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Monard Law

The MDR/IVDR reform proposal: simpler rules, higher expectations

On 16 December 2025, the European Commission published its proposal to amend the rules governing medical devices and in vitro diagnostic medical devices in the European Union — the MDR and IVDR — under the formal reference COM(2025)1023. The label attached to the exercise is "simplification." The substance is more ambitious than that.

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Timelex

Personal Data, Interrupted

Since the Court of Justice’s September judgment in EDPS v Single Resolution Board (C-413/23 P, ‘SRB Case’), the discussion on the notion of personal data has hardly slowed, and practitioners keep adding fresh voices on the likely consequences of the verdict. The discussion has also been enriched by proposed amendments to the GDPR and the Regulation 2018/1725 resulting from the latest Digital Omnibus proposal.

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NautaDutilh

The EU Listing Act: Amendments to the Prospectus Regulation and the Market Abuse Regulation

The European capital markets are fragmented across Member States, burdened by high access costs, and governed by a framework that places EU markets at a disadvantage compared with the United States and the United Kingdom, particularly for smaller and growth companies. The EU Listing Act was developed as part of the Capital Markets Union to address these issues.

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Timelex

Streamlining regulatory oversight through the Digital Fitness Check: why better cooperation mechanisms are necessary

Why is the Commission taking a step back to look at the digital rulebook now? Over the past decade, the European Union has built an extensive digital rulebook. From data protection and cybersecurity to online platforms, artificial intelligence and data…

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Fieldfisher

EU Environmental Omnibus: A brief look at Omnibus VIII and its proposed simplifications to key environmental obligations

2025 was an interesting year for sustainability from a legislative and policy perspective. The European Commission's (the "Commission") focus on competitiveness and simplification has led to the publication of a number of omnibus packages, proposing to simplify existing legislation across several key areas – sustainability, agriculture, digitalisation, defence and chemicals.

Lire la suiteEU Environmental Omnibus: A brief look at Omnibus VIII and its proposed simplifications to key environmental obligations
Fieldfisher

EU Environmental Omnibus: A brief look at Omnibus VIII and its proposed simplifications to key environmental obligations

2025 was an interesting year for sustainability from a legislative and policy perspective. The European Commission's (the "Commission") focus on competitiveness and simplification has led to the publication of a number of omnibus packages, proposing to simplify existing legislation across several key areas – sustainability, agriculture, digitalisation, defence and chemicals.

Lire la suiteEU Environmental Omnibus: A brief look at Omnibus VIII and its proposed simplifications to key environmental obligations
Crowell & Moring

New rules in relation to work incapacity Strengthened Return-to- Work Policy and Reintegration Trajectory 3.0: What Changes as of 1 January 2026

From 1 January 2026, new rules govern work incapacity and the reintegration of employees in Belgium. The legislative changes are part of the governmentʼs overall plan regarding the prevention and reintegration of employees with long-term work incapacity.

Lire la suiteNew rules in relation to work incapacity Strengthened Return-to- Work Policy and Reintegration Trajectory 3.0: What Changes as of 1 January 2026