In 2024, the regulatory environment in the EU regarding data became more complex, as three horizontal digital EU Regulations and Directives came into force. In August 2024, our Founder & Executive Board Member Jörg Dogwiler assessed the impact of these intertwined regulations and directives on medical device manufacturers in a trio of downloadable articles.

The Data Act (Regulation (EU) 2023/2854) was one of the covered regulations, and 18 months on – in our updated article, Jörg re-looks at the Act’s relevance for manufacturers of medical devices in the EU and Switzerland.

Available to download below, the article outlines a refreshed, up-to-date overview of the legislation including a summary of its benefits, the types of medical device data covered under the Act, relevant stakeholders affected, and the implications for device design and data access. The legal framework’s interaction with the EU MDR and IVDR is also touched on, as well as some practical advice on preparing for compliance.

Access the full article within the document viewer or at the download button, and should you have a data challenge related to your medical device, feel free to get in touch with our team of experts.