Medical Device Regulation (MDR)

The Medical Device Regulation (EU) 2017/745 (MDR) is a regulation established by the European Union to govern the production, distribution, and use of medical devices within the EU market and to set standards of quality and safety for medical devices. It replaces the previous Medical Device Directive and the Active Implantable Medical Devices Directive.

The MDR provides a comprehensive framework for all stages of a medical device's lifecycle, including design, manufacture, clinical investigation, clinical evaluation, marketing, and post-market surveillance. It also describes oversight on Notified Bodies, the organizations responsible for assessing conformity before a product can be placed on the market.

One of the key aspects of the MDR is that it clarifies that software, provided it is intended for medical purposes, is classified as a medical device. Additionally, it enhances traceability by introducing a unique device identification (UDI) system and requires manufacturers to implement more robust post-market surveillance and vigilance measures.

The MDR aims to guarantee that medical devices in the EU market meet high standards of safety and quality.