MDR Annex VIII (Classification Rules)

The rules that sort devices into class I, IIa, IIb, or III. Chapter I defines terms such as duration of use, Chapter II covers applying the rules, and Chapter III sets out 22 classification rules.

Duration of use

Transient

Normally intended for continuous use for less than 60 minutes.

Short term

Normally intended for continuous use for between 60 minutes and 30 days.

Long term

Normally intended for continuous use for more than 30 days.

Where it is written

Regulation (EU) 2017/745, Annex VIII (consolidated text of 10 January 2025)

Also called

Annex VIII, device classification rules, MDR classification rules

Related terms