What is Clinical Performance?

In the Article 2 of the European Regulation IVDR 2017/746, clinical performance is defined as: “the ability of a device to yield results that are correlated with a particular clinical condition, a physiological or pathological process, or in accordance with the target population and intended user.” 

After demonstrating analytical performance, the IVD manufacturer must plan Cclinical performance studies. The purpose of a clinical performance study is to establish and confirm aspects of the IVD medical device that cannot be addressed with the analytical performance data, literature, and/or experience gained by routine diagnostic testing. The clinical performance studies are to be performed in circumstances similar to the normal conditions of use of the device. 

Annex XIII states that demonstration of the clinical performance of a device should 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 (as stated in Annex XIII).

The IVDR 2017/746 requires that clinical performance studies be performed unless the manufacturer can give valid justifications as to why they are not needed. Only in the case of established tests where the equivalence can be demonstrated, manufacturers may rely on other sources of clinical performance data. It should be kept in mind that planning, conducting, and executing clinical performance studies takes a lot of time and manufacturers must start the process well in advance 

How can Cerba Xpert support you in your Clinical Performance Studies?

Cerba Xpert can act as sponsor, investigator or CRO on demand by the customer. 

Cerba Xpert can: 

• Design the clinical study protocol and obtain the necessary regulatory approvals and ethics committee approvals, without this the study cannot proceed. These are formal written approvals.
• Find the appropriate sites with the right capabilities and then engage with them for conducting the studies.
• Can design consent forms and obtain informed consents from the participants who enroll into this clinical study.
• Can manage the entire program from writing the Clinical Performance Study Plan (CPSP) to the Clinical Performance Study Report (CPSR) with complete details about the clinical performance study protocol plan, results, and conclusions.