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.

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.