Guidance on classification of medical devices

The document works through each classification rule with examples and decision logic, addressing recurring questions such as whether software is an accessory, how invasive devices are assessed, and when a device falls into class III.

It clarifies that classification depends on the intended purpose as stated by the manufacturer, and that the most stringent applicable rule determines the class. Where several rules apply, the manufacturer must document the reasoning rather than defaulting to the lowest class.

Software classification is treated in detail: software that provides information used for diagnostic or therapeutic decisions is generally assessed as active, and the consequence of an incorrect decision drives the class. Software intended for administrative or lifestyle purposes is not a medical device.

Competent authorities and notified bodies use the guidance as a common reference, but it does not replace the regulation. Manufacturers are expected to record their classification rationale in the technical documentation so that it can be reviewed during conformity assessment.