The EU medical device market is highly regulated by sector-specific (e.g. the EU Medical Device Regulation) and cross-sector (e.g. the EU AI Act) legislation. As a result, manufacturers need to 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 medical device design and development process from the outset. 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, this publication shows how the complex regulatory requirements can be met with CoDe. As a result, manufacturers can ensure that their products meet regulatory requirements, and that the development process is both innovative and efficient.
The VDE DGBMT recommendation is primarily aimed at manufacturers who wish to place (AI-based) medical devices on the EU market for the first time and want to gain a comprehensive insight into the relevant regulations.
