MD CoDe Compliance by Design for Medical Devices

This technical report outlines the concept of Compliance by Design (CoDe) in the context of meeting European regulatory requirements for medical devices. It emphasizes the importance of integrating regulatory considerations into the design and development process from the outset to enhance efficiency and compliance. The report discusses the complex regulatory landscape that manufacturers face, including sector-specific and cross-sectoral legislation. It presents a use case based on the ThrombUS+ project, demonstrating how CoDe can facilitate compliance while promoting innovative product development. The document details the steps necessary for placing a medical device on the EU market, including the establishment of a quality management system, technical documentation preparation, and risk management. Additionally, it covers the obligations of Notified Bodies during the pre- and post-market phases and identifies relevant legislation that manufacturers must consider both now and in the future. The report serves as a comprehensive guide for stakeholders involved in medical device development and regulatory compliance.