Device for near-patient testing

Near-patient tests have additional requirements under the IVDR, for example on usability by the intended professional users. They differ from self-tests, which are used by lay persons.

‘device for near-patient testing’ means any device that is not intended for self-testing but is intended to perform testing outside a laboratory environment, generally near to, or at the side of, the patient by a health professional;

IVDR, Article 2(6)