Introduction to performance studies of IVD medical devices

Performance studies as a basis for performance evaluation

A performance evaluation is required for all in vitro-diagnostic (IVD) medical devices. Performance evaluation is a continuous process by which data are assessed and analysed to demonstrate the scientific validity, analytical performance and clinical performance of a device. 

As a general rule, the analytical performance must always be demonstrated on the basis of analytical performance studies.

Demonstration of the clinical performance of a device must be based on one or a combination of the following sources:

• Clinical performance studies.
• Scientific peer-reviewed literature.
• Published experience gained by routine diagnostic testing.

Clinical performance studies must be performed unless due justification is provided for relying on other sources of clinical performance data.

Detailed information on the requirements can be found in IVDR Article 56 and Part A of Annex XIII. 

What is a performance study?

A performance study is a study undertaken to establish or confirm the analytical or clinical performance of a device, cf. IVDR Article 2 (42). "Device" includes IVD medical devices and accessories for IVD medical devices, cf. IVDR Article 1 (2).

The terms analytical and clinical performance 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 product being investigated is an IVD medical device or an accessory for an IVD medical device according to the definitions in IVDR Article 2 (2) and 2 (4), or is investigated for one of the purposes covered by these definitions. More information on qualification of IVD medical devices and accesories can be found on our website qualification of medical devices.
2. The purpose of the study is to establish or confirm the analytical or clinical performance a 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.

Fees for applications for performance studies

There are no fees for applications and notifications of performance studies of IVD medical devices at NOMA.