This page is no longer maintained. On 26 May 2022 the EUIVDR entered into application and the IVDD was repealed.
Similar to the introductory remarks on Performance evaluation: While the current In Vitro Diagnostic Directive (IVDD) implies that performance evaluation data will be derived from performance studies, it doesn’t explicitly require it. Those familiar with the current IVDD will of course point to the current Annex III (3), the requirement for the Technical Documentation to contain “...adequate performance evaluation data… from studies in a clinical or other appropriate environment”. As well as the requirement in Annex VIII (2), to list the “...laboratories or other institutions taking part in the evaluation study,”. But there is no Article in the current IVDD which explicitly requires the conduct of a performance evaluation study. In contrast, Article 56 (4) of the new In Vitro Diagnostic Regulation (IVDR) makes the conduct of Clinical performance studies virtually a default requirement,“unless it is duly justified to rely on other sources of clinical performance data”.
Any manufacturer/sponsor planning to conduct a performance study must review Articles 57 to 77. These articles contain many specific requirements applying to performance studies, including but not limited to; requirements for studies which obtaining specimens poses a particular risk for the subject, requirements for reporting adverse events occurring in a performance study, requirements for performance studies involving vulnerable subjects.
The new Annex XIII part A (2) contains considerable detail on the planning and reporting of clinical performance studies. Especially for the Clinical Performance Study Plan (CPSP) for which there is a list of twenty eight requirements, as well as the requirement to produce as Clinical performance study report at the end of the study. However, many of these requirements are not really new, at least not to manufacturers of devices listed in Annex II of the current IVDD. Those manufacturers will already be familiar with the very similar requirements defined by the harmonised standard EN 13612:2002 “Performance evaluation of in vitro diagnostic medical devices”.
Not all performance studies are Clinical performance studies of course. There are also Analytical performance studies. Annex I chapter II (9) identifies those performance characteristics which the legislators consider to be analytical performance characteristics and those they consider to be clinical performance characteristics. The new Annex XIII part A (3) addresses those other studies. But the requirements are virtually the same. At least by analogy, there is a requirement for an Analytical Performance Study Plan (APSP) and Analytical performance study report.
Finally, there is another type of performance study anticipated in the new IVDR: The Interventional clinical performance study. This is a clinical performance study in which the test results are intended to be used in patient management or treatment. This can be the case for example in the co-development of a so called personalised medicine. When the clinical trial of the Investigational Medicinal Product (IMP) is combined with the Clinical performance study of the companion IVD. In such cases, Annex XIV chapter I contains several pages of additional requirements which must be fulfilled by the sponsor. In addition to the requirements of Annex XIII A (2) and (3) described above.