Performance evaluation of in-vitro diagnostics (IVD)

The performance evaluation of in vitro diagnostic medical devices is an essential part of the life cycle of an in vitro diagnostic medical device (IVD) and is intended to fulfil the basic safety and performance requirements.

For IVDs, performance evaluations assess scientific validity, analytical and clinical performance.

According to REGULATION (EU) 2017/746 of 5 May 2017 (Corrigenda L 117/11 of 3 May 2019 and L334/167 of 27 December 2019) on in vitro diagnostic medical devices (IVD) and repealing Directive 98/79/EC and Commission Decision 2010/227/EU, a performance evaluation is required for each in vitro diagnostic medical device (IVD Directive, IVDR) regardless of the product class.

According to Annex XIII of the IVDR, performance evaluation is an ongoing and important process by which data are assessed and analysed to demonstrate scientific validity, analytical performance and clinical performance in relation to the intended purpose. This process serves to fulfil the Essential Safety and Performance Requirements of IVDR EU 2017/746.

For this purpose, a performance evaluation plan must be created and kept up to date by the manufacturer. The performance evaluation is planned, continuously performed and documented in the performance evaluation plan. The performance evaluation plan sets out 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 studies in accordance with EN 13612:2002 or ISO 20916 (clinical performance study on human test material, good study practice, harmonisation until 26 May 2022), Medical Devices Implementation Act (MPDG).

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 procedure 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 assessed and analysed to demonstrate the scientific validity, analytical performance and clinical performance of that device in relation to the intended purpose stated by the manufacturer.

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

Purpose of a clinical performance study

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

The data obtained from conducting clinical performance studies are used in the performance evaluation process and are part of the clinical evidence for the device.

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