MedTech Europe’s input to the Digital Simplification Package consultation

MedTech Europe's input to the Digital Simplification Package consultation

Posted on 06.11.2025

The European Commission opened a Call for Evidence on the Digital Omnibus. The Digital Omnibus will include measures to quickly reduce the burden on businesses in the following areas:  the data acquis (Data Governance Act, Free Flow of Non-Personal Data Regulation, Open Data Directive), rules on cookies and other tracking technologies laid down by the ePrivacy Directive, cybersecurity related incident reporting obligations, the smooth application of the AI Act rules, and other aspects related to electronic identification and trust services under European Digital Identity Framework.

The European Commission's presentation of the Digital Simplification package is expected on 19 November 2025, along with the presentation of the Data Union Strategy and a proposal for the revision of the Cybersecurity Act.

MedTech Europe submitted its response to the Call for Evidence on 14 October 2025. The submission has been coordinated via the Digital Health Committee and was based on the previously published position paper on simplification of EU digital legislation.