MedTech Europe’s response to the public consultation on the Digital Omnibus

MedTech Europe welcomes the opportunity to comment on the Digital Simplification Package (Digital Omnibus), a timely initiative aimed at improving regulatory coherence and strengthening Europe’s digital competitiveness. Representing the medical technology sector, our members develop innovative medical devices, connected solutions, diagnostic software, and AI‑enabled technologies within a robust regulatory framework that safeguards patient safety, quality, and trust.

Digital medical technologies are increasingly central to improving healthcare outcomes, enabling earlier diagnosis, more personalised care, and better clinical decision‑making. Ensuring that horizontal digital legislation is simplified and aligned is therefore essential—not only for compliance, but to allow innovation to translate efficiently into safe and effective technologies for patients and health systems.

MedTech Europe supports the ambition to streamline EU digital legislation and emphasises the need for concrete measures that deliver real improvements in legal clarity, operational certainty, and regulatory alignment. Read our full response below.