Although conducting a pre-market Performance Evaluation is already required by the current In Vitro Diagnostics Directive (IVDD), none of the Articles in the IVDD explicitly require it. Of course it wouldn’t be possible to fulfil the IVDD without a comprehensive evaluation of the device’s performance. Including for example; the Essential Requirement to demonstrate performance in Annex I A (3), the labelling requirements in Annex I B (8.7 h), or the requirement for the Technical Documentation to contain adequate performance evaluation data in Annex III (3). But the IVDD’s requirement for performance evaluation is implied, rather than explicitly stated, and primarily concerned with the device’s analytical performance.
In the new European Union In Vitro Diagnostics Regulation (EU IVDR) however, the requirement to conduct a pre-market Performance Evaluation is explicitly stated in the new Article 56 (1) and is detailed in the new Annex XIII. But before jumping directly to Annex XIII, it is worth reading the second and third paragraphs of Article 56 too. Together, the first three paragraphs of Article 56 clarify the expectations for performance evaluation in the new IVDR.
Article 56 paragraph 1 introduces three new terms which are not present in the current IVDD; scientific validity, clinical performance and clinical evidence. Paragraph 2 clarifies that the purpose of the performance evaluation is to produce the “clinical evidence” that supports the manufacturer’s intended use (not just the analytical performance claims). Paragraph 3 further clarifies that the performance evaluation has three components; the data that demonstrates the “Scientific validity” of the test, the data that demonstrates “Clinical performance” of the test, and the data that demonstrates the “Analytical performance” of the test. Helpfully, all of these new terms are defined in Article 1 (36) – (41) and, the methods to be followed to demonstrate these various attributes are also described in the new Annex XIII.
Part A of the new Annex XIII is focussed on the pre-market phase and defines the performance evaluation as a three step process; (1) planning the performance evaluation, (2) collecting the data that demonstrates the scientific validity and the analytical and clinical performance – see the separate page on performance studies, and (3) assessing and reporting on the data which has been collected. The result is the Performance Evaluation Report. Within the Performance Evaluation Report the manufacturer demonstrates the sufficiency of the clinical evidence that supports the manufacturer’s intended use for the device in medical practice.
Part B of the new Annex XIII is focussed on the post-market phase and describes the requirement for Post Market Performance Follow-up (PMPF). While PMPF is another new new term not found in the current IVDD, the current practice of many manufacturers to conduct a periodic “state of the art” review is clearly in line with the concept of PMPF. Post Market Performance Follow-up is the concept by which the manufacturer continuously reviews the Performance Evaluation Report to ensure it reflects the state of the art. The manufacturer is required to have a Post Market Performance Follow-up Plan, and to produce a Post Market Performance Follow-up Evaluation Report. It is important to note that there is a difference between Post Market Performance Follow-up (PMPF) and Post Market Surveillance (PMS) which described on a separate page. PMPF being an important element of PMS.