Regulation (EU) 2017/745 on medical devices (Medical Devices Regulation)

Overview

The Medical Devices Regulation (MDR) establishes a robust regulatory framework for medical devices in the EU. It introduces stricter requirements for clinical evidence, including clinical investigations for implantable and class III devices, enhances the role of notified bodies with stricter designation criteria, requires unique device identification (UDI), establishes the European database on medical devices (EUDAMED), and imposes new obligations on manufacturers, importers, and distributors. The regulation introduces new classification rules, including for software as a medical device. Regulation (EU) 2017/745 applies from 26 May 2021 with transitional periods.

This eu regulation (32017R0745) 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: 32017R0745

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

Key Provisions

Regulation (EU) 2017/745 on medical devices (Medical Devices Regulation) 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.