Expected erroneous results

Manufacturers must state these in the product information and quantify them in the technical documentation. Individual expected erroneous results are not reported one by one, but a significant increase in their frequency or severity falls under IVDR trend reporting.

Expected erroneous results are established in comparison to the stated performance of the device as referred to in points (a) and (b) of Section 9.1 of Annex I of the IVDR and must be clearly documented and quantified in the product information and the technical documentation. They should also be acceptable when weighed against the evaluated benefits to the patients and/or user arising from the achieved performance of the device during normal conditions of use (Section 8 of Annex I IVDR).

MDCG 2023-3 Rev.2, Question 9