MDR - annex VIII - article 1
Original text
Expert opinion
Definitions specific to classification rules
1. Duration of use
1.1. ‘Transient’ means normally intended for continuous use for less than 60 minutes.
1.2. ‘Short term’ means normally intended for continuous use for between 60 minutes and 30 days.
1.3. ‘Long term’ means normally intended for continuous use for more than 30 days.
Definitions of classification rules
To obtain and define the correct product risk classification for a medical device, the duration of use is important. According to the intended use, the medical device has an assigned duration of use. This duration can be classified into 3 groups, i.e. the transient, the short term and the long term use.
The duration of use per group is defined with a specific time. These boundaries are hard boundaries to classify the product correctly.
