Framework

IVDR — Performance Studies

The EU IVDR 2017/746 establishes the regulatory framework for conducting performance studies of IVD medical devices. It defines the requirements for performance study applications, sponsor and investigator obligations, subject protection, ethics committee review, and the reporting of adverse events and device deficiencies during performance studies conducted to generate clinical evidence.

Overview

Background

Under Regulation (EU) 2017/746, performance study requirements were significantly expanded compared to the minimal provisions in the IVD Directive. The regulation introduced a structured application process, enhanced subject protection requirements, and coordinated multi-state assessment procedures, aligning IVD performance study requirements with the clinical investigation framework for medical devices under the MDR.

Applicability

These requirements apply to sponsors, investigators, and ethics committees involved in performance studies of IVD devices conducted in the EU. They cover interventional clinical performance studies, other performance studies involving risks to subjects, and studies of companion diagnostics. The requirements also address studies of devices already bearing CE marking being studied for new intended purposes.

Core Principles

Performance study application process

Ethics committee approval requirements

Informed consent and subject protection

Sponsor and investigator responsibilities

Adverse event and device deficiency reporting

Interventional vs. non-interventional study requirements

Performance study documentation and records

Coordinated multi-state assessment procedure