A “device for near-patient testing” is defined in Article 2 No. 6 of the IVDR as “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”.
By using it outside of the traditional clinical laboratory, for example, a shortened Turn-around-Time can improve patient care and at the same time save costs. For the approval of a device intended for NPT, in addition to the conformity assessment compliant with the applicable procedure listed in Annexes IX to XI IVDR, the manufacturer must also follow the procedure for assessing the technical documentation specified in Annex IX, Section 5.1.
The unique infrastructure of Biomex GmbH makes it possible to support manufacturers in the conformity assessment of their IVDs for near-patient testing in a 360° approach. Contact us!