Framework

MDR — Clinical Investigation

The EU MDR 2017/745 establishes the regulatory framework for conducting clinical investigations of medical devices in the European Union. It defines the requirements for clinical investigation applications, sponsor and investigator obligations, informed consent, ethics committee review, and the reporting of adverse events during investigations, ensuring subject safety and data integrity.

Overview

Background

Under Regulation (EU) 2017/745, the requirements for clinical investigations were significantly enhanced compared to the previous directives. The regulation introduced a coordinated assessment procedure for multi-country investigations, strengthened subject protection requirements, and established more detailed reporting obligations, aligning with international good clinical practice principles.

Applicability

These requirements apply to sponsors, investigators, and ethics committees involved in clinical investigations of medical devices conducted in the EU. They cover pre-market clinical investigations for CE marking purposes, post-market clinical follow-up (PMCF) studies that qualify as clinical investigations, and investigations of devices already bearing CE marking being studied for new intended purposes.

Core Principles

Clinical investigation application process

Ethics committee approval requirements

Informed consent and subject protection

Sponsor and investigator responsibilities

Adverse event and device deficiency reporting

Coordinated multi-state assessment procedure

Clinical investigation documentation and records

Corrective and preventive measures during investigation