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.

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

In this eighth alert in our weekly series on the EU Pharma Package, we continue our overview of initiatives with respect to security of supply and shortage prevention and mitigation.

European Union Healthcare

CM

Crowell & Moring LLP

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

A remote cardiac monitor is small enough to slip under the skin, but it changes the way a patient's heart is watched. Once in place it works quietly in the background, recording every beat and any irregular rhythm...

Malta Healthcare

G

GTG

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

In this episode, Senior Associates Pelina Leontiadou and Ria Venaki discuss recent legal developments and the legislative framework...

Greece Healthcare

BL

Bernitsas Law

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

In this seventh alert in our weekly series on the Pharma Package, we will discuss the increasing focus on shortages of medicinal products in the EU and the prevention...

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

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

Denmark Healthcare

P

Plesner

The New EU "Pharma Package": The "Bolar" Exemption – A Comparison Of Commission/Parliament/Council Positions

European Union IP

CM

Crowell & Moring LLP

European Biosimilar Updates – Formycon's Ustekinumab And Alvotech's Cetrolizumab Pegol

Germany Healthcare

GP

Goodwin Procter LLP

REACH Obligation To Register Imported Chemicals May Be Assumed By A Person Other Than The Buyer

European Union Healthcare

A

Altius

Updates To The EU Pharmacovigilance Rules: Key Takeaways For Marketing Authorisation Holders

European Union Healthcare

AP

Arnold & Porter

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

European Union Healthcare

CM

Crowell & Moring LLP

'Good Jobs' Proposals: What Changes May Be Happening To Pay And Benefits In Northern Ireland?

Ireland Employment

LS

Lewis Silkin

Governing AI, Powering Innovation Video Series

Ireland Technology

AC

Arthur Cox

Malta PR In 2025: New Benefits & Rules

Malta Immigration

AB

Attard Baldacchino

EU AI Act: Key Compliance Considerations Ahead Of August 2025

European Union Technology

GT

Greenberg Traurig, LLP

Is The World Adapting To The Digital Nomad? Part 1 (Video)

Italy Immigration

IL

Ius Laboris

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)

On 16 July 2025, Commission Implementing Regulation (EU) 2025/1234 will enter into force, amending the existing eIFU Regulation (EU) 2021/2226.

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

Social Security Financing Bill For 2025

France Government

D

Dechert

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

FAQ explains research exemption, dual conformity assessment and clinical data obligations for devices and diagnostics

European Union Healthcare

OC

Osborne Clarke

EU Updates Regulation On Electronic Instructions For Medical Devices

On 26 June 2025, Commission Implementing Regulation (EU) 2025/1234 was adopted, amending Implementing Regulation (EU) 2021/2226 with regard to medical devices for which instructions for use may be provided electronically.

European Union Healthcare

P

PLMJ

Review Of A Year Of Administrative Case Law On Market Access

After several years in which the Council of State had quashed multiple decisions on setting prices or reimbursement conditions...

France Healthcare

D

Dechert

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

Ireland Technology

WF

William Fry

LIfe Sciences Outlook 2025 - ESG And Energy

Ireland's National Energy Demand Strategy outlines regulatory decisions around smart energy services and customer demand flexibility and response.

AC

Arthur Cox

LIfe Sciences Outlook 2025 - Litigation, Dispute Resolution And Products

It is fair to say that the last number of years have seen a shift in terms of the shape of the liability regime for the life sciences industry, as well as industry more broadly.

Ireland Healthcare

AC

Arthur Cox

LIfe Sciences Outlook 2025 - Interview

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

LIfe Sciences Outlook 2025 - Regulatory And Compliance

2024 saw elections which led to a new European Commission and a new Irish Government. With these new administrations both in place, the last number of months have seen much activity in terms...

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

EU Pharma Package: Trilogue Negotiations Commence

Ireland Healthcare

AC

Arthur Cox

Konsultation der EU-Kommission zu Hochrisiko-KI-Systemen: Kernpunkte für den Life Sciences- und Health Care-Sektor

Germany Technology

GT

Greenberg Traurig, LLP

EU Commission Consultation On High-Risk AI Systems: Key Points For Life Sciences And Health Care

European Union Healthcare

GT

Greenberg Traurig, LLP

A New Lease Of Life For Organ Donation Regulation - The Human Tissue Act Becomes Law

Ireland Healthcare

RL

RDJ LLP

Council Position On EU Pharma Package Adopted

European Union Healthcare

AO

A&O Shearman

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

Belgium Technology

LL

Loyens & Loeff

The Worst E-Commerce Sites For Counterfeit Products Online

European Union IP

NG

Novagraaf Group

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

Ireland Healthcare

AC

Arthur Cox

De EU AI-verordening

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

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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

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

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