How Are Medical Devices Classified Under EU MDR?

The European Commission (EC) introduced new regulations in 2017 known as the EU MDR 2017/745, which replaced the existing Medical Device Directive (MDD). Under the EU MDR changes, medical devices must now receive a CE marking to be legally sold in the EU.

To obtain this prestigious mark, a thorough conformity assessment must be carried out based on the device’s risk class to ensure that all applicable regulations required by the MDR are met.

Explaining EU MDR Classification Rules

Understanding the EU MDR classification rules is essential to ensure compliance with regulations to obtain a CE mark and legally commercialize your device in the European market.
Guidance document MDCG 2021-24 contains 22 rules that focus on a specific medical device category. Non-invasive devices are covered by rules 1-4, while invasive devices fall under rules 5-8. Active devices are classified using rules 9-13, and special rules (14-22) apply to devices not falling into these categories, such as nanomaterials.

The duration of device use is also taken into account. Devices can be categorized as:

Transient (used for less than 60 minutes)
Short term (60 minutes to 30 days)
Long term (more than 30 days)

To determine the risk class of your medical device in the EU, choose the most applicable rule(s) based on its category and duration of use. If multiple rules apply, the strictest one resulting in the highest classification level should be followed.

Medical Device Categories Under EU MDR

The MDR classifies medical devices into the following four risk categories:

Class I Medical Devices
Class IIA Medical Devices
Class IIB Medical Devices
Class III Medical Devices

Each class requires a different conformity assessment route, which determines the steps you need to take for CE marking.

Class I Medical Devices

Class I medical devices in the EU have the lowest perceived risk, so they can be self-certified by the manufacturer without the involvement of a notified body.

Some examples of Class I medical devices include:

Stethoscopes
Bandages
Glasses

There are also three sub-classifications within Class I devices that have a slightly higher perceived risk, meaning they require the involvement of a notified body before the manufacturer can affix the CE marking.

Sub-classifications for Class I medical devices include:

Class Is: Devices under this sub-classification, such as colostomy bags and oxygen masks, must be presented sterile to ensure that the device is free from any harmful particles or bacteria.
Class Im: Devices under this sub-classification have features used to measure different parameters, such as blood pressure or glucose levels, and require the involvement of a notified body to ensure accuracy and reliability.
Class Ir: Devices under this sub-classification are reusable surgical instruments, such as clamps and saws, that require proper sterilization and maintenance procedures to prevent the spread of infections during surgeries.

Using disposable medical devices can help you reduce surgical site infections significantly. Take a deep dive into SSIs and how to prevent them with single-use medical devices in our blog here.

Class IIA Medical Devices

Class IIa devices are considered medium-risk, meaning manufacturers need to obtain a CE certificate from their Notified Body. Once the manufacturer has obtained the certificate from the Notified Body, they are authorized to apply a CE mark to the medical device and/or its labeling.

Some Class IIA medical device examples include:

Catheters
Hearing aids
Short-term contact lenses

To obtain a CE mark for Class IIa devices, you need to:

Prepare a Technical File that demonstrates conformity with the EU’s requirements.
Partner with an Authorized Representative based in an EU member state
Complete a Notified Body Audit on your Quality Management System (QMS) and Technical File.
Secure your CE mark and obtain a Unique Identifier (UDI) after your manufacturer registers your device in the EUDAMED database.

Class IIB Medical Devices

Class IIb medical devices are classified as medium- to high-risk devices under the MDR and require the involvement of a notified body when it comes to the CE route. Class IIb devices include life-saving equipment, some implantable devices, and other higher risk devices that patients may use for longer than 30 days, such as incubators, insulin pens, long-term contact lenses, and ventilators.

Class IIb medical devices require a similar level of control as Class IIa devices, meaning you’ll need to prepare a Technical File, work with an Authorized Representative in the EU, complete a Notified Body Audit, and apply a CE mark and UDI for your device.

The use of laser marking has become widespread to affix CE marks on medical devices. At Remington Medical, we focus on creating lasting solutions, and laser marking technology is one of our best examples.

Our Laser Marking Solutions

Class III Medical Devices

Class III medical devices are subject to the most stringent EU regulations and requirements. This category includes life-changing devices such as pacemakers, prosthetic heart valves, surgical mesh, and breast implants. Class III medical devices must undergo extensive clinical evaluations to obtain a CE mark to legally market in the EU.

Key Takeaways

To comply with regulatory requirements and accelerate your product’s path to market, proper device classification is a must. But navigating the EU MDR device classification process on your own is daunting and takes a lot of time, especially if you run into roadblocks.

Whether you’re marketing your device in the US or EU, Remington Medical is your single-source manufacturer of record. From helping you classify your device to working with our notified body to ensure you meet the CE marking requirements, we’ve got you covered. Contact us today to learn more about how we can help you navigate the EU medical device classification process.