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European Union › Regulatory Standards › Regulatory Requirements

The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of... more +
The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of WWII. The EU maintains a common currency as well as several intranational institutions, including the European Parliament and the European Commission. less -
A&O Shearman

EBA consults on draft RTS and guidelines for third country branches under CRD IV

A&O Shearman on

The European Banking Authority (EBA) has published three consultation papers under Directive 2013/36 (CRD IV), as amended by Directive 2024/169 (CRD VI), relating to the regulatory requirements for third country branches...more

A&O Shearman

EBA review of RTS under PAD

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The European Banking Authority (EBA) has published a report and accompanying press release, on its review of the regulatory technical standards (RTS) under the Payment Accounts Directive concerning standardised terminology...more

Orrick, Herrington & Sutcliffe LLP

Navigating the Accessibility Improvement Act: Germany's Implementation of the European Accessibility Act

Orrick, Herrington & Sutcliffe LLP on

On June 28, 2025 the Accessibility Improvement Act (Barrierefreiheitsstärkungsgesetz ("BFSG")), Germany's implementing act of the European Accessibility Act ("EAA"), will come into force, imposing a whole range of new...more

A&O Shearman

EC adopts technical standards for the development of consolidated tapes

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The European Commission (EC) has adopted a suite of technical standards for the development of consolidated tapes. The creation of consolidated tapes and the removal of obstacles to the development of consolidated tapes, were...more

A&O Shearman

Further suite of technical standards supplementing MiCAR published in the OJ

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Three Commission Delegated Regulations supplementing Regulation (EU) 2023/1114 (the EU Markets in Crypto Assets Regulation) (MiCAR) have been published in the Official Journal of the European Union, namely: - Commission...more

Hogan Lovells

The EBA’s draft regulatory technical standard on customer due diligence - What should firms be worried about?

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The European Banking Authority consultation on customer due diligence under the EU’s 6th money laundering package closes on 06 June, 2025, with the EBA due to submit its findings to the European Commission’s call for evidence...more

A&O Shearman

ESMA consultation on transparency and integrity of ESG rating activities

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The European Securities and Markets Authority (ESMA) has published a consultation paper on draft regulatory technical standards (RTS) on the transparency and integrity of environmental, social and governance (ESG) rating...more

Goodwin

Liquidity Management Under AIFMD2: Near-Final RTS for Open-Ended Funds

Goodwin on

Following our September 2024 Alert “Liquidity Management Under AIFMD2: RTS for Open-Ended Funds,” the European Securities and Markets Authority (ESMA) has now published Final Reports for “Guidelines on LMTs of UCITS and...more

A&O Shearman

ESMA publishes final draft RTS and guidelines on Liquidity Management Tools for Funds

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The European Securities and Markets Authority (ESMA) has published its final draft regulatory technical standards (RTS) relating to liquidity management tools (LMTs) under the Alternative Investment Fund Managers Directive...more

Katten Muchin Rosenman LLP

DORA Compliance: Navigating the Latest Developments

Katten Muchin Rosenman LLP on

On 24 March 2025, the following two developments relating to the implementation of the EU Digital Operational Resilience Act (DORA) took place...more

A&O Shearman

Further suite of technical standards supplementing MiCAR published in the OJ

A&O Shearman on

Six Commission Delegated Regulations supplementing Regulation 2023/114 (the EU Markets in Crypto Assets Regulation) (MiCAR) have been published in the Official Journal of the European Union (OJ), namely: Commission...more

A&O Shearman

RTS on criteria for the composition of joint examination teams under EU DORA published in OJ

A&O Shearman on

Commission Delegated Regulation 2025/420 has been published in the Official Journal of the EU. This Delegated Regulation supplements Regulation 2022/2554 on digital operational resilience for the financial sector (DORA)...more

A&O Shearman

European Commission adopts RTS on the elements to assess when subcontracting certain ICT services under DORA

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The European Commission has adopted a Delegated Regulation supplementing Regulation 2022/2554 on digital operational resilience for the financial sector (DORA) with regard to regulatory technical standards specifying the...more

A&O Shearman

Suite of regulatory technical standards supplementing MiCAR published in OJ

A&O Shearman on

Four Commission Delegated Regulations supplementing Regulation 2023/1114 (MiCAR) have been published in the Official Journal of the EU, namely: - Commission Delegated Regulation - 2025/415 supplementing the EU Markets in...more

Skadden, Arps, Slate, Meagher & Flom LLP

The Standard Formula: Encyclopaedia of Prudential Solvency – Chapter 1: The IAIS and the ICS

Skadden, Arps, Slate, Meagher & Flom LLP on

Established in 1994, the International Association of Insurance Supervisors (IAIS) is a voluntary membership organisation comprising insurance regulatory authorities, central banks, ministries of finance, and other...more

A&O Shearman

EU MiCAR technical standards published

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Two delegated acts were published in the Official Journal of the European Union (OJ) in respect of the EU MiCAR. - Commission Delegated Regulation (EU) 2025/303, which comprises regulatory technical standards specifying the...more

A&O Shearman

European Central Bank Publishes Paper on TIBER-EU and EU Digital Operational Resilience Act Requirements

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The European Central Bank has published a paper outlining how the European framework for threat intelligence-based ethical red teaming, the TIBER-EU framework, can help competent authorities and financial entities fulfil...more

McDermott Will & Emery

The Impact of the New EU AI Act on the Medtech and Life Sciences Sector

McDermott Will & Emery on

As technology continues to advance almost every aspect of healthcare, so the use of AI has become an increasing focus for developers and the regulators who are racing to keep pace with rapid advancements in technology. ...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

European Union Digital Services Act: New Regulations Apply

Ogletree, Deakins, Nash, Smoak & Stewart,... on

The European Union Digital Services Act (DSA) now applies to all digital “intermediary services” that provide users with access to online goods, services, and content. The DSA took effect on November 16, 2022, and regulates a...more

King & Spalding

FDA Aligns U.S. Medical Device Quality System Regulation with International Standards

King & Spalding on

On February 2, 2024, the U.S. Food and Drug Administration (FDA) published a final rule amending the device good manufacturing practice (GMP) requirements of the Quality System Regulation (QSR) and harmonizing them with...more

Hogan Lovells

New medical device regulation in Spain opened for public consultation

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Spain’s Ministry of Health initiated proceedings for approval of the new regulation on medical devices with a call for a prior public consultation to receive contributions from interested parties....more

Mayer Brown

Legal Update: regulatory technical standards on homogeneity for STS transactions published in official journal

Mayer Brown on

The EU has, on 6 November 2019, published in the Official Journal a delegated regulation (the “Delegated Regulation”) supplementing the EU Securitisation Regulation (the “Securitisation Regulation”) with regard to regulatory...more

Hogan Lovells

European Commission provides clarification regarding the implementation of the Clinical Trials Regulation

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The European Commission has published an updated Questions and Answers document concerning the Clinical Trials Regulation (EU) 536/2014. The document provides clarification regarding the implementation of the rules governing...more

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