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European Union › Regulatory Requirements › Manufacturers

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 -
Hogan Lovells

Key takeaways – UK MHRA’s response to consultation on ‘Medical Devices Regulations: Routes to market and in vitro diagnostic...

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The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published its responses to the consultation on Medical Device Regulations: Routes to market and in vitro diagnostic devices carried out last year....more

White & Case LLP

New EU Responsibility and Liability Landscape for Smart Medical Devices in a Global Context

White & Case LLP on

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

Eversheds Sutherland (US) LLP

Global Supply Chain Horizons - July 2025

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Welcome to the latest edition of our quarterly global supply chain horizons providing you with a update on the key developments from around the world. Cross-Border - China and the US trade deal - On June 27, the PRC...more

Dorsey & Whitney LLP

New EU Packaging Rules Impact Manufacturers

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The Packaging and Packaging Waste Regulation (Regulation (EU) 2025/40), the European Union’s new regulation concerning the packaging of products placed on the European market (PPWR), came into force on 11 February 2025....more

Davis Wright Tremaine LLP

European Accessibility Act Goes Live

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As of June 28, 2025, enforcement of the European Accessibility Act (EAA or the Act) can officially begin, marking a significant milestone for digital accessibility in the European Union (EU). The EAA establishes comprehensive...more

Barnea Jaffa Lande & Co.

Israel’s Import Reform: “What’s Good for Europe Is Good for Israel”

Barnea Jaffa Lande & Co. on

The “What’s Good for Europe Is Good for Israel” reform came into effect at the beginning of 2025, with considerable. This reform allows importers to import diverse products to Israel in a new standardization track, based on...more

Jones Day

The EU's Deforestation Regulation: Will There Be Further Changes?

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The EU's Deforestation Regulation (EUDR), designed to ensure that no products that contribute to deforestation are sold in, or exported from, the EU, continues to be criticized by EU Member States and major market players....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

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

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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

Jones Day

European Commission Proposes Further Prohibitions of Territorial Restrictions on Branded Products

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Future prohibition on territorial supply constraints would expand EU law to prohibit certain unilateral conduct by large manufacturers....more

Bergeson & Campbell, P.C.

EC Announces Low- and High-Risk Countries under the EUDR

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The European Commission (EC) released on May 22, 2025, the identity of the countries that present a low or high risk of deforestation in producing seven commodities (cattle, cocoa, coffee, palm oil, rubber, soy, and wood)...more

Mitratech Holdings, Inc

EU Cyber Resilience Act: How to Prepare Now

Mitratech Holdings, Inc on

The EU Cyber Resilience Act (CRA), adopted by the European Parliament in 2024, marks a major milestone in European cybersecurity legislation. As the first EU-wide law focused on the cybersecurity of digital products, it...more

Bergeson & Campbell, P.C.

Registration Open until May 16, 2025, for Joint Regulatory Risk Assessors Summit on Advancing Safety and Sustainability Assessment...

Bergeson & Campbell, P.C. on

On June 19 to June 20, 2025, the European Union (EU) Horizon Europe projects ACCORDs, iCare, MACRAMÉ, and nanoPASS are hosting a joint summit to address the needs of industry and regulators in assessing the safety and...more

Pillsbury Winthrop Shaw Pittman LLP

The EU’s Cyber Resilience Act: New Cybersecurity Requirements for Connected Products and Software

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The CRA will affect a broad range of digital products placed on the EU market (including by those based outside the EU), including connected hardware/devices, software and remote data processing solutions. The EU has adopted...more

Cooley LLP

Productwise Battery Shorts, Part 3: Substance Restrictions

Cooley LLP on

In Part 3 of our ‘Battery Shorts’ series, we look at the substance restrictions under the new European Union (EU) Batteries Regulation, which have applied since 18 August 2024....more

A&O Shearman

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

A&O Shearman on

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

Bergeson & Campbell, P.C.

CLP Changes And What They Mean For Commercial Operations — A Conversation with Karin Baron and Lioba Oerter

Bergeson & Campbell, P.C. on

This week I had the pleasure of speaking with Lioba Oerter, Director of Expert Services, 3E Expert Service Processing Centre (ESPC), and Karin F. Baron, Director of Hazard Communication and International Registration Strategy...more

Amundsen Davis LLC

Minimizing Product Liability Risks Caused by AI: Practical Tips for Businesses

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The use of artificial intelligence AI (AI) touches many sectors in the United States, and the business world is no exception. While this exciting development has proven useful for many businesses, it is also a new source of...more

Cooley LLP

Productwise Battery Shorts, Part 2: Conformity Assessment and CE Marking Requirements

Cooley LLP on

In Part 2 of our ‘Battery Shorts’ series, we look at the conformity assessment and CE marking requirements under the new European Union Batteries Regulation, which have applied since 18 August 2024....more

White & Case LLP

Eight key aspects to know about the EU Ecodesign for Sustainable Products Regulation

White & Case LLP on

The new Ecodesign for Sustainable Products Regulation1 ("ESPR"), which entered into force on 18 July 2024, is set to significantly reshape the regulatory landscape for companies operating in the European Union ("EU"). As part...more

Hogan Lovells

EU bans BPA in Food Contact Materials: what does it mean for industry?

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Jacqueline Mailly and Anastasia Vernikou of Hogan Lovells and Grégoire Paquet outline the details of the EU regulation introducing a ban on Bisphenol A (BPA) in food contact materials and its implications for industry. On 20...more

Hogan Lovells

Key Implications for Consumer Hardware Manufacturers

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On 28 June 2025, the key requirements of Directive (EU) 2019/882 – also known as the European Accessibility Act or “EAA” – will take effect. The EAA is expected to lift barriers to accessibility across the EU, in turn...more

Goodwin

Recent Ustekinumab and Denosumab Biosimilars Deals

Goodwin on

On Dec 24, 2024, Bio-Thera Solutions Inc. announced that it has partnered with Tabuk Pharmaceutical Manufacturing Company to commercialize BAT2206, a proposed ustekinumab biosimilar to Jansen’s STELARA, in Saudi Arabia....more

Jones Day

Radical Changes to Europe's Product Liability Rules Adopted

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Dramatic changes to EU product liability rules are expected to drive an increase in litigation....more

DLA Piper

EU: Cyber Resilience Act published in EU Official Journal

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On 20 November 2024, the EU Cyber Resilience Act (CRA) was published in the Official Journal of the EU, kicking off the phased implementation of the CRA obligations....more

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