Framework

MDR — Classification

The EU MDR 2017/745 establishes the classification system for medical devices based on their intended purpose, inherent risks, and invasiveness. Annex VIII defines the classification rules that assign devices to one of four risk classes (I, IIa, IIb, III), which determines the conformity assessment route, the level of regulatory scrutiny, and the obligations of the manufacturer.

Overview

Background

Under Regulation (EU) 2017/745, the classification system was updated from the former Medical Devices Directive to include new rules addressing emerging technologies such as nanomaterials, software, and substance-device combinations. The regulation expanded the number of classification rules and reclassified certain device types to higher risk classes to ensure appropriate regulatory oversight.

Applicability

These classification rules apply to all medical devices intended for the EU market. Manufacturers must determine the correct classification for each device before initiating the conformity assessment process. The classification determines which conformity assessment procedure applies and whether a notified body must be involved. Competent authorities and notified bodies may also make classification decisions in cases of dispute.

Core Principles

Risk-based classification approach

Classification rules by device type and invasiveness

Duration of contact considerations

Active device classification criteria

Software classification rules (Rule 11)

Nanomaterial and substance-device rules

Implementing and interpreting classification rules

Reclassification and boundary case resolution