PMPF — Post-market performance follow-up

The IVDR counterpart to PMCF: a continuous process of updating the performance evaluation using data gathered from the device in routine use, addressed in a PMPF plan and reported in a PMPF evaluation report that forms part of the performance evaluation report.

Reference: IVDR Annex XIII Part B

Positive predictive value

The ability of a device to separate true positive results from false positive results for a given attribute in a given population.

Reference: IVDR Article 2(52)

Predictive value

The probability that a person with a positive device test result has a given condition under investigation, or that a person with a negative device test result does not have a given condition.

Reference: IVDR Article 2(51)

RUO — Research use only

A product not intended for in vitro diagnostic examination and therefore outside the IVDR, unless the manufacturer specifically intends it for diagnostic use in view of its characteristics. Labelling a product research use only does not exempt it if its intended purpose is diagnostic.

Reference: IVDR Article 1(3)(a)

Scientific validity report

The report demonstrating the association between an analyte and the clinical condition or physiological state it is intended to identify. It is one of the three inputs the manufacturer assesses when establishing clinical evidence for an IVD.

Reference: IVDR Annex XIII Part A points 1.2.1 and 1.3.1

Scientific validity of an analyte

The association of an analyte with a clinical condition or a physiological state.

Reference: IVDR Article 2(38)

Specimen receptacle

A device, whether of a vacuum-type or not, specifically intended by its manufacturer for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination.

Reference: IVDR Article 2(3)

SSP — Summary of safety and performance

The IVDR counterpart to the SSCP, required for class C and class D devices other than devices for performance studies. It is validated by the notified body, uploaded to Eudamed, and its location must be stated on the label or in the instructions for use.

Reference: IVDR Article 29