Clinical performance studies for IVDs

Clinical performance studies are performed on the basis of a clinical performance study plan (CPSP). According to the IVDR, the purpose of clinical performance studies is to establish or confirm aspects of device safety and performance which cannot be determined by analytical and clinical performance studies, literature and/or previous experience gained by routine diagnostic testing. When clinical performance studies are conducted, the data obtained is used in the performance evaluation process and forms an important part of the clinical evidence.

Bring us in at an early planning stage and we will ensure that your study follows a sustainable design and produces valid data. Our scientists are experienced and will quickly familiarize with your product so that we are able to support you effectively in developing a study plan. During the study we are available as a competent partner for your test laboratory and provide regular updates about the study so that you may fully concentrate on your core competences.

NEW: ISO 20916:2019

In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice
This document defines good study practice for the planning, design, conduct, recording and reporting of clinical performance studies carried out to assess the clinical performance and safety of in vitro diagnostic medical devices (IVDs).
More about IVDR

Performance study: yes or no? Use our quick check!

Is there performance data according to Annex I (9, 20) that could not be determined by analytical performance studies, clinical performance studies, literature and/or (published)routine tests?

NO, all required necessary data is available.

-> Justify why you do not consider a clinical performance study necessary.

YES, some data could not be determined.

-> Then check the following strategies for your product:

  • Comparison with an equivalent product has already been investigated in a clinical study? Then technical documentation is required.
  • For products on the market that require confirmation or confirmation of a request, create a PMPF plan to confirm your data.

Please note: For novel markers/novel technologies, a performance study is always required.

Assistance with the question whether a performance study is necessary is also provided by the GHTF.

For the GHTF (Global Harmonization Task Force) the need for clinical performance depends on the degree of standardization of the respective test:
  • For an established and standardized test, clinical performance is not required to demonstrate compliance with the relevant basic requirements.
  • For an established and non-standardized test, clinical performance is often required to demonstrate compliance with the relevant basic requirements.
  • For a new type of test, clinical performance is most likely required to demonstrate compliance with the relevant basic requirements.

Standards and directives

  • GHTF/SG5/N6:2012: Clinical Evidence for IVD medical devices – Key Definitions and Concepts
  • GHTF/SG5/N7:2012: Clinical Evidence for IVD medical devices – Scientific Validity Determination and Performance Evaluation
  • GHTF/SG5/N8:2012: Clinical Evidence for IVD Medical Devices - Clinical Performance Studies for In Vitro Diagnostic Medical Devices

How may we support you?

  • Preparing the registration documents for products for clinical investigation for the approval process at the German Federal Institute for Drugs and Medical Devices (BfArM) and the ethics commission,
  • Preparing the clinical tester manual or the investigator brochure in accordance with ISO 14155,
  • Providing advice on the selection of test centers and contact to test centers,
  • Preparing the final study report.

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