In Vitro Diagnostics

Evaluating the performance of in vitro diagnostic medical devices (IVDs), regardless of product class, is required by the Regulation (EU) 2017/746 in place since 5/5/2017 (Correction from L 117/11 of 5/3/2019 and L334/167 of 12/27/2019). The new Regulation repeals the Directive 98/79/EC and Commission Decision 2010/227/EU.

According to Annex XIII, performance evaluation is an ongoing and important process by which data are evaluated and analyzed to demonstrate scientific validity, analytical performance, and clinical performance related to intended purpose. This process is used to meet the Essential Safety and Performance Requirements of the IVDR EU 2017/746.

For this purpose, a performance evaluation plan shall be prepared and kept updated by the manufacturer. In the performance evaluation plan, the performance evaluation is planned, continuously performed and documented. The performance evaluation plan should outline the characteristics and performance of the device and the procedures and criteria that will be used to provide the required clinical evidence.

We conduct clinical studies (performance studies) as part of performance evaluation tests in accordance with EN 13612:2002 or ISO 20916 (clinical performance study on human test material, good study practice, harmonization until May 26, 2022), German Medical Devices Implementation Act (translated by MEDIACC, Medizinprodukte-Durchführungsgesetz [MPDG]) and, in the case of in vitro diagnostic medical devices, transitionally until the start of validity of Regulation (EU) 2017/746 on May 26, 2022 in accordance with Sections §§ 20 to 24 of the German Medical Devices Act (printed matter 19/17589 of March 4, 2020).

Such in vitro diagnostic devices are for example:

       - Tests for the detection and diagnosis of SARS-CoV2 (coronavirus, CoV-19), incl. more recent mutations

       - Early cancer diagnostics

Art. 56(3) of the IVDR defines the process of a performance evaluation according to Annex XIII, Part A, Sec. 1. defines performance evaluation of a device as an ongoing process by which data are evaluated and analyzed to demonstrate the scientific validity, analytical performance, and clinical performance of that device with respect to its intended purpose as stated by the manufacturer.

Concentrating on clinical evidence, the aim is to achieve international regulatory alignment (in particular with the WHO Global harmonization task force (GHTF)) with a contribution to a high level of safety and ease of trade worldwide.

The purpose of a clinical performance study is to establish or confirm the performance aspects of a device that cannot be established from analytical performance studies, literature, and/or experience gained from routine diagnostic testing.

Other important definitions for performance studies that are relevant to clinical evidence in the performance evaluation under Article 56 (3).

Definitions for groups of subjects in a performance study.

Data generated during the conduct of clinical performance studies are used in the performance evaluation process and are part of the clinical evidence for the device.

Clinical evidence, performance evaluation, and performance studies.