Clinical Performance Studies

The purpose of clinical performance studies is to establish or confirm aspects of device performance which cannot be determined by analytical performance studies, literature and/or previous experience gained by routine diagnostic testing. This information is used to demonstrate compliance with the relevant general safety and performance requirements with respect to clinical performance. When clinical performance studies are conducted, the data obtained shall be used in the performance evaluation process and be part of the clinical evidence for the device.

Manufacturer/sponsor is responsible for the:

  • Design of the Performance Study Plan CPSP)
  • Designation of principal investigator
  • Insurance
  • Obtaining the authorization from the Competent Authorities in accordance with Article 66 for the following studies:

    •  in which surgically invasive sample-taking is done only for the purpose of the performance study;
    • that is an interventional clinical performance study as defined in point (46) of Article 2; or
    • where the conduct of the study involves additional invasive procedures or other risks for the subjects of the studies,
    • Performance studies involving Companion Diagnostic

 

  • Application with ethical committee
  • The non-EU manufacturer/sponsor may choose to appoint the Authorized Representative to seek authorization on his behalf to perform the performance studies.
  • Serious adverse events occurring during the performance studies must be reported by the sponsor or the appointed Authorized Representative through the EUDAMED database
  • The Performance study report should be incorporated in the technical documentation that has to be kept available by the manufacturer and his appointed European Authorized Representative established within the Union.
  • Sponsor (or the authorized representative) shall notify the competent authorities of the ending of the clinical investigation, and submit a report.

Authorities are responsible to give authorization for the Performance Studies to start, after registration in the European Databank.  Delegated acts may be taken by the commission to fine tune this procedure. The Performance Study will receive a single registration number (SRN) for better follow-up and data exchange between member-states.

Clinical investigation and evaluation are reviewed by the Notified Body when the conformity assessment procedure does include an assessment of the technical documentation.

in In-Vitro Diagnostic Medical Device Regulation