EU IVDR – Clinical Evidence and Performance Evaluation

Manufacturers shall establish and update a performance evaluation plan specifying the characteristics and the performance of the device and the process and criteria applied to
generate the necessary clinical evidence. The performance evaluation report shall be part of the technical documentation and will be also a key part of the initial submissions to the Notified Body.

The document is intended to provide confirmation of conformity with relevant General Safety and Performance Requirements for the following:

1. Normal conditions of the intended use of the device
2. Evaluation of the interference(s) and cross-reaction(s)
3. Acceptability of the benefit-risk ratio

This living process shall be conducted on continuous basis and shall be kept updated through the implementation of the post market surveillance (PMS) and the post market performance follow up (PMPF).

Main reference guidance documents that provides information on the definitions and expectations of content for clinical evidence and which may be used as reference material are:

• 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

GHTF = Global harmonization Task Force; now re-convened as the International Medical Devices
Regulators Forum (IMDRF).
For IMDRF guidance documents for clinical evaluation see:
http://www.imdrf.org/documents/doc-ghtf-sg5.asp

Reference standard defining 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 (IVD) medical devices for regulatory purposes is:

• ISO 20916:2019 In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice