Skip to content Norwegian Medical Products Agency Norwegian Medical Products Agency

Introduction to performance studies of IVD medical devices

Published:

Changes

A performance study is carried out to establish the analytical or clinical performance of an IVD. IVDR lists requirements for performance studies to ensure valid, reliable and robust generated data, and that the participaters rights are protected.

Page contents

    What is a performance study?

    A performance study is a study undertaken to establish or confirm the analytical or clinical performance of an IVD medical device (cf. IVDR Article 2 (42)). The terms are further defined in IVDR Article 2 (40) and 2 (41):

    Analytical performance means the ability of a device to correctly detect or measure a particular analyte.

    Clinical performance means the ability of a device to yield results that are correlated with a particular clinical condition or a physiological or pathological process or state in accordance with the target population and intended user.

    Does the study fall within the scope of IVDR?

    The study falls within the scope of IVDR if the following conditions are fulfilled:

    1. The device falls under the definition of an IVD medical device, or is investigated for one of the purposes covered by the definition. The definition can be found in IVDR Article 2 (2) and on our website Qualification.
    2. The purpose of the study is to establish or confirm the analytical or clinical performance of the IVD medical device, i.e. the study is a performance study as described in the previous section.

    What requirements apply to performance studies that fall within the scope of IVDR?

    All performance studies must fulfil the general requirements outlined in IVDR Article 57. 

    In addition, some performance studies may require an application or a notification to the Norwegian Medical Products Agency (NOMA). In general, this applies to performance studies that entail risks for the subjects of the study. 

    Performance studies may also require an application to the Norwegian Ethics Committees for Clinical Trials on Medicinal Products and Medical Devices (REK KULMU).

    More information can be found on our websites Performance studies which require an application, Performance studies which require a notification and Other performance studies. 

    Clinical performance studies should be prepared in accordance with good study practice as described in the standard ISO 20916:2019 In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice.

    EU regulations on medical devices