and are therefore subject to the least regulatory controls.
- Class II medical devices present a moderate risk to patients and are subject to more controls than Class I medical devices.
- Class III medical devices present the highest risk to patients and are subject to the most controls.
Classification in other countries around the world is generally similar, but may vary slightly due to different governing bodies.
European Medical Device Regulation
In Europe classification is determined by the European Commission (EC), and medical devices are placed into one of four classes:
- Class I medical devices present the lowest risk and are subject to the least regulatory controls.
- Class IIa medical devices present a moderate risk and are subject to more controls than Class I medical devices.
- Class IIb medical devices present a higher risk and are subject to more controls than Class IIa medical devices.
- Class III medical devices present the highest risk and are subject to the most controls.
[Canadian Medical Device Regulation
And in Canada, medical devices are classified by Health Canada and placed into one of three classes:
- Class I medical devices present the lowest risk to patients and are subject to the least regulatory controls.
- Class II medical devices present a moderate risk to patients and are subject to more controls than Class I medical devices.
- Class III medical devices present the highest risk to patients and are subject to the most controls.
As you can see, while there are some similarities between the classification systems used in different countries, there are also some important differences that medical device manufacturers need to be aware of.
Medical Device Subclasses
It’s also worth noting that medical devices may be further subclassed within each class, depending on the specific risks they pose. For example, in the U.S., Class III medical devices are subdivided into three subclasses:
- Implantable medical devices
- Life-supporting medical devices
- Life-sustaining medical devices
Similarly, in Europe, Class III medical devices are also subdivided into three subclasses:
- Active implantable medical devices
- In vitro diagnostic medical devices
- Custom-made medical devices
Now, you understand the different pathways that are available for each class of medical device in the United States, and how categorization for medical devices is determined.
Medical Device Examples
Let’s review some of the medical devices classified as Class I, Class II, and Class III here in the U.S. to give you an idea of the differentiation involved.
Class I examples:
- Elastic bandages
- Hearing aids
- Infusion pumps
Class II examples:
- Blood pressure cuffs
- Glucose meters
- Nebulizers
Class III examples:
- Cardiac pacemakers
- Implantable defibrillators
- Implanted hearing aids
The risk posed to patients increases as you move from Class I medical devices to Class III medical devices. Hence the need for classification tiers (which are further separated into subclasses in some cases).
How To Classify Your Medical Device and Get It Approved
Now that you understand the basics of medical device classification, we’ll go over the process of how to get your medical device classified and approved for market. The first step is to choose the right regulatory pathway.
If you’re looking to bring a Class I medical device to market in the U.S., you can do so via the 510(k) premarket notification pathway or through the de novo classification process.
Class II medical devices can also be brought to market via the 510(k) premarket notification pathway, but may require a PMA (premarket approval) if they don’t have a predicate device on the market.
Finally, Class III medical devices will always require a PMA (premarket approval).
The second step is to submit the appropriate paperwork to the FDA. And the third and final step is to receive FDA approval, and then bring your medical device to market.
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Explore information on ISO standards for medical devices and more on our website. We look forward to assisting with your medical device development at any stage.
The International Organization for Standardization, or ISO, is a globally recognized group of representatives. Headquartered in Geneva, Switzerland, they develop and publish standards for dozens of industries. This includes the medical and medical device ISO standards put into practice daily here at Pathway NPI. Both ISO 9001 and 13485 are quality management system standards that can be used by organizations to ensure that their products and services meet customer expectations. However, there are some key differences between the two standards.
We’ll take you through the history behind the ISO, how these quality standards originated, and how they can best be applied today. These standards apply to our daily work in design and engineering, regulatory, and manufacturing.
The History of ISO Standards
ISO standards originated in the 1940s in an effort to standardize technical drawings across different industries. In response to the devastation of World War II, representatives from 25 countries gathered together to form what is now known as the ISO.
During the 1950s, ISO focused on creating standards for mechanical engineering. In the following decade, they shifted their attention to standardizing electronic components. It was during this time that some of the most well-known standards were published, including ISO 27001 and ISO 9001.
In 1987, ISO released the first iteration of ISO 13485. This was a quality management system standard specifically for medical device manufacturers. Since then, there have been several updates to both iso 9001 and iso 13485, with the most recent versions in place today.
While ISO 9001 is a generic quality management system standard that can be applied to businesses in any industry, ISO 13485 is specific to the medical device industry.
Organizations that want to demonstrate compliance with ISO 9001 can do so by implementing a quality management system and being audited by a third-party certification body. On the other hand, ISO 13485 compliance requires a quality management system specific to the medical device industry as well as third-party audits.
Get to Know ISO 9000
The ISO 9000 family of standards is all about quality management. In fact, it is the best-known quality management standard currently in place for businesses of all sizes.
The ISO 9000 family of standards is related to quality management systems and provides guidance on how to meet customer expectations. The most recent version, ISO 9001:2015, was published in September 2015. It outlines the requirements for a quality management system and can be used by any organization, regardless of size or industry.
ISO 9000 standards originated in 1987 and were created to help businesses improve their quality management systems. The family of standards includes ISO 9000, ISO 9001, and ISO 9004.
ISO 9000 is a generic standard that provides guidance on how to establish and operate a quality management system. It’s the foundation of the ISO 9001 standard and can be used by any organization, regardless of size or industry.
ISO 9001
ISO 9001 is a generic standard that can be used by any organization, regardless of its size or type of business. Any organization that wants to certify to ISO 9001 must follow the requirements in this standard.
In order to become certified to ISO 9001, an organization must go through a certification process conducted by an external body. This usually includes an audit of the organization’s quality management system to ensure that it meets all of the requirements laid out in the standard. Once certified, the organization will need to undergo periodic surveillance audits to maintain their certification status.
ISO 9004 is a guideline for organizations that want to exceed ISO 9001 requirements and continually improve their performance.
How to Demonstrate Compliance with ISO 9001
In order to demonstrate compliance with ISO 9001, organizations must implement a quality management system and be audited by a certification body. The certification process usually includes an assessment of the organization’s quality management system to ensure that it meets all of the requirements laid out in the standard. Once certified, the organization will need to undergo periodic surveillance audits to maintain their certification status.
Organizations that are already certified to ISO 9001 can transition to the 2015 version of the standard by following the guidance laid out in Annex SL of ISO 9001:2015.
Annex SL is a new framework for all ISO management system standards that provides a high-level structure and common terminology. This makes it easier for organizations to implement multiple ISO standards as well.
3 key takeaways:
– ISO 9001 is a quality management system standard that can be used by any organization, regardless of size or industry.
– Organizations can demonstrate compliance with ISO 9001 by implementing a quality management system and being audited by a certification body.
– The Annex SL framework provides a high-level structure and common terminology for all ISO management system standards. This makes it easier for organizations to implement multiple ISO standards.
Get to Know ISO 13485
ISO 13485, on the other hand, is specific to organizations that design and manufacture medical devices. It was first created in 1996 and has been updated several times since then, with the most recent version being published in 2016.
ISO 13485 is based on the ISO 9001 quality management system requirements and provides additional guidance specifically for the medical device industry.
In order to become certified to ISO 13485, organizations must implement a quality management system that meets all of the requirements laid out in the standard. They must also be audited by a certification body to ensure compliance. Once certified, they will need to undergo periodic surveillance audits to maintain their certification status.
How to Demonstrate Compliance with 13485
Compliance with ISO 13485 can be demonstrated by implementing a quality management system that meets all of the requirements laid out in the standard. Organizations must also be audited by a certification body to ensure compliance. Once certified, they will need to undergo periodic surveillance audits to maintain their certification status.
Key takeaways:
– ISO 13485 is a quality management system standard specifically for organizations that design and manufacture medical devices.
– Compliance with ISO 13485 can be demonstrated by implementing a quality management system and being audited by a certification body.
– The requirements of ISO 13485 are based on those of ISO 9001, with additional guidance specifically for the medical device industry.
Help With ISO Standard Compliance
In order to demonstrate compliance with either ISO 9001 or 13485, organizations must implement a quality management system. This system should be designed to meet the specific needs of the organization and its customers.
The quality management system must be regularly audited by a certification body to ensure compliance with the relevant standard. Once certified, the organization will need to undergo periodic surveillance audits to maintain their certification status.
The ISO standards for medical devices are significant — and can appear overwhelming. Here at Pathway NPI, a storied medical device company in San Diego, we have had great success at guiding companies through the steps as they develop their own products. We can help you too. If you have questions about 510(k) clearance vs. approval, we can answer those questions as well!
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