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European Medical Device Classification 

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European Medical Device Classification 

In the European Union, medical devices are classified into different classes based on their potential risks and intended use. The classification system is outlined in the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). These regulations classify medical devices into four main classes: Class I, Class IIa, Class IIb, and Class III. 

In vitro diagnostic medical devices are classified into Classes A, B, C, and D. The classification criteria include factors such as the duration of contact with the body, whether the device is invasive or surgically invasive, whether it contains a medicinal substance, and the degree of risk associated with its use. 

The classification determines the conformity assessment route that manufacturers must follow to demonstrate compliance with regulatory requirements. 

European Medical Device Classification

Class I Devices

Low risk, non-invasive, everyday devices or appliances are classified as class I devices. The manufacturer is required to complete technical file for such devices. 

Class Is Devices

Class Is devices are comparable to class I devices. Additionally, they include sterile devices in this sub-group. These devices also require a technical file, as well as an application to a European Notified Body for manufacturing certification in accordance with sterility requirements. 

Class Im Devices

Similar low-risk measuring devices. The manufacturer must provide a technical file and be certified by a European Notified Body for manufacturing in accordance with metrology regulations. 

Class IIa Devices

Class IIa devices generally include low to medium risk and refer mainly to devices installed within the body in the short term. Class IIa devices are those which are installed within the body for only between 60 minutes and 30 days. Requirements are technical files and a conformity test carried out by a European Notified Body. 

Class IIb Devices

Slightly more complex than class IIa devices, class IIb devices are generally medium to high risk and will often be devices installed within the body for periods of 30 days or longer. Identical compliance route to class IIa devices with an added requirement of a device type examination by a Notified Body. 

Class III Devices 

Class III devices are strictly high risk devices. The steps to approval here include a full quality assurance system audit, along with examination of both the device’s design and the device itself by a European Notified Body.