Implementation, Simplification & Better Regulation

Digital Omnibus

Planned for 19 November 2025.

The Commission will table a simplification package to cut compliance costs in the digital acquis while preserving protections. It will rationalise data rules (i.e. DGA, Free Flow of Non-Personal Data, Open Data), modernise cookie/tracking provisions to curb consent fatigue, and streamline overlapping cybersecurity incident reporting, with targeted adjustments to ensure predictable application of the AI Act. It will also clarify obligations under the European Digital Identity framework and align with the forthcoming Business Wallet, applying ‘one-in, one-out’. A Digital Fitness Check will assess cumulative effects and cross-border fragmentation.

Omnibus IV Package

The Commission will fast-track simplification by empowering common technical specifications when harmonised standards lag, and by digitalising compliance so firms can demonstrate conformity faster and paper-free. The package also extends existing SME mitigating measures to small mid-caps and removes redundant paper requirements in product laws, easing conformity assessment and cutting reporting overlaps. Together with the Single Market Strategy, it targets quicker time-to-market, legal certainty and lower costs while maintaining high safety and consumer protection. Delivery will be tied to measurable burden-reduction targets and periodic scorecards so businesses see real, near-term gains in every Member State.

Better Regulation Communication

Planned for Q2 2026.

Just like the EU’s rules, its better regulation framework must be simplified to enable a simpler and faster Europe. The Commission will therefore apply a more rigorous and structured application of the proportionality principle in better regulation and put forward a communication to that effect in the first half of 2026.

Commissioner for Implementation and Simplification

Announced on 11 February 2025.

The Commissioner will lead a whole-of-Commission drive to make EU rules simpler, faster and better enforced. The agenda prioritises early implementation strategies with Member States, hands-on “reality checks” with practitioners, and twice-yearly implementation dialogues in every portfolio feeding annual progress reports and resolute enforcement against fragmentation and gold-plating. New quantified targets will cut recurring administrative costs by at least 25% (35% for SMEs), underpinned by omnibus simplification packages, streamlined permitting, and digital-by-default delivery. A rolling stress-test of the entire acquis will consolidate and clarify rules; reinforced SME/competitiveness checks, proportionate use of delegated/implementing acts, and digital tools (such as a European Business Wallet and once-only interoperability) will lower costs and speed compliance.

Defence Readiness Omnibus

The Commission will table a defence-sector omnibus to cut red tape and speed delivery across the European defence industrial base. Measures include cross-certification and mutual recognition of testing, fast-tracked construction and environmental permits, secure handling of confidential data, and easier access to finance, including ESG-sensitive capital. It will streamline EU defence programmes, simplify co-funding, and prepare revisions of defence procurement and intra-EU transfer rules, followed by a faster EDF process. The package also supports security-of-supply and readiness, and leverages Ukraine’s innovative defence ecosystem within Team Europe instruments. Together, it builds a scalable EU-wide market for defence equipment.

EU Treaty Change

Announced on 18 July 2024.

To equip a larger, more contested Union, the Commission will pursue institutional reforms, up to targeted Treaty changes where they clearly improve capacity to act and democratic accountability. It couples faster, simpler law-making with rigorous implementation: stress-testing the acquis, reducing administrative burdens, and renewing an interinstitutional pact on better lawmaking. Each Commissioner will hold biannual implementation dialogues and publish annual progress reports, while enforcement against Single Market fragmentation is stepped up. The objective is a Union that legislates less and delivers more so Europe can decide and act at the speed today’s challenges demand.

Fitness Check on the Legislative Acquis in the Digital Policy Area

Planned for Q4 2025.

The Commission will stress-test the EU’s digital rulebook to cut costs, remove overlaps and improve coherence, with results due in Q4 2025. It will assess cumulative burdens on businesses across data legislation, cookies and tracking, cybersecurity incident reporting, AI Act implementation, and the European Digital Identity framework, feeding simplification proposals. The exercise will complement the Digital Omnibus and examine cross-border fragmentation and costs, without lowering protections. Each Commissioner will review laws in remit under the steer of the Commissioner for Implementation and Simplification, drawing on “reality checks” with practitioners to ground changes in practice.

Infringement Procedures

Announced on 11 February 2025.

The Commission will act decisively when cooperation fails to secure compliance. It will prioritise breaches with the greatest impact on citizens, businesses and Single Market integrity, combat unlawful gold-plating, and use pre-infringement dialogue to deliver swift fixes (75% success in 2024). Where necessary, it will open formal cases—currently about 1,500 —and refer them to the Court of Justice faster, seeking financial sanctions under Articles 260(2) and 260(3) TFEU. In 2023–24, 134 cases were referred, with sanctions requested in 55. Annual progress reports will track enforcement, while sectoral monitoring tools identify and remedy fragmentation early and communicate reasons for action clearly.

Interinstitutional Agreement on Better Lawmaking

Planned for this term.

The Commission will seek a renewed agreement with Parliament and Council to embed simplification and implementation across the full legislative cycle. It will align subsidiarity/proportionality checks, apply a shared methodology to estimate the costs of significant amendments, and integrate SME/competitiveness tests up front. Co-legislators will commit to fast-tracking simplification packages, limiting gold-plating and streamlining empowerments for delegated/implementing acts. Annual progress reporting will create accountability on enforcement and burden-reduction targets, while “digital-by-default/once-only” delivery and interoperability requirements are designed in from the start. Together, the institutions will stress-test the acquis to cut administrative costs without lowering standards.

Legislative Implementation Strategies

Announced on 11 February 2025.

For every major EU law, the Commission will prepare a structured implementation strategy that maps legal, administrative and practical challenges, sets timelines, and defines targeted support. These strategies will use explanatory templates and national transposition roadmaps, track progress, and flag “gold plating” that fragments the Single Market. Delivery will be backed by expert-group peer support and EU agencies, plus investments in administrative capacity, digital tools and data (e.g. TSI, ComPAct, IMI, Single Digital Gateway). The Commission will hold twice-yearly implementation dialogues with stakeholders and publish annual progress reports to surface hurdles and simplification opportunities. Hands-on “reality checks” with practitioners will verify costs and fix bottlenecks early; where dialogue fails, swift infringement action will follow.

Medical Omnibus

Planned for 2026.

The Commission will be ready to propose a targeted legislative package to simplify EU rules for medical devices and in-vitro diagnostics while safeguarding patient safety and public health, including in health emergencies. This follows a targeted evaluation of the MDR/IVDR to address identified bottlenecks and facilitate firms’ operations across the Single Market. Complementary enablers, such as the European Business Wallet, will reduce administrative barriers by enabling secure, verified data and credential sharing for compliance processes. The initiative aligns with the Life Sciences Strategy’s drive to streamline regulation and speed market access for innovation, especially for startups and SMEs.

Reality Checks

Announced on 11 February 2025.

Reality Checks are hands-on diagnostics that bring Commission services to practitioners to test whether EU rules work in real life. Through targeted technical exchanges, teams identify hurdles in authorisations, permitting, control and compliance, capture good practices, and map where national transposition or “gold-plating” adds cost or fragmentation. Findings verify the assumptions behind legislation, quantify burdens and expected savings, and assess if planned simplifications are realistic. Results feed directly into evaluations and fitness checks, the gradual stress-test of the acquis, and the design of future simplification packages, ensuring evidence-based fixes and quicker, cheaper compliance without lowering standards.

Reporting Burden Goal

Announced on 11 February 2025.

The Commission will deliver quantified, mandate-wide cuts to red tape: at least 25% for all firms and 35% for SMEs, applied to all administrative costs, not only reporting. Using Eurostat’s €150 billion estimate of recurring administrative costs (2022), this implies €37.5 billion in annual savings by end-mandate. Progress will be tracked in yearly enforcement and implementation reports, with dedicated SME measures and avoidance of national “gold-plating”. The drive complements “one-in, one-out” and will be executed via prioritised simplification packages and Omnibus proposals, while co-legislators preserve savings in negotiations and Member States streamline transposition and application.

Review of National and European Agencies

Planned for Q1 2026.

The Commission will audit mandates, governance and resources of Single Market authorities to eliminate overlap, gaps and conflicting procedures. The review will benchmark performance, map workflows, and propose consolidation, clarified competences, interoperable IT, joint inspections and mutual recognition of decisions. It will align agency tasks with the ‘Terrible Ten’ barrier agenda and forthcoming Omnibus simplifications, reducing compliance friction for SMEs and small mid-caps. Deliverables include a reform blueprint and actions to streamline supervision in priority sectors. Expected outcomes: accountability, faster enforcement, consistent interpretation of EU law, lower costs, and improved consumer protection.

SME & Competitiveness Checks

Announced on 11 February 2025.

Will be mandatory for proposals with business impacts, combining a reinforced SME test with a sector-focused competitiveness lens. The check assesses four dimensions (i.e. cost/price effects, international competitiveness, innovation capacity, and specific SME impacts) and examines cumulative burdens across value chains. Findings will shape mitigation (e.g. lighter regimes, phased timing, digital-by-default delivery) and be transparently presented in impact assessments, with stronger analysis of indirect effects on SMEs. Fitness checks will also report on efficiency for SMEs. Results feed progress reports and a stress-test of the acquis, ensuring no new Single Market barriers and aligning rules with Europe’s overall growth agenda.