Device Classification (EU)

The EU MDR divides devices into classes I, IIa, IIb, and III by intended purpose and inherent risk. The classes come from 22 rules in Annex VIII. The manufacturer states the class and the rules applied in the technical documentation.

Examples from the rules

Class I

Non-invasive devices unless another rule applies (Rule 1), and other active devices (Rule 13).

Class IIa

Surgically invasive devices for transient or short-term use, unless an exception applies (Rules 6 and 7). Software that provides information for diagnostic or therapeutic decisions, unless the decisions could have a serious impact (Rule 11).

Class IIb

Implantable devices and long-term surgically invasive devices, unless an exception applies (Rule 8). Devices for contraception or preventing sexually transmitted diseases (Rule 15).

Class III

Active therapeutic devices with an integrated diagnostic function that significantly determines patient management, such as closed-loop systems or automated external defibrillators (Rule 22). Devices made with non-viable tissues or cells of human or animal origin, with exceptions (Rule 18).

Where it is written

Regulation (EU) 2017/745, Article 51(1); Annex VIII, Chapter III; Annex II, Section 1.1(f) (consolidated text of 10 January 2025)

Also called

MDR device class, Class IIa, Class IIb

Related terms