Joint letter: Europe should not rush weak solutions and miss out on real simplification of the digital framework
MedTech Europe, alongside 29 other associations, calls on Member States representatives to seize the Digital Omnibus as a unique opportunity to strengthen Europe’s technological sovereignty while ensuring a truly competitive, innovation-friendly regulatory framework.
As the EU advances its digital agenda, simplification must remain at the core of policymaking. A leaner, more coherent data framework is essential to unlocking data-driven innovation, reducing compliance burdens, and enabling companies. including those in the medical technology sector, to scale safely and effectively across Europe.
Our key recommendations:
- Promote trusted, voluntary data sharing frameworks that protect sensitive and proprietary data, rather than imposing mandatory data access requirements under the Data Act.
- Provide legal clarity under the GDPR for AI and data use, including clear guidance on legal bases, scientific research, and fraud prevention to support responsible innovation.
- Ensure full harmonisation of cybersecurity reporting obligations, including aligned timelines, thresholds, and the establishment of a single reporting interface across EU legislation.
With the European Parliament targeting February 2027 for its position, sufficient time must be granted for a thorough and balanced legislative process. Accelerated timelines risk delivering incomplete solutions.
A carefully designed Digital Omnibus is key to reinforcing Europe’s data ecosystem and innovation capacity. Read our joint industry letter below.
Posted on 12.06.2026