One of the most important steps in bringing a medical device to market in the European Union (EU) is determining the correct classification for your device.
The EU medical device classification system is similar to the FDA’s system of classification, but it also has some substantial differences. If you want to avoid delays and hangups in getting your device to market in the EU, it’s essential you have a thorough understanding of how your device should be classified.
So, let’s dive into what you need to know about the EU classification system for medical devices.
Understanding the MDR risk class system
In the EU, medical devices are regulated by the European Commission (EC). Back in 2017, the EC set forth it’s new regulations for medical devices—The European Union Medical Device Regulation, or EU MDR 2017/745. The MDR, as it’s commonly referred to, is the document that covers medical device classification in the EU, and it supersedes the existing Medical Device Directive (MDD).
The MDR stipulates that a medical device must receive a CE marking in order to be legally sold on the EU market. The acronym CE stands for Conformité Européene, which translates to “European conformity.” Basically, in order to obtain the CE mark, a conformity assessment will need to be conducted based on the risk class of the medical device to ensure it complies with all applicable regulations required by the MDR.
What are the different risk classes and CE marking routes?
There are a number of different routes of assessment to obtain CE marking for your product, and the route you take depends on the risk class of your device under the MDR.
The MDR designates four medical device classifications:
Each of these risk classes requires a different conformity assessment route, which will determine the steps you’re required to take for CE marking.
In many cases, the route to a CE marking requires the involvement of a notified body—an independent organization designated under the new Regulation to assess the conformity of certain products in the EU.
Class I Medical Devices
Class I medical devices in the EU have the lowest perceived risk. In many cases, the manufacturer can self-certify Class I devices without the involvement of a notified body. This risk class includes products like stethoscopes, bandages, or glasses.
However, there are three more sub-classifications within Class I medical devices that have a slightly higher perceived risk and do require the involvement of a notified body before the manufacturer can affix the CE marking.
The sub-classifications for Class I devices are as follows:
Class Is: The medical device must be presented sterile.
Class Im: The medical device has a measuring feature.
Class Ir: The medical device is a reusable surgical instrument.
Class IIa Medical Devices
Class IIa medical devices are considered medium-risk devices by the MDR. This means that unlike a Class I device, the manufacturer must receive a declaration of conformity from a notified body following its conformity assessment. Examples of this risk class include catheters, hearing aids, or short-term contact lenses.
Class IIb Medical Devices
As you may have guessed, Class IIb medical devices are considered medium- to high-risk devices under the MDR, and thus their CE route also requires the involvement of a notified body. This risk class includes devices like incubators, insulin pens, long-term contact lenses, and ventilators.
Class III Medical Devices
Last, but certainly not least, are the Class III medical devices. Just like the FDA classification system, Class III devices are considered high-risk and are subject to the most stringent requirements, including clinical evaluation of the device.
This risk class includes devices like pacemakers, prosthetic heart valves, surgical mesh, breast implants, and other devices that require permanent monitoring throughout their lifetimes.
How does the EU rule-based class system work?
The EU uses a rules-based system for determining the risk class of a medical device. In Annex VIII of the MDR, you’ll find 22 rules for classifying any medical device.
The rules are divided into four sections, and the rules of each section apply to a specific category of devices.
Rules 1-4 cover non-invasive devices.
Rules 5-8 cover invasive devices.
Rules 9-13 cover active devices.
Rules 14-22 are special rules that cover devices that do not fall into the first three categories, such as nanomaterials.
Additionally, the duration of the device’s use is used to determine which rule(s) apply within a given category. The three types of duration specified in the MDR are:
Transient: Intended for continuous use for less than 60 minutes
Short Term: Intended for continuous use for between 60 minutes and 30 days
Long Term: Intended for continuous use for more than 30 days
Choose the rule(s) most applicable to your device in order to determine the risk class of your medical device in the EU. If several of the rules apply to a device, the MDR stipulates that you should use the strictest rule that results in the highest level of classification.
Determine medical device class and obtain CE marking with ease
If you’re concerned about which risk class category your medical device falls into or the route you’ll take to get your CE marking to place your device on the EU market, Greenlight Guru is here to help.
The Medical Device Success Platform (MDSP) from Greenlight Guru is the only industry-specific solution of its kind. The cloud-based software is aligned with the latest industry standards and provides full traceability throughout the lifecycle of your medical device—a new requirement of the MDR that no other solution can match.
Get in touch with us today to get your free demo!
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