Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)

Overview

The In Vitro Diagnostic Medical Devices Regulation (IVDR) establishes a comprehensive regulatory framework for in vitro diagnostic medical devices (IVDs) in the EU. It introduces risk-based classification (Class A through D, with D being highest risk), requirements for clinical evidence and performance studies, enhanced oversight of notified bodies, unique device identification (UDI), and new obligations for manufacturers and sponsors. The regulation strengthens requirements for genetic testing and companion diagnostics. Regulation (EU) 2017/746 applies from 26 May 2022 with phased transitional periods for legacy devices.

This eu regulation (32017R0746) is part of the EU’s legal framework governing medical devices. EU medical devices regulation establishes a robust regulatory framework for the safety and performance of medical devices and in vitro diagnostic medical devices.

Type: EU Regulation

CELEX Number: 32017R0746

Date of Effect: See the official publication in the Official Journal of the European Union.

Key Provisions

Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establishes the core legal framework in this field. For specific provisions, articles, and implementing measures, consult the full text on EUR-Lex.

Significance

This legislation represents a key component of EU law in the area of medical devices. It reflects the EU’s approach to harmonization and regulatory policy within the internal market framework.