News & Analysis as of

Regulatory Requirements European Union Life Sciences

McDermott Will & Emery

Private Markets Update | Summer 2024

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The Private Markets Update highlights key developments emerging from private markets across Europe, the UK and the United States, exploring the cross-border issues that matter to investors and sponsors in alternative assets. ...more

McDermott Will & Emery

International News: Spotlight on Innovation - Issue 60

McDermott Will & Emery on

Innovation fuels business growth and ushers in success, yet it brings its own set of challenges. In our latest issue, we explore innovative products and processes including: - The EU’s new Unified Patent Court...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

Akin Gump Strauss Hauer & Feld LLP

Akin Intelligence - March 2024

Welcome to the March edition of Akin Intelligence. This month, the EU AI Act was approved by the European Parliament, moving one step closer to becoming the first major AI law. In the U.S., the DOJ brought criminal charges...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q4 2023 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

A&O Shearman

Commission proposal for a new European legal framework for GMOs

A&O Shearman on

In its two Confédération Paysanne decisions (cases C-528/161 and C-688/21), the Court of Justice of the European Union limited the exclusion of plants and products obtained by new genomic techniques (NGTs) from the...more

Latham & Watkins LLP

EU MDR Transitional Provisions Officially Extended

Latham & Watkins LLP on

The revised provisions provide medical device and in-vitro diagnostics manufacturers with additional time to bring their product into compliance with the new EU Regulations, subject to a number of conditions. On March 20,...more

Hogan Lovells

MDCG guidance for consultations of authorities on devices incorporating a medicinal product

Hogan Lovells on

On 10 June 2020, the MDCG issued guidance MDCG 2020-12 on the transitional provisions concerning the consultation of authorities regarding devices incorporating a substance.....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

Hogan Lovells

European Commission publishes new documents regarding the Clinical Trials Regulation

Hogan Lovells on

Shortly after updating the related draft Questions and Answers document, the European Commission has published two new documents concerning the Clinical Trials Regulation (EU) 536/2014. The first document is an informed...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

Orrick, Herrington & Sutcliffe LLP

More Affordable and Innovative Medicines and Treatments in Europe – Has the Competition Enforcement Met the 2009 Objective?

A decade ago, the European Commission conducted a thorough sectoral inquiry into the European pharmaceutical sector that identified antitrust shortcomings impeding access to more affordable and innovative medicines and...more

Hogan Lovells

Post-registration changes in case of no-deal Brexit

Hogan Lovells on

On 25 February 2019[1], the President of the Polish Office for the Registration of Medicinal Products, Medical Devices, and Biocidal Products issued a communique concerning the necessary post-registration changes in the event...more

Hogan Lovells

EU: New developments in the SPC manufacturing waiver legislative process

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Following the European Commission’s draft proposal for implementing the so-called SPC manufacturing waiver the Committee on Legal Affairs of the European Parliament published a draft report on presenting its suggested...more

Hogan Lovells

Regulatory Insights for Life Sciences and Health Care Investments: Value-based purchasing

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Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product’s success or failure could cost you millions of dollars....more

Hogan Lovells

The European Parliament adopted a report on the Commission Proposal for a Regulation on Health Technology Assessment

Hogan Lovells on

On 4 October 2018, the European Parliament adopted its Report on the Commission Proposal for a Regulation on Health Technology Assessment (HTA)....more

Hogan Lovells

Brexit, medical devices and transfer of notified bodies

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In the recently published White Paper governing the future relationship between the United Kingdom and the European Union, the UK proposes a "common rulebook" between the parties in relation to goods....more

Hogan Lovells

UK Government Publishes Guidance for Life Sciences Companies on Brexit Transition

Hogan Lovells on

The UK Government has published guidance for life sciences companies on the Brexit implementation period, which is intended to take effect from 30 March 2019 to the end of 2020. ...more

Hogan Lovells

MDR and IVDR: MedTech Europe calls for an extension of the transitional provisions

Hogan Lovells on

On 27 July 2018, the European trade association representing the medical technology industries, MedTech Europe, issued a position paper in which the association requests the European Commission, the European Parliament and...more

Hogan Lovells

Digital health: Understanding the new responsibilities facing life sciences companies related to collecting and processing...

Hogan Lovells on

In May 2018, the General Data Protection Regulation (GDPR) entered into effect in EU member states, replacing a longstanding and less rigorous data and e-privacy directive. ...more

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