EU Medical Device Regulation 2017/745 and Software Compliance

This whitepaper discusses the implications of the EU Medical Device Regulation 2017/745 (MDR) for medical software and its users. It outlines the transition from the previous Medical Devices Directive 93/42/EEC to the new regulation, which aims to enhance patient safety and modernize the regulatory framework for medical devices, particularly software classified as medical devices (MDSW). The document details the new responsibilities for healthcare organizations, including the requirements for pre- and post-sale activities, risk classification, and compliance with safety and performance standards. It emphasizes the necessity for manufacturers to define intended use, conduct risk analysis, and obtain CE marking through a Notified Body for higher-risk classifications. The paper also addresses the responsibilities of users in managing software compliance, including the evaluation of software modifications and adherence to detailed instructions for use. Overall, the whitepaper serves as a guide for navigating the regulatory landscape introduced by the MDR, focusing on software as a medical device.