European Union: Life Sciences, Biotechnology & Nanotechnology

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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.

IP Biotechnology: Protecting Innovation In The Biotech Industry

Biotechnology combines the sciences of biology and technology to develop groundbreaking solutions in healthcare, agriculture, and environmental sustainability. Innovations in this sector, such as gene therapies...

Q

Questel

LD Hamburg, October 21, 2025, Order In The Proceedings For Provisional Measures, UPC_CFI_553/2025

To establish jurisdiction, at least the plausible allegation of infringing acts in the country in question is necessary.

BP

Bardehle Pagenberg

App Stores May Be Subject To EU Medical Device Regulatory Frameworks

In June this year, the EU regulatory framework for medical device software saw the adoption of two significant Medical Device Coordination Group guidelines (i) MDCG 2019-11; and (ii) MDCG 2025-4.

Ireland Healthcare

M

Matheson

Development Of A New EMA Guideline On The Clinical Evaluation Of Ready To Use Radiopharmaceuticals[1]

This post and the paper it links to were prepared at the instruction of Novartis; it reflects the views of the authors.

European Union Healthcare

AP

Arnold & Porter

Belgian Competition Authority Issues Guidance On Information Exchange Between Pharmaceutical Companies For Combination Therapies

Belgium Anti-trust

AO

A&O Shearman

Towards 2030: The EU's Vision For Life Sciences And Food Innovation

Ireland Healthcare

AC

Arthur Cox

GVZH Legal & Regulatory Updates - September Issue

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GVZH Advocates

The EU Excludes Economic Operators And Restricts The Use Of Medical Devices Originating In The People's Republic Of China

Worldwide Healthcare

BB

Bech-Bruun

European Commission Publishes New Variation Guidelines For Medicines

European Union Healthcare

AP

Arnold & Porter

Reporting A Hospital For Negligence: Practical Guide And Deadlines To Know

Italy Litigation

BI

Boccadutri International Law Firm

Combination Therapies In Belgium: How To Collaborate Without Breaching Competition Law

Belgium Anti-trust

A

Altius

Règlement IA : répartition des compétences entre les autorités nationales

France Healthcare

DA

Delsol Avocats

EU: New Guidance On The Interplay Between Medical Device Regulations And The AI Act

European Union Healthcare

P

Plesner

MITM : Publication Du Décret D'application Des Mesures Introduites Par La LFSS Pour 2024 Relatives À La Lutte Contre Les Pénuries De Médicaments

France Healthcare

DA

Delsol Avocats

Reverse Hybrid Mismatches: Is The CIV Carve-out Finally Decoded?

AO

A&O Shearman

Anti-ESG Update: Navigating The Backlash On ESG

Netherlands Commercial

LL

Loyens & Loeff

'Good Jobs' Podcast: Unpacking The Way Forward (Podcast)

Ireland Employment

LS

Lewis Silkin

Investment Firms Quarterly Legal And Regulatory Update: 1 October 2024 – 31 December 2024

Ireland Finance

DE

Dillon Eustace

Ep1 - Planning Ahead - The Planning And Development Act 2024 (Podcast)

Ireland Real Estate

WF

William Fry

Herbert Smith Freehills Kramer Comments For LSIPR On Small Molecule Litigation In The UPC

Life sciences-related cases started at a low level during the first years of the UPC's existence (about 25% of cases) and focused initially on the medtech sector.

KL

Herbert Smith Freehills Kramer LLP

Titanium Dioxide: General Court Strikes Down Classification As Human Carcinogen And ECJ Now Confirms

The European Commission often relies on scientific evidence for its regulatory decisions. But when challenged, how much deference is owed to the regulator's interpretation of the underlying science?

France Healthcare

A

Altius

European Union And United States Agree On Import Tariffs For Pharmaceutical Products

On 21 August 2025, the European Union and the United States published a Joint Statement (JS) "on a United States-European framework on an agreement on reciprocal...

Worldwide International

VB

Van Bael & Bellis

Publication d'un guide d'implémentation de l'éthique dans les systèmes d'intelligence artificielle en santé

Le 29 juillet 2025, la Délégation au Numérique en Santé (DNS) a publié un guide d'implémentation de l'éthique dans les systèmes d'intelligence...

France Technology

DA

Delsol Avocats

European Patent Attorney – Role, Qualifications & Career Path

Q

Questel

Pharmaceutical Advertising Laws And Regulations Ireland 2025

Ireland Healthcare

AC

Arthur Cox

The New EU "Pharma Package": Interplay With The Critical Medicines Act And Other Shortage Initiatives

European Union Healthcare

CM

Crowell & Moring LLP

A Heart Monitor At The Crossroads Of EU Data, Security And Medical Rules

Malta Healthcare

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GTG

Podcast Series Episode 2: Legal Framework Of Medically Assisted Reproduction In Greece

Greece Healthcare

BL

Bernitsas Law

The New EU "Pharma Package": Access Conditionalities And Shortage Measures – A Comparison Of Commission/Parliament/Council Positions

Belgium Healthcare

CM

Crowell & Moring LLP

Commission Guidelines For Providers Of General-purpose AI Models

European Union Healthcare

AP

Arnold & Porter

Exclusion Of Chinese Medical Devices From Public Procurements

Worldwide Government

P

Plesner

The EU Pharma Package: Status Following The Council's Adoption Of Its General Approach

Denmark Healthcare

P

Plesner

Italian Medical Device Payback: Italy Approves 75% Reduction On Medical Device Payback To End Disputes

Italy Healthcare

AO

A&O Shearman

Commission Guidelines For Providers Of General-purpose AI Models

On July 18, 2025, the European Commission released its guidelines on the obligations for providers of general-purpose AI (GPAI) models under the European Union's AI Act.

European Union Healthcare

AP

Arnold & Porter

Exclusion Of Chinese Medical Devices From Public Procurements

The European Commission has adopted its first-ever measure under the International Procurement Instrument prohibiting contracting authorities from procuring medical devices originating from China...

Worldwide Government

P

Plesner

The EU Pharma Package: Status Following The Council's Adoption Of Its General Approach

On 4 June 2025, the Council of the European Union adopted its general approach to the proposed reform of the EU pharmaceutical legislation (the Pharma Package).

Denmark Healthcare

P

Plesner

Italian Medical Device Payback: Italy Approves 75% Reduction On Medical Device Payback To End Disputes

Italy's payback system for medical devices has been a source of significant upheaval in the sector, with both domestic and international companies closely monitoring developments.

Italy Healthcare

AO

A&O Shearman

New Danish Pilot Program With Reimbursement For Certain Medicines Based On A Negotiated Confidential Price

Denmark Healthcare

P

Plesner

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

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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

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PLMJ

Review Of A Year Of Administrative Case Law On Market Access

France Healthcare

D

Dechert

Social Security Financing Bill For 2025

France Government

D

Dechert

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

Ireland Technology

WF

William Fry

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

Ireland Healthcare

AC

Arthur Cox

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

Ireland Healthcare

MF

McCann Fitzgerald

Life Sciences Outlook 2025 - Mergers And Acquisitions

Ireland Commercial

AC

Arthur Cox

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Latest Videos

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

WF

William Fry

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

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Altius

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

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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

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