In Vitro Diagnostics

A performance evaluation is required by REGULATION (EU) 2017/746 of 5.5.2017 (Corrigenda L 117/11 of 3.5.2019 and L334/167 of 27.12.2019) on in vitro diagnostic medical devices (IVDs) and repealing Directive 98/79/EC and Commission Decision 2010/227/EU for each in vitro diagnostic medical device (IVD Directive, IVDR), regardless of product class.

According to Annex XIII, performance evaluation is an ongoing and important process by which data are assessed 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 must be drawn up by the manufacturer and kept up to date. In the performance evaluation plan, the performance evaluation is planned, continuously performed and documented. The performance evaluation plan shall 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) within the framework of performance evaluation tests according to EN 13612:2002 or ISO 20916 (clinical performance study on human test material, good study practice, harmonization until 26.5.2022), Medizinprodukte-Durchführungsgesetz (MPDG) and, in the case of in-vitro diagnostics, transitionally until the start of validity of Regulation (EU) 2017/746 on 26 May 2022 according to §§20 to 24 of the Medizinproduktegesetz (MPG)(printed matter 19/17589 of 4.3.2020).

In vitro diagnostics are for example:

- Tests for the diagnosis of SARS-CoV2 (coronavirus, CoV-19), incl. newer mutations
- Early cancer diagnostics

Art. 56, para. 3 of the IVDR defines the process of a performance evaluation according to Annex XIII, Part A, para. 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.

With a focus on clinical evidence, the aim is to achieve international regulatory alignment (in particular with the WHO's Global Harmonization Task Force (GHTF)), contributing to a high level of safety and ease of trade worldwide.

The purpose of a Clinical Performance Study is to establish or confirm aspects of a product's performance 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 Art. 56 (3).

Definitions for groups of people in a performance study.

Data generated during clinical performance studies are used as part of the performance evaluation process and are part of the clinical evidence for the product.

Clinical evidence, performance evaluation, and performance studies.

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