Medical Device Classification
Around the world, the various medical device regulatory bodies classify medical devices according to their perceived risk and use this classification to determine which regulatory requirement apply to the device.
What is Medical Device Classification?
Medical devices are classified according to their perceived risk and this classification determines which regulatory requirements apply to the device. Regulatory bodies around the world apply the same principle of medical device classification, but the exact details of the classification schemes in different countries vary slightly.
The classification of medical devices is based on an evaluation of potential risks that using the medical device may pose to human health. The level of classification is, as a general rule, related to the perceived risk of the product type. Various criteria control the classification rules around the world.
Device classification is important because it:
determines what you have to do before you can sell the device.
helps you establish design control requirements during the development phase.
helps determine the cost and time required to get your device to market.
3 Things to consider when classifying your Medical Device
⇒ Always check the regulations for your target market to confirm that you are classifying your medical device correctly.
⇒ Determine the classification of your medical device as early as possible in the development life-cycle to minimise the number of problems during certification.
⇒ Avoid over-classifying your device. While it may feel like you are producing a “safer” device, there is a significant overhead in terms of things like documentation and testing that will be required.
How many classes of medical device are there?
The number of classes of medical devices depends on the target market. Some examples are:
There are four classes in the EU: Class I, Class IIa, Class IIb, Class III
There are three classes in the USA: Class I, Class II, Class III
There are three classes in China: Class I, Class II, Class III
There are four classes in Russia: Class I, Class IIa, Class IIb, Class III
There are four classes in Canada: Class I, Class II, Class III, Class IV
Is medical device classification different in various regions?
The exact details of medical device classification is different in different regions. So, please check the regulations that apply to your target market to determine the exact classification scheme.
As an example, we share information for four regions:
The rules for classifying your medical device in the EU is defined in Annex VIII of the European Medical Device Regulation.
Watch the MedTech Chat video on Changes in the New EU Medical Device Regulation for some insight how the classification of medical devices in the EU.
The rules for classifying your medical device in the US is defined by the FDA.
The rules for classifying your medical device in China is defined in Announcement No. 104/2017 or Order No.15.
Read the article In a Nutshell: Registering your Medical Device for Chinese Market for more about the certification of the different classes of medical devices.
The rules for classifying your medical device in Russia is defined in Order 4n, amended by Order 557n and GOST 31508-2012.
Read the blog article on How to Register Your Medical Device in Russia for more about the certification of the different classes of medical devices.
What are Class I medical devices?
Generally, Class I medical devices have the lowest risk of use ranging from low to moderate. This class of device has the least requirements for compliance.
Class I devices in different countries have different specific requirements, so please check the regulations that apply to your target market.
What are Class II medical devices?
Generally, Class II medical devices have a moderate to high perceived risk associated with its use. Class II medical devices has more requirements for compliance than Class I devices.
Class II devices in different countries have different specific requirements, so please check the regulations that apply to your target market.
What is the difference between Class I and Class II medical devices?
The main difference between Class I and Class II medical devices is in the perceived risk associated with their use. Class I devices have a low to moderate risk while Class II devices have a moderate to high risk.
What is a Class III medical device?
Generally, a Class III medical device has the highest perceived risk associated with its use. Class III medical devices usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury. These devices therefore are subject to more stringent requirements for compliance.
Class III devices in different countries have different specific requirements, so please check the regulations that apply to your target market.
If you would like more information on Medical Device Classification or need help classifying your medical device, please contact us at firstname.lastname@example.org. Our team of experts would be happy to help you.