MD CoDe – Compliance by Design as a key concept for meeting the European regulatory requirements for medical devices

Abstract

The EU market for medical devices is highly regulated by sector-specific (e.g., EU Medical Device Regulation) and cross-sectoral (e.g., EU AI Act) legislation. As a result, manufacturers must invest significant human and time resources in regulatory compliance before placing their products on the EU market. This problem can be solved by adopting a “compliance by design” (CoDe) approach, which integrates regulatory requirements into the design and development process of the medical device right from the start. In addition to cost efficiency, key benefits of CoDe include faster time-to-market, improved product quality, and regulatory flexibility. Based on a use case, we show in this publication how the complex regulatory requirements can be met by CoDe. This enables manufacturers to ensure that their products comply with regulatory requirements and that the development process is innovative and efficient at the same time. The ThrombUS+ use case is primarily described in Chapter 3. Hereby, the reader does not only get deep theoretical insights into regulatory topics but also learns to put these in the context of a concrete medical device. In Chapters 4 and 5 the EU regulatory framework for medical devices is summarized and the steps towards placing a medical device on the market are discussed in detail. Chapter 6 discusses the obligations of Notified Bodies in the pre- and post-market phases, as they play a key role in the EU market access of medical devices. Finally, Chapters 7 and 8 show the identification of further legislation that needs to be considered today and in the future with respect to the medical device being developed in the ThrombUS+ project.