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European Union › Health Technology

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 -
Knobbe Martens

TELA Bio Launches OviTex Inguinal Reinforced Tissue Matrix in Europe

Knobbe Martens on

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

Hogan Lovells

Early benefit assessment of medicinal products in Germany – first adaptions to AMNOG implementing the EU HTA Regulation

Hogan Lovells on

First adaption of German AMNOG to the EU HTA Regulation: With the German Federal Ministry of Health's recent adoption of the respective ordinance in Germany (AMNutzenV), the German legislator took a first step to integrate...more

A&O Shearman

Key regulatory changes impacting the healthcare industry in the EU and Germany in 2025

A&O Shearman on

The regulatory frameworks in the life sciences and healthcare sector keep evolving rapidly and dynamically. Several important legislative reforms have been adopted over the last years, which are set to impact players in the...more

Foley & Lardner LLP

European Medtech Companies: Why a U.S. Centric Patent Strategy is Essential for Long-Term Success

Foley & Lardner LLP on

As European medtech companies look to expand their presence in the U.S. market, understanding the intricacies of U.S. patent law becomes increasingly important. The U.S. market, being the largest for medical technologies,...more

BCLP

Navigating the FemTech regulatory landscape: which rules apply and what are the enforcement priorities?

BCLP on

Security, scale or functionality – pick two. This computer science principle coined by the late Professor Anderson is particularly relevant to the FemTech industry. Anderson’s Rule states that for a system to provide high...more

Proskauer Rose LLP

Q&A: What does 2024 have in store for European M&A?

Proskauer Rose LLP on

There is a wealth of dry powder to spend but 2023 has seen M&A deal activity hampered by rising costs of debt, unstable markets, supply chain issues, general political uncertainty, and fear of global recession. So, what does...more

Gardner Law

[Hybrid Event] MASTERING TOMORROW'S HEALTHCARE TECH: A CUTTING-EDGE APPROACH TO REGULATORY, COMPLIANCE, AND PRIVACY DEMANDS -...

Gardner Law on

FDA law firm Gardner Law and EU-based Fieldfisher discuss regulatory, compliance, and privacy matters relevant to high-tech healthcare products. - - Harnessing AI and Connected Devices in Medical Innovation in an...more

King & Spalding

EUROPE – New Interim Guidance on Parallel EMA-HTA Body Scientific Advice

King & Spalding on

On July 3, 2023, the European Medicines Agency (“EMA”) and the European Commission published a Guidance on Parallel EMA/HTA body Scientific Advice for the Interim Period (“Guideline”). The Guideline organizes parallel...more

Latham & Watkins LLP

New Regulation on Health Technology Assessment Seeks to Facilitate EU-Level Joint Clinical Assessments From 2025

Latham & Watkins LLP on

The regulation aims to harmonise clinical and scientific aspects of HTA to make innovative health technologies more widely available in the EU. Health technology assessment (HTA) is a multidisciplinary evidence-based...more

Hogan Lovells

Life Sciences and Health Care Horizons - 2020

Hogan Lovells on

We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more

Hogan Lovells

The importance of conscientious health data collection in European clinical trials

Hogan Lovells on

Clinical trials have become increasingly important for pharmaceutical companies and medical device manufacturers, which are focused on collecting as much data as possible on products and devices and their adverse effects. All...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

Knobbe Martens

European Commission Proposes Stronger Cooperation for Health Technology Assessment

Knobbe Martens on

On January 31, 2018, the European Commission adopted a legislative proposal with the aim of strengthening EU cooperation among Member States when conducting a Health Technology Assessment (HTA) of new medicines and certain...more

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