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European Union › Medical Devices

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

AI in healthcare: Legal and ethical considerations in this new frontier

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Can human beings cure all diseases in our lifetime? For centuries, humanity has strived to cure diseases. With the advent of Artificial Intelligence (AI), the dream of a disease-free world seems more attainable than ever...more

Jones Day

Product Regulation and Metrology Bill Receives Royal Assent

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The Product Regulation and Metrology Act 2025 reforms the UK's post-Brexit product safety, metrology, and consumer protection frameworks....more

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

A&O Shearman

Federal Circuit Invalidates Patent For Angioplasty Catheter Based On Applicant Admitted Prior Art

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The Federal Circuit recently issued a precedential decision in Shockwave Med., Inc. v. Cardiovascular Sys., Inc. (CSI), affirming-in-part and reversing-in-part the Patent Trial and Appeal Board’s (PTAB) decision, and...more

Hogan Lovells

Life Sciences Law Update Key developments for pharma and medical device companies in EU and Germany, France, UK, Italy and Spain...

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Pharma: Reform of the EU Pharmaceutical Legislation; German Medical Research Act enacted fostering R&D also including confidentiality of drug prices; France adopts standard CTA clauses; UK easing clinical trials; Devices:...more

Hogan Lovells

China announces new restrictions on the participation of certain EU-origin medical devices in government procurement activities

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China imposed new restrictions on the eligibility of certain medical devices originating from the EU in government procurement activities effective July 6, 2025. New restrictions do not apply to EU companies participating in...more

A&O Shearman

A new European strategy to foster life sciences innovation and market access

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On July 2, 2025, the European Commission released its communication “Choose Europe for life sciences. A strategy to position the EU as the world’s most attractive place for life sciences by 2030” (the Strategy). ...more

Hogan Lovells

EU adopts restrictions on access of Chinese companies to EU public procurement for medical devices

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Following approval by EU Member States in the Trade Barriers Committee, on 19 June 2025, the European Commission adopted the first measure (Implementing regulation - EU - 2025/1197 - EN - EUR-Lex) under the International...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Third Quarter of 2025 and Beyond

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

White & Case LLP

EU imposes first International Procurement Instrument measure restricting Chinese access to medical devices procurement

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Adopted in 2022, the IPI allows the Commission to investigate alleged non-EU country measures or practices against EU economic operators that limit access to the public procurement and concession markets of non-EU countries....more

A&O Shearman

EU restricts Chinese access to public procurement of medical devices

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Last Friday, the European Commission announced its first International Procurement Instrument (IPI) measure, excluding “economic operators” from China from participation in EU public procurement procedures for medical devices...more

Knobbe Martens

TELA Bio Launches OviTex Inguinal Reinforced Tissue Matrix in Europe

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TELA Bio—which was founded in 2012 and is headquartered in Pennsylvania—is a medical device company that specializes in providing soft-tissue surgical products. According to TELA Bio, its soft-tissue reconstruction solutions...more

King & Spalding

EUROPE – European Commission Excludes Chinese Medical Device Manufacturers from EU Public Procurement Contracts

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On June 19, 2025, the European Commission (“EU Commission”) adopted Regulation 2025/1197 imposing restrictive measures on Chinese medical devices in its first use of the European Union’s International Procurement Instrument...more

King & Spalding

EUROPE - Navigating the Interplay Between EU AI Act and Medical Device Regulations: Strategic Update for the Healthcare Sectors

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Already highly regulated with a risk-based approach at their core, AI-powered medical devices and in vitro diagnostic medical devices face new regulatory constraints stemming from the EU AI Act, a horizontal legal instrument...more

Hogan Lovells

MDCG published new guidance on the interplay between the MDR & IVDR and the AI Act

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On 19 June 2025, the Medical Device Coordination Group (“MDCG”) published new guidance on the interplay between the MDR & IVDR and the AI Act (MDCG 2025-6). The document provides a first set of answers to the most frequently...more

Hogan Lovells

New MDCG guidance clarifies rules for medical device software available on online platforms

Hogan Lovells on

The Medical Device Coordination Group (“MDCG”) has issued guidance on the safe making available of medical device software (“MDSW”) apps on online platforms (MDCG 2025-4). MDCG 2025-4 outlines the regulatory roles of online...more

Knobbe Martens

European Union Votes to Curb China’s Access to Medical Device Market

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The European Union has “agreed overwhelmingly” to limit Chinese medical device manufacturers’ access to public procurement contracts in Europe, Bloomberg reports. On Monday June 2, 2025, European Union (EU) countries...more

McGuireWoods LLP

Healthcare & Life Sciences Private Equity Deal Tracker: Great Point Acquires Eutecma

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Great Point Partners (GPP) has announced the acquisition of a majority stake in Eutecma. Eutecma, founded in 2008 and based in Germany, is a developer of temperature-controlled packaging solutions for pharmaceutical cold...more

Jones Day

EU Geopolitical Risk Update - Key Policy & Regulatory Developments No. 121

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This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia’s war against Ukraine, health threats, and cyber threats. It does not...more

Hogan Lovells

AI Summit panelists mull complexities of EU’s AI Act, global compliance considerations

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Hogan Lovells and the AI Health Care Coalition recently hosted their fourth annual AI Health Law & Policy Summit, where thought leaders and policymakers gathered to discuss a variety of topics including evolving regulatory...more

White & Case LLP

AI’s Expanded Role in the Life Sciences Regulatory Review Process: Key Developments in U.S. and EU

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Overview - - The U.S. Food and Drug Administration (FDA) announced that it aims to increase the agency’s use of artificial intelligence (AI) across its centers to accelerate scientific reviews by June 30, 2025. - The...more

Ropes & Gray LLP

Regulatory Landscape for AI-enabled MedTech in APAC

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Regulation of artificial intelligence (AI) in Asia Pacific remains nascent, mostly governed by existing regulatory frameworks designed for other technologies and products. It’s a work in progress. AI techniques – machine...more

Knobbe Martens

Zydus Lifesciences in Discussions to Acquire Majority Stake in Amplitude Surgical for €256.8m ($277.4m)

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Zydus Lifesciences Limited announced on March 11, 2025, that it entered into an agreement to acquire a majority stake in Amplitude Surgical. Reports state that Zydus Lifesciences has a tender offer agreement with PAI...more

Jones Day

EU Geopolitical Risk Update - Key Policy & Regulatory Developments No. 120

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This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia’s war against Ukraine, health threats, and cyber threats. It does not...more

A&O Shearman

New CJEU ruling on the borderline between medicinal products and medical devices: Key takeaways

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The boundary between medicinal products and medical devices remains a recurring issue for companies developing or marketing borderline products and courts, which has already been the subject of numerous decisions. Recently,...more

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