Digital Omnibus: MedTech Europe calls for real simplification, coherence and predictable timelines

MedTech Europe acknowledges the publication of the Digital Omnibus package by the European Commission and calls on policymakers to ensure this initiative truly simplifies and clarifies digital regulations for Europe’s medical technology sector.

The Digital Omnibus seeks to streamline the EU’s complex digital legislative framework, addressing concerns about overlapping and fragmented compliance requirements. For the medical technology sector, including connected devices, diagnostic software, and AI-driven solutions, these challenges are significant. Yet, innovation and patient access to cutting-edge solutions are hindered by unclear, fragmented or duplicative rules layered over existing sectoral legislation.

MedTech Europe welcomes the European Commission’s intent to simplify digital legislation but urges for the package to go further to safeguard Europe’s leadership in medical innovation.

Read our full statement below.