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Regulatory Requirements European Union Regulatory Standards

A&O Shearman

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

A&O Shearman on

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

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

Hogan Lovells on

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

Hogan Lovells on

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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