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European Union › New Regulations › 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...

Hogan Lovells on

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

Hogan Lovells

The path to circularity - Navigating through the EU’s sustainable product regulations on batteries, deforestation, ecodesign,...

Hogan Lovells on

The European Commission's new efforts to boost the EU's competitiveness through the Clean Industrial Deal and sweeping regulatory simplification have garnered significant attention. At the same time, circularity remains a...more

Herbert Smith Freehills Kramer

Accessibility Directive: Final countdown before application on 28 June 2025 - Businesses will be required to comply with new...

Herbert Smith Freehills Kramer on

On 28 June 2025, businesses will be required to comply with accessibility requirements applicable across the European Union (EU) for a broad range of products and services. These obligations stem from Directive (EU) 2019/882...more

Bracewell LLP

The Carbon Border Adjustment Mechanism: How to Navigate a Complex Mechanism

Bracewell LLP on

This note is dedicated to importers and producers of specific goods from countries outside the European Union, who will be subject to carbon pricing equivalent to that applied to European manufacturers of the same goods,...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

Hogan Lovells

How to leverage Advanced Purchase Agreements for military supply

Hogan Lovells on

The EU is introducing new regulations (EDIRPA and EDIP) to structure military procurement through pooled orders coordinated by the European Commission. Advanced Purchase Agreements (APAs), inspired by COVID-19 contracts,...more

Jones Day

Radical Changes to Europe's Product Liability Rules Adopted

Jones Day on

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

Goodwin

The NIS 2 Era Is Here: Are You Compliance-Ready?

Goodwin on

With the deadline for Member States to transpose the European Union’s updated Network and Information Systems Directive (Directive (EU) 2022/2555) (NIS 2 or Directive) into national law, with the Directive having passed on 18...more

Goodwin

EU Adopts Cyber Resilience Act for Connected Devices

Goodwin on

On October 10, 2024, the European Council officially adopted the Cyber Resilience Act (CRA), a regulation designed to ensure that products with digital features are secure to use and resilient against cyber threats, and that...more

King & Spalding

New European Batteries Regulation Has Been Adopted

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The European Union (EU) published its new Batteries Regulation on July 28, 2023. The long-awaited text, presented for the first time by the EU Commission in late 2020 and subject to negotiations since then, contains a...more

King & Spalding

Nearly a Century in the Making: Congress Modernizes FDA’s Regulation of Cosmetics

King & Spalding on

The Modernization of Cosmetics Regulation Act of 2022 (“MOCRA”) was signed into law alongside other reforms to the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) on December 29, 2022, as part of a broader consolidated...more

Hogan Lovells

New EU Battery Regulation – Additional challenges for companies

Hogan Lovells on

On 10 December 2020, the European Commission published a proposal for a new EU Regulation concerning batteries and waste batteries ("Battery Regulation"). The Battery Regulation is part of the European Green Deal and aims to...more

Hogan Lovells

European Commission adopts a Regulation on electronic instructions for use for MDR-covered devices

Hogan Lovells on

The European Commission adopted Implementing Regulation (EU) 2021/2226 which establishes the conditions under which instructions for use of certain medical devices subject to the Medical Devices Regulation can be provided in...more

Pillsbury Winthrop Shaw Pittman LLP

EU Takes Key Step in Taxonomy Rollout

Pillsbury Winthrop Shaw Pittman LLP on

European Commission issues first Delegated Act in the much-debated Taxonomy, moving forward with a multi-step approach in determining which activities are classified as sustainable. Nuclear energy, natural gas and...more

McDermott Will & Schulte

European SPC Manufacturing Waiver Goes into Force

McDermott Will & Schulte on

Newly issued EU Regulation 2019/933 provides supplementary protection certificate exemptions for exporting and stockpiling active pharmaceutical ingredients and medicinal products if certain anti-abuse requirements are met....more

McDermott Will & Schulte

Digital Health in the United Kingdom: The New Regulatory Environment Under the Medical Device Regulation

McDermott Will & Schulte on

The MDR and other recent developments in the health care regulatory landscape pose new opportunities and challenges for medical software companies and investors in digital health in the United Kingdom. Although the regulatory...more

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