European Union: Life Sciences, Biotechnology & Nanotechnology

Subscribe

Welcome to the Mondaq Food, Drugs, Healthcare, Life Sciences homepage, here you will find thought leadership articles, podcasts, videos and webinars providing insights covering topics such as Food and Drugs Law, Healthcare, Life Sciences, Biotechnology and Nanotechnology.

The New EU "Pharma Package": Global (Orphan) Marketing Authorization

In this fifth alert in our weekly series on the EU Pharma Package, we will delve into the global marketing authorization (GMA) concept which has largely remained untouched in the legislative proposal...

European Union Healthcare

CM

Crowell & Moring LLP

EU Confirms App Stores And Developers Are Subject To Medical Device Laws

The latest MDCG guidelines highlight a regulatory environment in the EU that is growing in depth and reach for software-based medical devices and diagnostics

European Union Healthcare

OC

Osborne Clarke

Nordic-Baltic Regional Division, July 21, 2025, Decision In First Instance, UPC_CFI_380/2023

The importance of the patent claims means, inter alia, that a narrowing interpretation of the claims which deviates from the broader general understanding of the terms used therein by the person...

BP

Bardehle Pagenberg

Economics Weekly Alert 24/2025

Υπενθυμίζουμε τους πελάτες μας για τις προθεσμίες καταβολής των ακόλουθων φόρων

Cyprus Strategy

Ki

KPMG in Cyprus

Medical Devices News - EU Commission Expands The Use Of Electronic Instructions For Use (EIFU)

European Union Healthcare

P

Plesner

First Health Apps Recommended By The Danish Board For Health Apps

Denmark Healthcare

P

Plesner

EU Consults On New GMP Rules For AI In Pharma Manufacturing

European Union Technology

AP

Arnold & Porter

L'IA médicale de Microsoft MAI-DxO bouscule la médecine

France Technology

HA

Haas Avocats

Neurotech : Au Coeur De L'esprit, Aux Frontières Du Droit

France Healthcare

HA

Haas Avocats

EU AI Act – Latest Regulatory Developments In Finland

Finland Technology

HS

Hannes Snellman Attorneys Ltd

European Commission Consultation Shapes High-risk AI Classification For Life Sciences In The EU

European Union Healthcare

OC

Osborne Clarke

EU Guidance Details How Technical And Clinical Standards Converge For AI In Medtech

European Union Healthcare

OC

Osborne Clarke

EU Updates Regulation On Electronic Instructions For Medical Devices

European Union Healthcare

P

PLMJ

Review Of A Year Of Administrative Case Law On Market Access

France Healthcare

D

Dechert

Governing AI, Powering Innovation Video Series

Ireland Technology

AC

Arthur Cox

Rising Geopolitical Tensions Ignite European Defense M&A

Worldwide Commercial

AO

A&O Shearman

The Principle Of Legality And The State's Duty To Remedy Its Own Unlawful Acts: A Note On Appeal 171/20 Before The Supreme Constitutional Court Of Cyprus

Cyprus Litigation

Phoebus, Christos Clerides & Associates LLC (Clerides Legal)

Generative AI & Employee IP: Who Owns Work Created By Employees Using AI Tools?

Worldwide Technology

E

Eurofast

Looking Ahead: Irish Developments - Horizon Scanner: Finance, May 2025

Ireland Finance

AC

Arthur Cox

Social Security Financing Bill For 2025

The Social Security Financing Bill is a cornerstone in the evolution of the life sciences regulatory framework in France. The 2025 edition was even more noteworthy, given that it had been initiated...

France Government

D

Dechert

DPIAs, Clinical Trials And AI: Health Sector And Lifesciences Updates

The healthcare and life sciences landscape is constantly evolving as organisations strive to harness rapid technological advances.

Ireland Technology

WF

William Fry

Life Sciences Outlook 2025 - Oliver O'Connor, Irish Pharmaceutical Healthcare Association

We talk to Oliver O'Connor, CEO, Irish Pharmaceutical Healthcare Association, about his role, his career journey and his views on some key issues faced by the industry.

Ireland Healthcare

AC

Arthur Cox

The New EU Product Liability Directive: Key Changes And Implications For The Life Sciences Sector

The new Product Liability Directive marks the most significant overhaul of product liability law in nearly four decades.

Ireland Healthcare

MF

McCann Fitzgerald

Life Sciences Outlook 2025 - Mergers And Acquisitions

Ireland Commercial

AC

Arthur Cox

Life Sciences Outlook 2025 - Environment, Construction And Real Estate

Ireland Real Estate

AC

Arthur Cox

LIfe Sciences Outlook 2025 - ESG And Energy

AC

Arthur Cox

LIfe Sciences Outlook 2025 - Litigation, Dispute Resolution And Products

Ireland Healthcare

AC

Arthur Cox

LIfe Sciences Outlook 2025 - Interview

Ireland Healthcare

AC

Arthur Cox

LIfe Sciences Outlook 2025 - Regulatory And Compliance

Ireland Healthcare

AC

Arthur Cox

LIfe Sciences Outlook 2025 - Introduction

Ireland Healthcare

AC

Arthur Cox

Doctrine du numérique en santé 2025 : un cadre renforcé pour une transformation numérique sécurisée et interopérable

France Healthcare

DA

Delsol Avocats

Data And AI In Medicines Regulation: EMA And HMA Work Plan

Ireland Healthcare

WF

William Fry

Commission Revamps MIR Form For MDR And IVDR Compliance

Ireland Healthcare

WF

William Fry

LIfe Sciences Outlook 2025 - Introduction

Life Sciences is a key sector for the Irish economy and our firm, and we are lucky to work with many of the world's largest and most innovative pharmaceutical...

Ireland Healthcare

AC

Arthur Cox

Doctrine du numérique en santé 2025 : un cadre renforcé pour une transformation numérique sécurisée et interopérable

Le 17 mars 2025, la Délégation au numérique en santé, l'Assurance Maladie, l'Agence du Numérique en Santé et le GIE SESAM-Vitale ont publié la version 2025 de la Doctrine du numérique en santé.

France Healthcare

DA

Delsol Avocats

Data And AI In Medicines Regulation: EMA And HMA Work Plan

As the European Union (EU) continues its digital health transformation, the European Medicines Agency (EMA) and the Heads of Medicines Agencies...

Ireland Healthcare

WF

William Fry

Commission Revamps MIR Form For MDR And IVDR Compliance

On 5 May 2025, the European Commission released an updated version of the Manufacturer...

Ireland Healthcare

WF

William Fry

EU Pharma Package: Trilogue Negotiations Commence

Ireland Healthcare

AC

Arthur Cox

Trends In Life Sciences M&A: Cybersecurity And AI Take Center Stage

Complementary perspectives on the challenges and opportunities shaping healthcare M&A. In Belgium, the implementation of the EU's NIS2 Directive has elevated cybersecurity to a central concern...

Belgium Technology

LL

Loyens & Loeff

The Worst E-Commerce Sites For Counterfeit Products Online

The '2024 Review of Notorious Markets for Counterfeiting and Piracy' by the US Trade Representative (USTR) reveals some positive developments in anti-counterfeiting by e-marketplaces...

European Union IP

NG

Novagraaf Group

Telemedicine And The Advanced Practice Of Medicine: An Irish Regulatory Perspective

Digital health solutions are increasingly becoming an integral part of healthcare products and systems.

Ireland Healthcare

AC

Arthur Cox

De EU AI-verordening

Met de inwerkingtreding van Verordening (EU) 2024/1689, beter bekend als de "Artificial...

European Union Technology

NG

Novagraaf Group

Strategies To Secure Supply Chains: Effective Contractual Approaches To Overcome Scarcity Challenges In The Supply Of Drugs, Medical Devices And Other Essential Goods

Luxembourg Commercial

LS

Luther S.A.

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

European Union Technology

JD

Jones Day

Irish FDI Screening Regime – Application To The Life Sciences Sector

Ireland Healthcare

M

Matheson

Second Medical Use Claims In The UPC System: Prerequisites And Mechanism Of Examination For Infringement

Germany Healthcare

BP

Bardehle Pagenberg

How Regulation Will Impact The Market In 2025 – Patent Protection And Access To Medicines

JP

JWP Patent & Trademark Attorneys

Regulatory Pulse Pharma And Medical Devices Newsletter: Issue #3

European Union Healthcare

SJ

Steptoe LLP

EU Medical Devices – Current Developments

Ireland Healthcare

AC

Arthur Cox

New German Government: Key Plans For The Life Sciences And Healthcare Sector

Germany Healthcare

AO

A&O Shearman

Changes In Reimbursement For Diabetes Control Devices

Portugal Healthcare

P

PLMJ

The New Rules For The Identification, Protection, And Resilience Of Critical Entities

Portugal Strategy

MV

Macedo Vitorino

EEDS : Jusqu'à 20 millions d'euros d'amende pour violation des données de santé

France International

HA

Haas Avocats

Generic Prescribing Of Medicines In Denmark?

Denmark Healthcare

P

Plesner

New CJEU Ruling On The Borderline Between Medicinal Products And Medical Devices: Key Takeaways

Germany Healthcare

AO

A&O Shearman

Irish Pharmaceutical Healthcare Association: Revised Code Effective 1 June 2025

Ireland Healthcare

AC

Arthur Cox

Proposal For A New Critical Medicines Act In The EU

Denmark Healthcare

P

Plesner

See more

Latest Videos

See more

What Regulatory Challenges Are Facing The Life Sciences Sector? (Video)

WF

William Fry

Webinar Video | Lunch & Learn: Life Sciences : Morceaux Choisis

A

Altius

Webinar Video | Life Sciences Session #2: Vaccine Liability: What If Vaccination Goes Wrong?

A

Altius

Launch Of Our Medical Device Publication (Video)

WF

William Fry

Understanding Sunshine Rules: How New Transparency Regulations In Europe Are Changing Relationships Between Industry And Health Care Professionals (Video)

HL

Hogan Lovells

Mondaq uses cookies on this website. By using our website you agree to our use of cookies as set out in our Privacy Policy.

Learn More