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Welcome to the fourth edition of the MHC Mid-year Digital Health Review, your guide to the ever-evolving landscape of digital health regulation in the EU.

As EU policymakers strive to foster innovation while ensuring high levels of patient safety, data privacy and cybersecurity, and health systems continue to invest in technologies that will allow them to provide care to growing populations of patients with complex and changing needs, we cover various key legal developments from the last 6 months:

  • After a long running saga, and in order to avoid the possible removal of essential medical devices from the EU market, an amendment to the Medical Device Regulation (MDR) extending the Medical Device Directive (MDD) transition timelines has now been adopted. We provide the background to this development and set out the key take aways for businesses
  • We take a closer look at the planned changes to EU product liability legislation that are set to have a significant impact on software developers including digital health stakeholders
  • Further analysis for stakeholders in the sector is provided in our article providing an overview of some key considerations when seeking to set up decentralised trials in the EU
  • We provide an overview and some updates on the status of the EU AI Act and its expected impact on the regulation of certain digital health products
  • We also highlight some of the intellectual property risks involved in packaging software and hardware products together as part of a digital health offering

The MHC Digital Health Review serves as a trusted resource for keeping up with the latest trends, regulatory updates, and emerging policies in EU digital health. Whether you are a healthcare professional, a technology developer, an investor, or a policymaker, we aim to provide you with the actionable insights necessary to navigate regulatory challenges and seize the opportunities in this rapidly evolving sector. We hope you enjoy this edition of the Review.

Download your copy of the Review via the link below in Related Downloads.

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