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Regulatory Requirements European Commission Compliance

White & Case LLP

New EU Responsibility and Liability Landscape for Smart Medical Devices in a Global Context

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Artificial intelligence (AI) is already indispensable in the healthcare and life sciences sector. Intelligent medical devices promise nothing less than a revolution in the art of healing. With its legislative projects on AI...more

Ropes & Gray LLP

Seeing the Forest for the Trees: Further Changes to the EU Deforestation Regulation are Likely

Ropes & Gray LLP on

The EU Deforestation Regulation (EUDR) covers cattle, cocoa, coffee, oil palm, rubber, soy(a) and wood, as well as many derived products. The Regulation is currently scheduled to apply to operators and traders beginning at...more

A&O Shearman

EC adopts delegated regulation requiring a review of countries that may pose a threat to the EU financial system

A&O Shearman on

The European Commission (EC) has adopted a Delegated Regulation amending a Delegated Regulation it adopted on 10 June, to introduce a review clause requiring the EC to independently assess countries that may pose a threat to...more

Baker Botts L.L.P.

EU Foreign Subsidies Regulation & M&A: Latest Developments and Implications for Deal Strategy

Baker Botts L.L.P. on

The European Union’s Foreign Subsidies Regulation (“FSR”) has now been in force for over a year, introducing a new layer of regulatory oversight for companies engaging in M&A transactions within the EU. Designed to address...more

DLA Piper

GPAI Code of Practice – Final Version Published by European Commission

DLA Piper on

The European Commission has published the final version of a general-purpose AI (“GPAI”) Code of Practice. We took a deeper look into it and prepared a short summary to help you understand what the GPAI Code of Practice is,...more

A&O Shearman

Corrigendum to EMIR 3 clarifies AML/CFT references

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A Corrigendum to Regulation (EU) 2024/2987, referred to as the revised European Market Infrastructure Regulation (EMIR 3), has been published in the Official Journal of the European Union. This Regulation amends Regulations...more

A&O Shearman

Regulatory monitoring: EU version - June 2025

A&O Shearman on

Our monthly regulatory newsletter monitors all relevant developments regarding European regulatory law in English language....more

King & Spalding

Cyber Resilience Is Key: The Never-Ending Delays of NIS2 Implementation

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The European Union’s ("EU") NIS2 Directive (Directive (EU) 2022/2555) capitalizes on the success of its predecessor, NIS, the first horizontal minimum harmonization cyber security and resilience frameworks at the EU level....more

Mayer Brown

Country Classification, Updated FAQ and Guidance, Draft Delegated Regulation: EUDR Compliance Made Easier?

Mayer Brown on

On 22 May 2025, the European Commission (“Commission”) made public risk classification of countries under the EU Deforestation Regulation (“EUDR”)1 which assigned a low level of risk to 140 countries and high level of risk to...more

Environmental General Counsel PC

A European Perspective on Sustainability, CSRD, and the Omnibus Package: An Interview with Ferruccio Bongiorni of Studio Bongiorni

Environmental General Counsel (“EGC”) Founder and Principal Catherine W. Johnson recently interviewed Ferruccio Bongiorni, Founder and Managing Director of Studio Bongiorni located in Milan, Italy, about sustainability issues...more

Ropes & Gray LLP

A Fleet of Omnibuses and Other Takeaways from Monday’s Responsible Business Alliance Conference on the CSDDD in Brussels

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On Monday, the Responsible Business Alliance hosted a stellar event in Brussels, Driving Effective Due Diligence: Omnibus Unpacked. This waitlisted, standing room-only event – co-hosted with the European People’s Party,...more

Vinson & Elkins LLP

The EU’s Proposed Omnibus Package—Sustainability Reporting Simplified

Vinson & Elkins LLP on

The past few years have seen concerted efforts — both domestically and globally — advancing the reporting and disclosure of various climate- and sustainability-related metrics by businesses and investors. One of the most...more

A&O Shearman

EBA opinion on EC's partial rejection of RTS on information required in application for authorisation of ARTs

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The European Banking Authority (EBA) has published an opinion (dated 25 February) on the European Commission's (EC's) amendments relating to the final draft regulatory technical standards (RTS) on the information to be...more

King & Spalding

EU & UK AI Round-up

King & Spalding on

The first EU & UK AI Round-up, published on 15 January 2025, discussed the important regulatory updates affecting the AI ecosystem in both the EU and the UK that occurred towards the end of 2024. Notably since that update,...more

Skadden, Arps, Slate, Meagher & Flom LLP

European Commission Publishes ESG Reporting Omnibus Package

On 26 February 2025, the European Commission (the EC) adopted a new package of proposals aimed at simplifying the EU’s ESG reporting and compliance requirements. The EC published two separate proposals for directives to make...more

K&L Gates LLP

Europe: ESMA and National Regulators Launch Coordinated Review of Fund Manager Compliance and Internal Audit Functions

K&L Gates LLP on

On 14 February 2025, the EU’s securities and markets regulator, the European Securities and Markets Authority (ESMA), launched a Common Supervisory Action (CSA) with EU Member State National Competent Authorities (NCAs), in...more

A&O Shearman

European Commission clarifies key concepts of the Data Act in updated FAQs

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On February 3 2025, the European Commission published an updated version of the Frequently Asked Questions (FAQs) about the Regulation (EU) 2023/2854 on harmonised rules on fair access to and use of data (Data Act). Key...more

A&O Shearman

European Commission draft guidelines on AI system definition under EU AI Act

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The European Commission (EC) has published draft guidelines on the definition of an AI system to explain the practical application of the legal concept, as anchored in the EU AI Act. The EC aims to assist providers and other...more

Goodwin

Regulatory Updates on Samsung’s Denosumab Biosimilars

Goodwin on

On February 13, 2025, the FDA approved Samsung Bioepis Co., Ltd.’s denosumab biosimilars, OSPOMYV™ (denosumab-dssb; 60 mg pre-filled syringe) and XBRYK™ (denosumab-dssb; 120 mg vial), referencing Amgen’s PROLIA® and XGEVA®,...more

A&O Shearman

European Commission rejects draft technical standards on sub-contracting ICT services under Digital Operational Resilience Act

A&O Shearman on

The European Commission has published a letter (dated 21 January 2025) addressed to the Joint Committee of the European Supervisory Authorities (ESAs) rejecting certain draft regulatory technical standards (RTS) the ESAs...more

A&O Shearman

Zooming in on AI - #14: Enforcement of the AI Act

A&O Shearman on

The European Union Artificial Intelligence Act (AI Act) entered into force on 1 August 2024. The AI Act establishes a risk-based approach to AI, prohibiting certain practices that are deemed unacceptable, such as social...more

A&O Shearman

European Commission adopts Delegated Regulation on over-the-counter derivatives identifying reference data under EU Markets in...

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The European Commission has adopted a Delegated Regulation supplementing the EU Markets in Financial Instruments Regulation on OTC derivatives identifying reference data to be used for the purposes of the transparency...more

HaystackID

AI Under Scrutiny: Europe’s Landmark AI Act Begins Enforcement

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The European Union’s AI Act is now in effect. Officially entering into force on August 1, 2024, the regulation has begun reshaping the artificial intelligence landscape across Europe. While some of its key prohibitions will...more

Proskauer - Regulatory & Compliance

European Commission’s Competitiveness Compass – is it the roadmap for simplification of EU sustainability regulations?

On 29 January 2025, the European Commission published a communication on its Competitiveness Compass for the EU (COM(2025) 30). The Competitiveness Compass outlines the European Commission’s proposed initiatives for the next...more

Morrison & Foerster LLP

Current developments in ESG obligations in the EU: Omnibus Regulation and EU Deforestation Regulation

In the EU, the new year brings on the one hand hope for relief regarding ESG reporting and disclosure obligations (I. below). On the other hand, the EU Deforestation Regulation (EUDR) will create new burdens for many...more

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