Lay person

Devices meant for lay persons face extra requirements on design, instructions and usability. For IVDs, self-testing devices used by lay persons are placed in a higher class.

‘lay person’ means an individual who does not have formal education in a relevant field of healthcare or medical discipline;

EU MDR, Article 2(38)

‘lay person’ means an individual who does not have formal education in a relevant field of healthcare or medical discipline;

IVDR, Article 2(31)

individual who does not have formal education in a relevant field of healthcare or medical discipline and, if appropriate, relevant specialized training on the use of the specific medical device

ISO 20417:2021, clause 3.13